Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy
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ClinicalTrials.gov Identifier: NCT02714049 |
Recruitment Status :
Terminated
(Investor Initiated Grant support stopped when drug was sold.)
First Posted : March 21, 2016
Last Update Posted : October 3, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypoactive Sexual Desire Disorder | Behavioral: sex therapy Drug: flibanserin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 23 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Two Arm Open Label Pilot Study of Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy |
Actual Study Start Date : | January 25, 2017 |
Actual Primary Completion Date : | January 18, 2019 |
Actual Study Completion Date : | January 30, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: flibanserin
Subjects meeting inclusion/exclusion criteria who respond to flibanserin will have a total of 20 weeks of open label drug
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Drug: flibanserin
FDA approved medication for treatment of hypoactive sexual desire disorder in premenopausal women
Other Name: Addyi |
Experimental: flibanserin and sex therapy
Subjects meeting inclusion/exclusion criteria who respond to flibanserin will have a total of 20 weeks of open label drug as well as 9 sex therapy visits
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Behavioral: sex therapy
60 minutes each time, in person or on the telephone
Other Name: psychotherapy Drug: flibanserin FDA approved medication for treatment of hypoactive sexual desire disorder in premenopausal women
Other Name: Addyi |
- Desire domain of the Female Sexual Function Index (FSFI) [ Time Frame: at weeks 8 and 20 ]The primary objective of this study is to determine whether efficacy of flibanserin as determined by changes in the desire domain of the Female Sexual Function Index (FSFI) in women who respond to the study medication is greater when sex therapy is performed concomitant with the use of the medication.
- Female Sexual Distress Scale (FSDS-DAO) [ Time Frame: at weeks 8 and 20 ]One secondary endpoint is to determine whether efficacy of flibanserin as determined by changes from baseline in the Female Sexual Distress Scale (FSDS-DAO) in women who respond to the study medication.
- Total score of the Female Sexual Function Index (FSFI) [ Time Frame: at weeks 8 and 20 ]One secondary endpoint is to determine whether efficacy of flibanserin as determined by changes from baseline in the total FSFI score respectively in women who respond to the study medication.
- Patient Global Impression of Improvement (PGI-I) [ Time Frame: at weeks 8 and 20 ]The last goal is to identify those women with primary biologic based HSDD who respond to flibanserin and determine whether or not they feel concomitant sex therapy might be more beneficial.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subject is willing and able to provide written informed consent and HIPAA authorization before any study procedures are conducted;
- Subject is female;
- Subject is ≥18 years old;
- Subject has biologic-based HSDD as her primary sexual complaint;
- Subject scores <26 on FSFI and <4.8 on desire domain of FSFI at screening;
- Subject scores >18 on FSDS-DAO;
- Subject answers yes to questions 1-4 on the DSDS screener;
- Subject is willing to use effective contraception during the study if pre-menopausal (oral contraceptives, barrier method, long acting reversible contraceptive, surgical sterilization);
- Subject agrees to comply with the study procedures and visits.
Exclusion Criteria:
- Subject has sexual pain;
- Subject does not have generalized, acquired HSDD;
- Subject has used flibanserin in the last 6 months;
- Subject has history of alcohol or drug abuse;
- Subject uses tobacco in any form;
- Subject is currently using androgen therapy and unwilling to washout;
- Subject is pregnant, nursing, or planning to become pregnant over the next 6 months;
- Subject is taking a moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitor;
- Subject is taking a CYP3A4 inducer;
- P-glycoprotein substrate;
- Subject has a history of liver impairment;
- Subject has any chronic medical condition or psychologic disorder that the Principal Investigator feels makes her ineligible for the study;
- Subject has any condition or exhibits behavior that indicates to the Principal Investigator that the Subject is unlikely to be compliant with study procedures and visits.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714049
United States, California | |
San Diego Sexual Medicine | |
San Diego, California, United States, 92120 |
Principal Investigator: | Irwin Goldstein, MD | San Diego Sexual Medicine |
Responsible Party: | San Diego Sexual Medicine |
ClinicalTrials.gov Identifier: | NCT02714049 |
Other Study ID Numbers: |
SDSM-2015-03 |
First Posted: | March 21, 2016 Key Record Dates |
Last Update Posted: | October 3, 2019 |
Last Verified: | January 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
hypoactive sexual desire disorder Addyi flibanserin low sexual desire HSDD |
Hypokinesia Sexual Dysfunctions, Psychological Dyskinesias |
Neurologic Manifestations Nervous System Diseases Mental Disorders |