Ignite Creation Date:
2025-12-24 @ 12:32 PM
Ignite Modification Date:
2025-12-30 @ 9:29 AM
Study NCT ID:
NCT04002661
Status:
RECRUITING
Last Update Posted:
2025-02-14
First Post:
2019-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypoactive Sexual Desire Disorder in Males
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C098107', 'term': 'flibanserin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Study medication (flibanserin 100 mg or identically matched placebo) will be provided in a randomized fashion. Randomization will be 1:1 with a block size of 4. Each individual kit will contain three bottles of 30 tablets of study medication. Each individual bottle within the kit will be labeled sequentially, for example kit 201 will include three bottles of 30 tablets labeled 201A, 201B, 201C. Kits will be numbered consecutively in the randomized order. Once a patient is confirmed eligible to participate in the study, the site will select the lowest numbered kit that has not been assigned to a subject. Subjects will be provided with the "A" bottle at their first visit. The site will mark the subject\'s study number on the kit and document which subject received that kit number. As subjects return for interim visits, they will be provided the "B" and "C" bottles from their previously assigned kit.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Arm 1 will receive investigational product.\n\nArm 2 will receive placebo.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-13', 'studyFirstSubmitDate': '2019-04-24', 'studyFirstSubmitQcDate': '2019-06-27', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sexual Desires Inventory-2 (SDI-2)', 'timeFrame': '3 months', 'description': 'Range 2-10: Number of Participants with a significant change of at least 2 points higher than at screening.'}, {'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': '3 months', 'description': 'Number of Participant with a significant change of at least 2 points on the PHQ-2 questionnaire after 3 months'}], 'secondaryOutcomes': [{'measure': 'Erectile Function Change', 'timeFrame': '3 months', 'description': 'Number of Participants with a significant change in erectile function and orgasmic scores of at least 2 points on the International Index of Erectile Function (Questions 2, 11, and 12) domain is considered to be 2 points higher than at screening'}, {'measure': 'Sexual Concerns Inventory - Male (SCI-M) questionnaire', 'timeFrame': '3 months', 'description': 'Number of Participants with a significant change of at least 2 points higher than at screening.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low libido', 'Erectile Dysfunction', 'Sexual desire'], 'conditions': ['Low Libido']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the study drug will increase sexual desire in men with HSDD. Half of the participants will take ADDYI while the other half will receive a placebo (a look-alike pill with no medicine).', 'detailedDescription': 'This pilot randomized placebo controlled study will include 60 men (30 treatment and 30 placebo). ARM 1 will take flibanserin 100mg orally every night and ARM 2 will take a placebo orally every night.\n\nThere will be four study visits and the study duration is approximately 4 months. Participants will have physicals at each visit. Blood draws for tests will be done at 3 visits and up to 4 questionnaires will completed at each visit. Study drug will randomized.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Men who have a low libido defined by the SDI-2 (Sexual Desires Index-2), and SCI-M (Sexual Conerns Inventory - Male) questionnaires.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men age 18 through 69 years old\n* Men who are distressed by their low libido as defined by SDI-2, and SCI-M questionnaires. (Appendices A,C)\n* Men who are not depressed as defined by PHQ-9 (Patient Health Questionnaire) score of 9 or less. (Appendix D)\n* Men with good erectile function as defined by IIEF greater than 22\n* Men with normal testosterone and liver function values (may be on testosterone therapy)\n* Men who are satisfied in their relationship or with their partners\n* Men or their female partners must be willing to use one form of contraception throughout the study and 30 days after final study visit.\n* Willing to give informed consent\n\nExclusion Criteria:\n\n* Hypogonadal patients (less than 350 ng/dL)\n* IIEF-EF less than 22\n* CYP3A4 and CYP2C19 inhibitors Use of moderate or strong CYP3A4 inhibitors is prohibited for the duration of the trial, and if such medication becomes necessary, flibanserin treatment must be suspended until 2 weeks after the last dose of the CYP3A4 inhibitor\n* Hepatic impairment not greater than 1.5 upper limit of normal of AST/ALT\n* Men with normal to high libido\n* Depressed patients as assessed by the PHQ-9 questionnaire as defined as 10 or greater.\n* Men who are stressed or fatigued as determined by the PI\n* Men with partners who have low libido as determined by the PI\n* Men with pre-existing conditions that might predispose to hypertension\n* Men who are not willing to meet the requirements for drinking alcohol during their participation in the study\n* Men who are taking digoxin'}, 'identificationModule': {'nctId': 'NCT04002661', 'acronym': 'HSDD', 'briefTitle': 'Hypoactive Sexual Desire Disorder in Males', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Hypoactive Sexual Desire Disorder in Males (10-18-40-13)', 'orgStudyIdInfo': {'id': 'H-44634'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1 - Active', 'description': 'Participants will take flibanserin 100mg orally every night for approximately 3 months.', 'interventionNames': ['Drug: Flibanserin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 2 - Placebo', 'description': 'Participants will take a placebo orally every night for approximately 3 months.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Flibanserin', 'type': 'DRUG', 'otherNames': ['Addyi'], 'description': 'Flibanserin tablet', 'armGroupLabels': ['Arm 1 - Active']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral Tablet', 'armGroupLabels': ['Arm 2 - Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Haarika Gudlavalleti', 'role': 'CONTACT', 'email': 'haarika.gudlavalleti@bcm.edu', 'phone': '713-986-4398'}, {'name': 'Tabish Iqbal', 'role': 'CONTACT', 'email': 'tiqbal@bcm.edu', 'phone': '713-798-8514'}, {'name': 'Mohit Khera, MD, MBA, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Larry I. Lipshultz, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Mohit Khera, MD, MBA, MPH', 'role': 'CONTACT', 'email': 'mkhera@bcm.edu', 'phone': '713-798-6593'}, {'name': 'Haarika Gudlavalleti', 'role': 'CONTACT', 'email': 'haarika.gudlavalleti@bcm.edu', 'phone': '713-7984398'}], 'overallOfficials': [{'name': 'Mohit Khera, MD, MBA, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'De-identified individual participant date for all primary and secondary outcome measures will be made available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mohit Khera', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sprout Pharmaceuticals, Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Urology', 'investigatorFullName': 'Mohit Khera', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}