Two Arm Open Label Pilot Study of Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Desire domain of the Female Sexual Function Index (FSFI)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
flibanserin
Subjects meeting inclusion/exclusion criteria who respond to flibanserin will have a total of 20 weeks of open label drug
Intervention: flibanserin (Drug)
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
Intervention: sex therapy (Behavioral)
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
Intervention: flibanserin (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Total score of the Female Sexual Function Index (FSFI)(at weeks 8 and 20)
- Female Sexual Distress Scale (FSDS-DAO)(at weeks 8 and 20)