Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy

Hypoactive Sexual Desire Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02714049
• Other study ID #: SDSM-2015-03
• Status: Terminated
• Phase: Phase 4
• Start date: January 25, 2017
• Est. completion date: January 30, 2019

Study information

• Verified date: June 2022
• Source: San Diego Sexual Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: January 30, 2019
• Est. primary completion date: January 18, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypoactive Sexual Desire Disorder
• Hypokinesia
• Sexual Dysfunctions, Psychological

Intervention

Behavioral:
• sex therapy
60 minutes each time, in person or on the telephone

Drug:
• flibanserin
FDA approved medication for treatment of hypoactive sexual desire disorder in premenopausal women

Locations

Country	Name	City	State
United States	San Diego Sexual Medicine	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
San Diego Sexual Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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

External Links

•   Clinical trials at San Diego Sexual Medicine