Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy

• ClinicalTrials.gov Identifier: NCT02714049
• Recruitment Status: Terminated
• First Posted: March 21, 2016
• Last Update Posted: October 3, 2019
• Sponsor: San Diego Sexual Medicine
• Information provided by (Responsible Party): San Diego Sexual Medicine

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypoactive Sexual Desire Disorder	Behavioral: sex therapy; Drug: flibanserin	Phase 4

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 (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

Arms and Interventions

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	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	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

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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.
2. 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.

Other Outcome Measures:

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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;
11. Subject has a history of liver impairment;
12. Subject has any chronic medical condition or psychologic disorder that the Principal Investigator feels makes her ineligible for the study;
13. 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.

Contacts and Locations

Locations

United States, California

San Diego Sexual Medicine

San Diego, California, United States, 92120

Sponsors and Collaborators

San Diego Sexual Medicine

Investigators

• Principal Investigator: Irwin Goldstein, MD; San Diego Sexual Medicine

More Information

• Responsible Party: San Diego Sexual Medicine
• ClinicalTrials.gov Identifier: NCT02714049
• Other Study ID Numbers: SDSM-2015-03
• First Posted: March 21, 2016
• 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

Keywords provided by San Diego Sexual Medicine:

hypoactive sexual desire disorder; Addyi; flibanserin; low sexual desire; HSDD

Additional relevant MeSH terms:

Hypokinesia; Sexual Dysfunctions, Psychological; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Mental Disorders