Clinical trial NCT02714049: Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy
Official title: Two Arm Open Label Pilot Study of Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hypoactive Sexual Desire Disorder
Keywords: hypoactive sexual desire disorder
Addyi
flibanserin
low sexual desire
HSDD
Lead sponsor: San Diego Sexual Medicine
Sponsor class: OTHER
First posted: 2016-03-21
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Desire domain of the Female Sexual Function Index (FSFI)
timeFrame: at weeks 8 and 20
Secondary outcomes:
measure: Female Sexual Distress Scale (FSDS-DAO)
timeFrame: at weeks 8 and 20
measure: Total score of the Female Sexual Function Index (FSFI)
timeFrame: at weeks 8 and 20
Other outcomes:
measure: Patient Global Impression of Improvement (PGI-I)
timeFrame: at weeks 8 and 20
Locations:
city: San Diego
country: United States
facility: San Diego Sexual Medicine
state: California
Study officials:
affiliation: San Diego Sexual Medicine
name: Irwin Goldstein, MD
role: PRINCIPAL_INVESTIGATOR
References: