Sexual Dysfunctions, Psychological
Conditions
Brief summary
To estimate the duration of efficacy with continued treatment of double-blind flibanserin or placebo over twenty-four weeks of treatment.
Interventions
DRUGFlibanserin
flibanserin flexible dosing
Sponsors
Sprout Pharmaceuticals, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Women over 18 and pre-menopausal 2. FSDS-R above 14 3. Willingness to try to have sexual activity at least monthly 4. Willingness to use an electronic diary daily 5. Stable, monogamous, heterosexual relationship for at least one year 6. Medically acceptable method of contraception
Exclusion criteria
1. Clinically relevant conditions which might interfere with the patient's abil ity to participate in the trial 2. Specified medications 3. Sexual function affected by medication 4. Drug dependence or abuse 5. Sexual partner needing treatment 6. Peri-Menopause or Menopause (surgical or otherwise) 7. Pregnancy 8. Pelvic Inflammatory Disease 9. Major depressive Episode 10. Significant ECG abnormalities 11. Significant Neurologic findings 12. Significant GI, Hepatic, Cardiovascular, Renal, Hematologic, Immunologic or Respiratory findings 13. Uncorrected thyroid or endocrine disease 14. Uncontrolled Glaucoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of efficacy of flibanserin in Sexually Satisfying Events | 24 weeks |
Countries
Canada, United States
Outcome results
None listed