Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-03-02 @ 4:23 PM
Study NCT ID:
NCT03038867
Status:
COMPLETED
Last Update Posted:
2020-03-12
First Post:
2017-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of Duloxetine on Male Fertility
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007248', 'term': 'Infertility, Male'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068736', 'term': 'Duloxetine Hydrochloride'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mac4015@med.cornell.edu', 'phone': '212-746-5385', 'title': 'Research coordinator', 'organization': 'Weill Cornell Medical College'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year, 4 months', 'eventGroups': [{'id': 'EG000', 'title': 'Duloxetine', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week\n\nDuloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Sperm DNA Fragmentation at 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week\n\nDuloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 Weeks (primary time point of interest)', 'description': 'Number of participants with TUNEL values \\> 25% at 6 weeks in each treatment group', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '11 patients in the Duloxetine group and 7 patients in the Placebo group did not have Tunel data measured at 6 weeks (patients were not available).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Sperm DNA Fragmentation at 0 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week\n\nDuloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 weeks', 'description': 'Number of participants with Tunel Values \\> 25% at 0 Weeks (baseline) in each treatment group', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '5 patients in the Duloxetine group did not have Tunel data measured at 0 weeks (patients were not available)'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Sperm DNA Fragmentation at 2 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week\n\nDuloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 weeks', 'description': 'Number of participants with Tunel values \\> 25% at 2 weeks in each treatment group', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '12 patients in the Duloxetine group and 2 patients in the Placebo group did not have Tunel data at 2 weeks (patients were not available).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Sperm DNA Fragmentation at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week\n\nDuloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': 'Number of participants with Tunel values \\> 25% at 8 weeks in each treatment group', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '15 patients in the Duloxetine group and 4 patients in the Placebo group did not have Tunel data at 8 weeks (patients were not available).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Sperm DNA Fragmentation at 10 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week\n\nDuloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 Weeks', 'description': 'Number of participants with Tunel values \\> 25% at 10 weeks in each treatment group', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '18 patients in the Duloxetine group and 4 patients in the Placebo group did not have Tunel data at 10 weeks (patients were not available).'}, {'type': 'SECONDARY', 'title': 'Sperm Concentration at 0 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week\n\nDuloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '57.4', 'spread': '40.3', 'groupId': 'OG000'}, {'value': '50.2', 'spread': '33.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 weeks', 'description': 'Sperm concentration (number of sperm/mL) in semen analysis at 0 weeks', 'unitOfMeasure': 'Number of sperm/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 patients in the Duloxetine group did not have sperm concentration measured at 0 weeks (patients were not available).'}, {'type': 'SECONDARY', 'title': 'Sperm Concentration at 2 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week\n\nDuloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '48.9', 'spread': '38.7', 'groupId': 'OG000'}, {'value': '50.0', 'spread': '41.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Sperm concentration (number of sperm/mL) in semen analysis at 2 weeks', 'unitOfMeasure': 'Number of sperm/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '10 patients in the Duloxetine group and 2 patients in the Placebo group did not have sperm concentration measured at 2 weeks (patients were not available).'}, {'type': 'SECONDARY', 'title': 'Sperm Concentration at 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week\n\nDuloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '44.6', 'spread': '24.2', 'groupId': 'OG000'}, {'value': '43.9', 'spread': '32.