Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2026-02-21 @ 11:54 PM
Study NCT ID:
NCT02070718
Status:
COMPLETED
Last Update Posted:
2015-07-01
First Post:
2014-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Kappa Agonist on Hot Flashes in Menopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019584', 'term': 'Hot Flashes'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010423', 'term': 'Pentazocine'}, {'id': 'D009270', 'term': 'Naloxone'}], 'ancestors': [{'id': 'D001575', 'term': 'Benzomorphans'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-29', 'studyFirstSubmitDate': '2014-02-21', 'studyFirstSubmitQcDate': '2014-02-21', 'lastUpdatePostDateStruct': {'date': '2015-07-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Serum Follicle Stimulating Hormone', 'timeFrame': 'Baseline only', 'description': 'Baseline (1st visit) single time point'}, {'measure': 'Serum Estradiol', 'timeFrame': 'Baseline only', 'description': 'Baseline (1st visit) single time point only.'}], 'primaryOutcomes': [{'measure': 'Hot Flashes', 'timeFrame': '1-4 weeks', 'description': 'Objectively measured hot flash frequency by changes in skin conductance over 8 hours on 3 separate study visits 3-14 days apart.'}], 'secondaryOutcomes': [{'measure': 'Subjectively measured hot flashes', 'timeFrame': '1-4 weeks', 'description': 'Self-reported diary documentation of time and occurence of hot flashes and intensity of hot flashes over 8 hours on 3 separate study visits 3-14 days apart.'}, {'measure': 'Change in Serum Leutinizing Hormone', 'timeFrame': '1-4 weeks', 'description': 'Serum collected at each visit baseline (before administration of treatment) and at 20-minute intervals over 8 hours on 3 separate study visits 3-14 days apart.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hot flashes', 'menopause', 'kappa agonist'], 'conditions': ['Treatment of Menopausal Hot Flashes']}, 'referencesModule': {'references': [{'pmid': '25988798', 'type': 'DERIVED', 'citation': 'Oakley AE, Steiner RA, Chavkin C, Clifton DK, Ferrara LK, Reed SD. kappa Agonists as a novel therapy for menopausal hot flashes. Menopause. 2015 Dec;22(12):1328-34. doi: 10.1097/GME.0000000000000476.'}]}, 'descriptionModule': {'briefSummary': 'Studies suggest that kappa agonists (KA) and peripherally restricted kappa agonists (PRKAs) may affect thermoregulation. This pilot study has the aim to establish proof of concept regarding efficacy of an oral kappa agonist (KA) for the treatment of menopausal hot flashes.', 'detailedDescription': 'To establish proof of concept regarding efficacy of an oral kappa agonist (KA), Pentazocine/ Naloxone 50/0.5 mg, for the treatment of menopausal hot flashes.\n\nTo gather data in support of a future proposal to study the safety and efficacy of a PRKA, a type of KA, for amelioration of menopausal hot flashes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy women 45-60 years of age; 12 months amenorrhea\n2. Documentation of \\> 8 moderate to severe, daily hot flashes during one week of baseline monitoring using daily diaries\n3. Availability of a family member or friend to drive participant home following clinic visits\n\nExclusion Criteria:\n\n1. Use of hormonal prescription medication or supplements for vasomotor symptoms (VMS)\n2. Use of narcotics\n3. Use of SSRI (selective serotonin reuptake inhibitor)/SNRI (serotonin-norepinephrine reuptake inhibitors), gabapentin, MAOI (monoamine oxidase inhibitor), anti-epileptics, sedatives\n4. History of polycystic ovarian syndrome or hirsutism\n5. Current history of depression\n6. Any chronic or acute medical illnesses including renal, hepatic, pulmonary diseases, or seizures\n7. Substance abuse\n8. Severe corn allergy\n9. Known allergic reaction to pentazocine or naloxone\n10. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data\n11. Hysterectomy\n12. Use of anticholinergic medications\n13. Lactating or pregnant'}, 'identificationModule': {'nctId': 'NCT02070718', 'briefTitle': 'Effects of a Kappa Agonist on Hot Flashes in Menopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Effects of a Kappa Agonist on Hot Flashes in Menopausal Women', 'orgStudyIdInfo': {'id': '43952-B'}, 'secondaryIdInfos': [{'id': 'GYN-01-2012', 'type': 'OTHER', 'domain': 'University of Washington'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Cornstarch, National Formulary', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Standard Dose Kappa Agonist', 'description': 'Pentazocine/Naloxone 50/0.5 mg', 'interventionNames': ['Drug: Standard Dose Kappa Agonist']}, {'type': 'EXPERIMENTAL', 'label': 'Half Dose Kappa Agonist', 'description': 'Pentazocine/Naloxone 25/0.25 mg', 'interventionNames': ['Drug: Half Dose Kappa Agonist']}], 'interventions': [{'name': 'Standard Dose Kappa Agonist', 'type': 'DRUG', 'otherNames': ['Pentazocine/Naloxone 50/0.5 mg'], 'armGroupLabels': ['Standard Dose Kappa Agonist']}, {'name': 'Half Dose Kappa Agonist', 'type': 'DRUG', 'otherNames': ['Pentazocine/Naloxone 25/0.25 mg'], 'armGroupLabels': ['Half Dose Kappa Agonist']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Susan D Reed, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}, {'name': "Office of Research on Women's Health (ORWH)", 'class': 'NIH'}, {'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Obstetrics & Gynecology', 'investigatorFullName': 'Susan Reed', 'investigatorAffiliation': 'University of Washington'}}}}