Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy

NCT ID: NCT02714049

Last Updated: 2022-06-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-25
• Study Completion Date: 2019-01-30

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.

Conditions

Hypoactive Sexual Desire Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

flibanserin

Subjects meeting inclusion/exclusion criteria who respond to flibanserin will have a total of 20 weeks of open label drug

Group Type: EXPERIMENTAL

flibanserin

Intervention Type: DRUG

FDA approved medication for treatment of hypoactive sexual desire disorder in premenopausal women

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

Group Type: EXPERIMENTAL

sex therapy

Intervention Type: BEHAVIORAL

60 minutes each time, in person or on the telephone

flibanserin

Intervention Type: DRUG

FDA approved medication for treatment of hypoactive sexual desire disorder in premenopausal women

Interventions

sex therapy

60 minutes each time, in person or on the telephone

Intervention Type: BEHAVIORAL

flibanserin

FDA approved medication for treatment of hypoactive sexual desire disorder in premenopausal women

Intervention Type: DRUG

Other Intervention Names

psychotherapy; Addyi

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

San Diego Sexual Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Irwin Goldstein, MD

Role: PRINCIPAL_INVESTIGATOR

San Diego Sexual Medicine

Locations

San Diego Sexual Medicine

San Diego, California, United States

Countries

United States

Related Links

https://www.sandiegosexualmedicine.com/clinical-trials

Clinical trials at San Diego Sexual Medicine

Other Identifiers

SDSM-2015-03

Identifier Type: -

Identifier Source: org_study_id