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Sperm concentration (number of sperm/mL) in semen analysis at 6 weeks', 'unitOfMeasure': 'Number of sperm/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '11 patients in the Duloxetine group and 5 patients in the Placebo group did not have sperm concentration measured at 6 weeks (patients were not available).'}, {'type': 'SECONDARY', 'title': 'Sperm Concentration at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week\n\nDuloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '45.7', 'spread': '29.8', 'groupId': 'OG000'}, {'value': '47.1', 'spread': '28.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Sperm concentration (number of sperm/mL) in semen analysis at 8 weeks', 'unitOfMeasure': 'Number of sperm/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '14 patients in the Duloxetine group and 2 patients in the Placebo group did not have sperm concentration measured at 8 weeks (patients were not available).'}, {'type': 'SECONDARY', 'title': 'Sperm Concentration at 10 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week\n\nDuloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '42.0', 'spread': '26.3', 'groupId': 'OG000'}, {'value': '42.7', 'spread': '26.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 Weeks', 'description': 'Sperm concentration (number of sperm/mL) in semen analysis at 10 weeks', 'unitOfMeasure': 'Number of sperm/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '16 patients in the Duloxetine group and 2 patients in the Placebo group did not have sperm concentration measured at 10 weeks (patients were not available).'}, {'type': 'SECONDARY', 'title': 'Sperm Motility at 0 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week\n\nDuloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '61.7', 'spread': '9.5', 'groupId': 'OG000'}, {'value': '59.7', 'spread': '11.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 weeks', 'description': 'Sperm motility (mean percent) at 0 weeks', 'unitOfMeasure': 'percent motility', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 patients in the Duloxetine group did not have motility measured at 0 weeks (patients were not available).'}, {'type': 'SECONDARY', 'title': 'Sperm Motility at 2 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week\n\nDuloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '54.3', 'spread': '13.3', 'groupId': 'OG000'}, {'value': '55.2', 'spread': '13.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Sperm motility (mean percent) at 2 weeks', 'unitOfMeasure': 'percent motility', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '11 patients in the Duloxetine group and 2 patients in the Placebo group did not have motility measured at 2 weeks (patients were not available).'}, {'type': 'SECONDARY', 'title': 'Sperm Motility at 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week\n\nDuloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '57.2', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '50.4', 'spread': '20.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Sperm motility (mean percent) at 6 weeks', 'unitOfMeasure': 'percent motility', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '11 patients in the Duloxetine group and 5 patients in the Placebo group did not have motility measured at 6 weeks (patients were not available).'}, {'type': 'SECONDARY', 'title': 'Sperm Motility at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week\n\nDuloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '51.1', 'spread': '18.6', 'groupId': 'OG000'}, {'value': '58.5', 'spread': '12.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Sperm motility (mean percent) at 8 weeks', 'unitOfMeasure': 'percent motility', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '13 patients in the Duloxetine group and 2 patients in the Placebo group did not have motility measured at 8 weeks (patients were not available).'}, {'type': 'SECONDARY', 'title': 'Sperm Motility at 10 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week\n\nDuloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '54.4', 'spread': '17.4', 'groupId': 'OG000'}, {'value': '53.9', 'spread': '19.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 Weeks', 'description': 'Sperm motility (mean percent) at 10 weeks', 'unitOfMeasure': 'percent motility', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '15 patients in the Duloxetine group and 3 patients in the Placebo group did not have motility measured at 10 weeks (patients were not available).'}, {'type': 'SECONDARY', 'title': 'Sperm Head Defects at 0 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week\n\nDuloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '88.4', 'spread': '16.0', 'groupId': 'OG000'}, {'value': '89.9', 'spread': '8.