Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT01331551
Status:
COMPLETED
Last Update Posted:
2018-08-02
First Post:
2011-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mesalamine and Reproductive Health Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood for hormones, urine for phthalates, semen for DNA and RNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-31', 'studyFirstSubmitDate': '2011-04-06', 'studyFirstSubmitQcDate': '2011-04-07', 'lastUpdatePostDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Altered semen quality and sperm transcriptome analysis', 'timeFrame': 'Initial analysis takes place approximately 4-5 months after patient enrolls and after he has completed first crossover of medication. The second phase takes place about 8-10 months later after he crosses back to original medication.'}], 'secondaryOutcomes': [{'measure': 'Serum levels of reproductive hormones', 'timeFrame': 'Analysis of hormone levels take place at the same intervals described above, 4-5 months after enrollment and then again 8-10 months after enrollment when patient has resumed taking orginal medication.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Inflammatory Bowel disease'], 'conditions': ['Colitis Ulcerative', 'Crohn Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the relationship of high exposure to dibutyl phthalate (DBP) from the use of Asacol with clinical and intermediate markers of male fertility, including semen quality, sperm DNA damage, transcript profiles of sperm mRNA and sncRNAs, and reproductive hormones.\n\nHypothesis 1: High exposure to DBP from the use of Asacol is associated with decreased sperm concentration and motility, and increased sperm DNA damage.\n\nHypothesis 2: High exposure to DBP from the use of Asacol is associated with decreased serum testosterone, altered LH:testosterone ratio, and decreased inhibin-B.\n\nHypothesis 3: High exposure to DBP from the use of Asacol is associated with altered transcript profiles of sperm mRNAs and sncRNAs.', 'detailedDescription': 'There are 2 ways you can participate in the study.\n\nOPTION 1 involves 6 one-hour visits to the Massachusetts General Hospital (MGH) Andrology Clinic over a 9 month period. At each visit you would be asked to fill out questionnaires and to provide a urine, semen, and blood sample. Following Visit 2, you are asked to switch your brand of mesalamine medication. After 4 months, you change back to your original brand of medication. The change in medication will be done in consultation with your primary GI doctor. If the cost of co-payment is greater for the new brand of medication, we will provide compensation to cover the difference. In the case you do not have prescription drug health insurance coverage, the study will reimburse up to $4000 to cover the cost for Asacol, Pentasa or Lialda medication taken during your study participation.\n\nOPTION 2 involves 4 one-hour visits to MGH Andrology clinic. At each visit you complete questionnaires and provide a blood, urine and semen sample. You are eligible for Option 2 if you are currently taking Asacol or Asacol HD and do not want to change your medication.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men between the ages of 18-55 who have inflammatory bowel disease.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be taking mesalamine medication. Willing to switch brand of medication for 4 months or currently taking Asacol or Asacol HD.\n* Has not taken steroid medication within the previous 3 months. Is able to come to MGH hospital for 6 visits.\n\nExclusion Criteria:\n\n* Is not taking mesalamine medication. Unwilling to switch brand of medication for 4 months.\n* Is or has taken steroid medication within the past 3 months. Is unable to come to MGH hospital for 6 visits.\n* Has had a vasectomy or has documented infertility.'}, 'identificationModule': {'nctId': 'NCT01331551', 'acronym': 'MARS', 'briefTitle': 'Mesalamine and Reproductive Health Study', 'organization': {'class': 'OTHER', 'fullName': 'Harvard School of Public Health (HSPH)'}, 'officialTitle': 'Crossover Study on Human Exposure to Phthalates and Male Fertility', 'orgStudyIdInfo': {'id': '5R01ES17285-2'}, 'secondaryIdInfos': [{'id': '5R01ES017285', 'link': 'https://reporter.nih.gov/quickSearch/5R01ES017285', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'men with inflammatory bowel disease', 'description': 'Men between the ages of 18-55 with inflammatory bowel disease who are taking mesalamine medication.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachuetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Russ B Hauser, MD, ScD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard School of Public Health (HSPH)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Participants may receive semen and hormone analysis if they desire.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, {'name': "Boston Children's Hospital", 'class': 'OTHER'}, {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Russ Hauser', 'investigatorAffiliation': 'Harvard School of Public Health (HSPH)'}}}}