Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy

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

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.

Study Overview

• Status: Terminated
• Conditions: Hypoactive Sexual Desire Disorder
• Intervention / Treatment: Drug: flibanserin; Behavioral: sex therapy

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92120
      • San Diego Sexual Medicine

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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	Drug: flibanserin; FDA approved medication for treatment of hypoactive sexual desire disorder in premenopausal women; Other Names: Addyi; Behavioral: sex therapy; 60 minutes each time, in person or on the telephone; Other Names: psychotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Desire domain of the Female Sexual Function Index (FSFI)	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.	at weeks 8 and 20

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Female Sexual Distress Scale (FSDS-DAO)	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.	at weeks 8 and 20
Total score of the Female Sexual Function Index (FSFI)	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.	at weeks 8 and 20

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Global Impression of Improvement (PGI-I)	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.	at weeks 8 and 20

Collaborators and Investigators

• Sponsor: San Diego Sexual Medicine

Publications and helpful links

Helpful Links

• Clinical trials at San Diego Sexual Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2017
• Primary Completion (Actual): January 18, 2019
• Study Completion (Actual): January 30, 2019

Study Registration Dates

• First Submitted: March 11, 2016
• First Submitted That Met QC Criteria: March 15, 2016
• First Posted (Estimate): March 21, 2016

Study Record Updates

• Last Update Posted (Actual): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 8, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: HSDD; hypoactive sexual desire disorder; Addyi; flibanserin; low sexual desire
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Hypokinesia; Sexual Dysfunctions, Psychological
• Other Study ID Numbers: SDSM-2015-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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