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 weeks', 'description': 'Sperm head defects (mean number) at 0 weeks', 'unitOfMeasure': 'defects', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 patients in the Duloxetine group did not have head defects measured at 0 weeks (patients were not available).'}, {'type': 'SECONDARY', 'title': 'Sperm Head Defects at 2 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week\n\nDuloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '91.5', 'spread': '4.02', 'groupId': 'OG000'}, {'value': '90.7', 'spread': '7.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Sperm head defects (mean number) at 2 weeks', 'unitOfMeasure': 'defects', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '11 patients in the Duloxetine group and 2 patients in the Placebo group did not have head defects measured at 2 weeks (patients were not available).'}, {'type': 'SECONDARY', 'title': 'Sperm Head Defects at 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week\n\nDuloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '91.6', 'spread': '4.38', 'groupId': 'OG000'}, {'value': '91.3', 'spread': '10.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Sperm head defects (mean number) at 6 weeks', 'unitOfMeasure': 'defects', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '11 patients in the Duloxetine group and 5 patients in the Placebo group did not have head defects measured at 6 weeks (patients were not available).'}, {'type': 'SECONDARY', 'title': 'Sperm Head Defects at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week\n\nDuloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '92.3', 'spread': '4.54', 'groupId': 'OG000'}, {'value': '88.7', 'spread': '15.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Sperm head defects (mean number) at 8 weeks', 'unitOfMeasure': 'defects', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '13 patients in the Duloxetine group and 2 patients in the Placebo group did not have head defects measured at 8 weeks (patients were not available).'}, {'type': 'SECONDARY', 'title': 'Sperm Head Defects at 10 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week\n\nDuloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '90.8', 'spread': '5.65', 'groupId': 'OG000'}, {'value': '88.3', 'spread': '16.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 Weeks', 'description': 'Sperm head defects (mean number) at 10 weeks', 'unitOfMeasure': 'defects', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '15 patients in the Duloxetine group and 3 patients in the Placebo group did not have head defects measured at 10 weeks (patients were not available).'}, {'type': 'SECONDARY', 'title': 'Sperm Neck Defects at 0 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week\n\nDuloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '1.36', 'spread': '2.97', 'groupId': 'OG000'}, {'value': '2.55', 'spread': '4.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 weeks', 'description': 'Sperm neck defects (mean number) at 0 weeks', 'unitOfMeasure': 'defects', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 patients in the Duloxetine group did not have neck defects measured at 0 weeks (patients were not available).'}, {'type': 'SECONDARY', 'title': 'Sperm Neck Defects at 2 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week\n\nDuloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '2.65', 'spread': '5.83', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '3.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Sperm neck defects (mean number) at 2 weeks', 'unitOfMeasure': 'defects', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '11 patients in the Duloxetine 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'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week\n\nDuloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '2.64', 'spread': '11.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Sperm tail defects (mean number) at 6 weeks', 'unitOfMeasure': 'defects', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '11 patients in the Duloxetine group and 7 patients in the Placebo group did not have tail defects measured at 6 weeks (patients were not available).'}, {'type': 'SECONDARY', 'title': 'Sperm Tail Defects at 8 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[{'measurements': [{'value': '485', 'spread': '170', 'groupId': 'OG000'}, {'value': '438', 'spread': '174', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Testosterone level (ng/dL) at 6 weeks', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '12 patients in the Duloxetine group and 2 patients in the Placebo group did not have testosterone measured at 6 weeks (patients were not available).'