Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy
NCT02714049 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 23
Last updated 2022-06-13
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.
Conditions
- Hypoactive Sexual Desire Disorder
Interventions
- 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
Sponsors & Collaborators
-
San Diego Sexual Medicine
lead OTHER
Principal Investigators
-
Irwin Goldstein, MD · San Diego Sexual Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-01-25
- Primary Completion
- 2019-01-18
- Completion
- 2019-01-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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