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Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy | Clinical Trials | Clareo Health

TERMINATEDPHASE4

Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy

Two Arm Open Label Pilot Study of Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy

NCT02714049•San Diego Sexual Medicine

Summary

Unblinded study of flibanserin for 8 weeks with responders randomized 1:1 to receive study medication alone vs. study medication and sex therapy for 12 additional weeks.

Detailed Description

This is an unblinded study to be conducted at a single research center, San Diego Sexual Medicine. Subjects meeting inclusion and exclusion criteria will receive flibanserin for an 8-week run-in period to differentiate between responders and non-responders. Responders will be determined by a score of 1-3 on the Patient Global Impression of Improvement (PGI-I) at 8 weeks from baseline, and will be randomized 1:1 to receive study medication alone vs. study medication and sex therapy for an additional 12 weeks.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Subject is willing and able to provide written informed consent and HIPAA authorization before any study procedures are conducted;
•2. Subject is female;
•3. Subject is ≥18 years old;
•4. Subject has biologic-based HSDD as her primary sexual complaint;
•5. Subject scores \<26 on FSFI and \<4.8 on desire domain of FSFI at screening;
•6. Subject scores \>18 on FSDS-DAO;
•7. Subject answers yes to questions 1-4 on the DSDS screener;
•8. Subject is willing to use effective contraception during the study if pre-menopausal (oral contraceptives, barrier method, long acting reversible contraceptive, surgical sterilization);
•9. Subject agrees to comply with the study procedures and visits.

Exclusion Criteria

•1. Subject has sexual pain;
•2. Subject does not have generalized, acquired HSDD;
•3. Subject has used flibanserin in the last 6 months;
•4. Subject has history of alcohol or drug abuse;
•5. Subject uses tobacco in any form;
•6. Subject is currently using androgen therapy and unwilling to washout;
•7. Subject is pregnant, nursing, or planning to become pregnant over the next 6 months;
•8. Subject is taking a moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitor;
•9. Subject is taking a CYP3A4 inducer;
•10. P-glycoprotein substrate;
+3 more criteria

Locations (1)

San Diego Sexual Medicine

San Diego, California, United States

Key Dates

Start Date

January 25, 2017

Primary Completion Date

January 18, 2019

Completion Date

January 30, 2019

Last Updated

June 13, 2022

Enrollment

ACTUAL participants

Conditions

Hypoactive Sexual Desire Disorder

Interventions

sex therapy

BEHAVIORAL

flibanserin

DRUG

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COMPLETEDPHASE1/PHASE2

Phase 1b/2a Unblinded Study of Responses in Premenopausal Women With HSDD to Lorexys Evaluating Efficacy and Safety

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 13, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy

Inclusion Criteria

Exclusion Criteria

Bupropion in Sexual Dysfunction Among Methadone Maintenance Treatment Men

Phase 1b/2a Unblinded Study of Responses in Premenopausal Women With HSDD to Lorexys Evaluating Efficacy and Safety

Sexual Dysfunction and Dental Care