}, {'type': 'SECONDARY', 'title': 'Testosterone Level at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week\n\nDuloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 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orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '445', 'spread': '165', 'groupId': 'OG000'}, {'value': '509', 'spread': '167', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 Weeks', 'description': 'Testosterone level (ng/dL) at 10 weeks', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '21 patients in the Duloxetine group and 8 patients in the Placebo group did not have testosterone measured at 10 weeks (patients were not available).'}, {'type': 'SECONDARY', 'title': 'Estrogen Level at 0 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week\n\nDuloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '51.8', 'spread': '39.4', 'groupId': 'OG000'}, {'value': '58.5', 'spread': '51.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 weeks', 'description': 'Estrogen level (pg/mL) at 0 weeks', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '6 patients in the Duloxetine group and 3 patients in the Placebo group did not have estrogen measured at 0 weeks (patients were not available).'}, {'type': 'SECONDARY', 'title': 'Estrogen Level at 2 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week\n\nDuloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '53.0', 'spread': '37.6', 'groupId': 'OG000'}, {'value': '44.4', 'spread': '25.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Estrogen level (pg/mL) at 2 weeks', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '16 patients in the Duloxetine group did not have estrogen measured at 2 weeks (patients were not available).'}, {'type': 'SECONDARY', 'title': 'Estrogen Level at 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estrogen measured at 6 weeks (patients were not available).'}, {'type': 'SECONDARY', 'title': 'Estrogen Level at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week\n\nDuloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '49.3', 'spread': '31.9', 'groupId': 'OG000'}, {'value': '39.0', 'spread': '24.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Estrogen level (pg/mL) at 8 weeks', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '17 patients in the Duloxetine group and 6 patients in the Placebo group did not have testosterone measured at 8 weeks (patients were not available).'}, {'type': 'SECONDARY', 'title': 'Estrogen Level at 10 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week\n\nDuloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '31.7', 'spread': '12.2', 'groupId': 'OG000'}, {'value': '133', 'spread': '467', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 Weeks', 'description': 'Estrogen level (pg/mL) at 10 weeks', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '23 patients in the Duloxetine group and 8 patients in the Placebo group did not have estrogen measured at 10 weeks (patients were not available).'}, {'type': 'SECONDARY', 'title': 'Prolactin Level at 0 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week\n\nDuloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '11.9', 'spread': '5.78', 'groupId': 'OG000'}, {'value': '12.4', 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'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': 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'timeFrame': '0 weeks', 'description': 'Number of participants with Tunel Values \\> 25% at 0 Weeks (baseline) in each treatment group'}, {'measure': 'Number of Participants With Abnormal Sperm DNA Fragmentation at 2 Weeks', 'timeFrame': '2 weeks', 'description': 'Number of participants with Tunel values \\> 25% at 2 weeks in each treatment group'}, {'measure': 'Number of Participants With Abnormal Sperm DNA Fragmentation at 8 Weeks', 'timeFrame': '8 weeks', 'description': 'Number of participants with Tunel values \\> 25% at 8 weeks in each treatment group'}, {'measure': 'Number of Participants With Abnormal Sperm DNA Fragmentation at 10 Weeks', 'timeFrame': '10 Weeks', 'description': 'Number of participants with Tunel values \\> 25% at 10 weeks in each treatment group'}], 'secondaryOutcomes': [{'measure': 'Sperm Concentration at 0 Weeks', 'timeFrame': '0 weeks', 'description': 'Sperm concentration (number of sperm/mL) in semen analysis at 0 weeks'}, {'measure': 'Sperm Concentration at 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Motility at 8 Weeks', 'timeFrame': '8 weeks', 'description': 'Sperm motility (mean percent) at 8 weeks'}, {'measure': 'Sperm Motility at 10 Weeks', 'timeFrame': '10 Weeks', 'description': 'Sperm motility (mean percent) at 10 weeks'}, {'measure': 'Sperm Head Defects at 0 Weeks', 'timeFrame': '0 weeks', 'description': 'Sperm head defects (mean number) at 0 weeks'}, {'measure': 'Sperm Head Defects at 2 Weeks', 'timeFrame': '2 weeks', 'description': 'Sperm head defects (mean number) at 2 weeks'}, {'measure': 'Sperm Head Defects at 6 Weeks', 'timeFrame': '6 weeks', 'description': 'Sperm head defects (mean number) at 6 weeks'}, {'measure': 'Sperm Head Defects at 8 Weeks', 'timeFrame': '8 weeks', 'description': 'Sperm head defects (mean number) at 8 weeks'}, {'measure': 'Sperm Head Defects at 10 Weeks', 'timeFrame': '10 Weeks', 'description': 'Sperm head defects (mean number) at 10 weeks'}, {'measure': 'Sperm Neck Defects at 0 Weeks', 'timeFrame': '0 weeks', 'description': 'Sperm neck defects (mean number) at 0 weeks'}, {'measure': 'Sperm Neck Defects at 2 Weeks', 'timeFrame': '2 weeks', 'description': 'Sperm neck defects (mean number) at 2 weeks'}, {'measure': 'Sperm Neck Defects at 6 Weeks', 'timeFrame': '6 weeks', 'description': 'Sperm neck defects (mean number) at 6 weeks'}, {'measure': 'Sperm Neck Defects at 8 Weeks', 'timeFrame': '8 weeks', 'description': 'Sperm neck defects (mean number) at 8 weeks'}, {'measure': 'Sperm Neck Defects at 10 Weeks', 'timeFrame': '10 Weeks', 'description': 'Sperm neck defects (mean number) at 10 weeks'}, {'measure': 'Sperm Tail Defects at 0 Weeks', 'timeFrame': '0 weeks', 'description': 'Sperm tail defects (mean number) at 0 weeks'}, {'measure': 'Sperm Tail Defects at 2 Weeks', 'timeFrame': '2 weeks', 'description': 'Sperm tail defects (mean number) at 2 weeks'}, {'measure': 'Sperm Tail Defects at 6 Weeks', 'timeFrame': '6 weeks', 'description': 'Sperm tail defects (mean number) at 6 weeks'}, {'measure': 'Sperm Tail Defects at 8 Weeks', 'timeFrame': '8 weeks', 'description': 'Sperm tail defects (mean number) at 8 weeks'}, {'measure': 'Sperm Tail Defects at 10 Weeks', 'timeFrame': '10 Weeks', 'description': 'Sperm tail defects (mean number) at 10 weeks'}, {'measure': 'Testosterone Level at 0 Weeks', 'timeFrame': '0 weeks', 'description': 'Testosterone level (ng/dL) at 0 weeks'}, {'measure': 'Testosterone Level at 2 Weeks', 'timeFrame': '2 weeks', 'description': 'Testosterone level (ng/dL) at 2 weeks'}, {'measure': 'Testosterone Level at 6 Weeks', 'timeFrame': '6 weeks', 'description': 'Testosterone level (ng/dL) at 6 weeks'}, {'measure': 'Testosterone Level at 8 Weeks', 'timeFrame': '8 weeks', 'description': 'Testosterone level (ng/dL) at 8 weeks'}, {'measure': 'Testosterone Level at 10 Weeks', 'timeFrame': '10 Weeks', 'description': 'Testosterone level (ng/dL) at 10 weeks'}, {'measure': 'Estrogen Level at 0 Weeks', 'timeFrame': '0 weeks', 'description': 'Estrogen level (pg/mL) at 0 weeks'}, {'measure': 'Estrogen Level at 2 Weeks', 'timeFrame': '2 weeks', 'description': 'Estrogen level (pg/mL) at 2 weeks'}, {'measure': 'Estrogen Level at 6 Weeks', 'timeFrame': '6 weeks', 'description': 'Estrogen level (pg/mL) at 6 weeks'}, {'measure': 'Estrogen Level at 8 Weeks', 'timeFrame': '8 weeks', 'description': 'Estrogen level (pg/mL) at 8 weeks'}, {'measure': 'Estrogen Level at 10 Weeks', 'timeFrame': '10 Weeks', 'description': 'Estrogen level (pg/mL) at 10 weeks'}, {'measure': 'Prolactin Level at 0 Weeks', 'timeFrame': '0 weeks', 'description': 'Prolactin level (ng/mL) at 0 weeks'}, {'measure': 'Prolactin Level at 2 Weeks', 'timeFrame': '2 weeks', 'description': 'Prolactin level (ng/mL) at 2 weeks'}, {'measure': 'Prolactin Level at 6 Weeks', 'timeFrame': '6 weeks', 'description': 'Prolactin level (ng/mL) at 6 weeks'}, {'measure': 'Prolactin Level at 8 Weeks', 'timeFrame': '8 weeks', 'description': 'Prolactin level (ng/mL) at 8 weeks'}, {'measure': 'Prolactin Level at 10 Weeks', 'timeFrame': '10 Weeks', 'description': 'Prolactin level (ng/mL) at 10 weeks'}, {'measure': 'Luteinizing Hormone Level at 0 Weeks', 'timeFrame': '0 weeks', 'description': 'Luteinizing hormone level (mIU/mL) at 0 weeks'}, {'measure': 'Luteinizing Hormone Level at 2 Weeks', 'timeFrame': '2 weeks', 'description': 'Luteinizing hormone level (mIU/mL) at 2 weeks'}, {'measure': 'Luteinizing Hormone Level at 6 Weeks', 'timeFrame': '6 weeks', 'description': 'Luteinizing hormone level (mIU/mL) at 6 weeks'}, {'measure': 'Luteinizing Hormone Level at 8 Weeks', 'timeFrame': '8 weeks', 'description': 'Luteinizing hormone level (mIU/mL) at 8 weeks'}, {'measure': 'Luteinizing Hormone Level at 10 Weeks', 'timeFrame': '10 Weeks', 'description': 'Luteinizing hormone level (mIU/mL) at 10 weeks'}, {'measure': 'Follicle Stimulating Hormone Level at 0 Weeks', 'timeFrame': '0 weeks', 'description': 'Follicle stimulating hormone level (mIU/mL) at 0 weeks'}, {'measure': 'Follicle Stimulating Hormone Level at 2 Weeks', 'timeFrame': '2 weeks', 'description': 'Follicle stimulating hormone level (mIU/mL) at 2 weeks'}, {'measure': 'Follicle Stimulating Hormone Level at 6 Weeks', 'timeFrame': '6 weeks', 'description': 'Follicle stimulating hormone level (mIU/mL) at 6 weeks'}, {'measure': 'Follicle Stimulating Hormone Level at 8 Weeks', 'timeFrame': '8 weeks', 'description': 'Follicle stimulating hormone level (mIU/mL) at 8 weeks'}, {'measure': 'Follicle Stimulating Hormone Level at 10 Weeks', 'timeFrame': '10 Weeks', 'description': 'Follicle stimulating hormone level (mIU/mL) at 10 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility, Male', 'Depression']}, 'descriptionModule': {'briefSummary': 'The investigators are conducting a placebo-controlled, randomized control trial with duloxetine in healthy, fertile men not previously on any antidepressants. Participants will be randomized to either the duloxetine or placebo groups for 6 weeks. The investigators will assess changes in sperm DNA fragmentation at 0, 2, 6, 8, and 10 weeks. Other outcomes measured will include semen parameters (sperm concentration, motility, morphology), hormone levels (testosterone, estrogen, prolactin, LH, FSH), and sexual function (IIEF and MSHQ) surveys.', 'detailedDescription': 'Antidepressant medications are commonly prescribed in the USA not only for depression, but also for anxiety disorders such as generalized anxiety disorder and obsessive-compulsive disorder, premature ejaculation, post-traumatic stress disorder, and neuropathic pain. Despite being widely prescribed in the United States in men of reproductive age, the impact of antidepressants on fertility has not been extensively studied.\n\nAfter noticing worsened semen parameters in men on anti-depressants, the investigators performed the first prospective study to demonstrate a deleterious impact of selective serotonin reuptake inhibitors (SSRI) on sperm DNA integrity, which has been linked to reproductive outcomes. Further small studies have corroborated the negative impact of SSRIs on male fertility, as assessed by semen parameters and/or sperm DNA integrity.\n\nNo studies have examined the impact of a newer, but similar, class of antidepressant - the serotonin-norepinephrine reuptake inhibitor (SNRI). Like SSRIs, SNRIs inhibit the reuptake of serotonin, but also act on norepinephrine. The use of SNRIs has increased recently due to their slightly improved efficacy profile when compared to SSRIs. Duloxetine is an SNRI and is one of the most commonly prescribed anti-depressants in the United States.\n\nThe investigators are conducting this trial to determine whether or not the administration of duloxetine will result in a deterioration in sperm DNA fragmentation in healthy, fertile men.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men aged 18-65 years old;\n* normal or borderline semen analysis (sperm concentration \\> 10 million/mL, sperm motility \\> 30%, sperm morphology \\> 3%);\n* willing to engage in sexual activity (alone or with a partner) at least once per week for the duration of the study;\n* capable of providing semen sample.\n\nExclusion Criteria:\n\n* Clinically detected varicocele;\n* oligoasthenoteratospermia or azoospermia on semen analysis;\n* ongoing attempts to initiate pregnancy;\n* current sexual dysfunction (classified as moderate or worse on IIEF);\n* history of seizure disorder;\n* history of previous chemotherapy or radiation therapy;\n* current psychiatric history or history of bipolar disorder;\n* family history of bipolar disorder, depression, or suicide;\n* use of any psychotropic medications or anticonvulsants;\n* use of sleeping pills more than once per week;\n* use of any hormonal medications on a daily or intermittent basis during the preceding 3 months;\n* use of medications which may affect hormone measures and/or sexual function;\n* inability to read, follow instructions, or complete questionnaires in English;\n* consumption of tobacco or illicit drugs;\n* consumption of \\>2oz of alcohol daily.'}, 'identificationModule': {'nctId': 'NCT03038867', 'briefTitle': 'Impact of Duloxetine on Male Fertility', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Impact of Duloxetine on Male Fertility', 'orgStudyIdInfo': {'id': '1603017099'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Duloxetine', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week', 'interventionNames': ['Drug: Duloxetine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Duloxetine', 'type': 'DRUG', 'description': 'Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week', 'armGroupLabels': ['Duloxetine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Peter Schlegel, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Weill Medical College of Cornell University'}, {'name': 'Nahid Punjani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}