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Flibanserin Randomized Withdrawal Trial in Pre-menopausal Women

NCT00277914·65 sites·ClinicalTrials.gov

What this study is about

Take this into the appointment.

Saves the questions and what to expect into your notes, next to the visit they belong to.

Keep this study

Lead

Sprout Pharmaceuticals, Inc

Age

18–45

Sex

FEMALE

Healthy volunteers

Not accepted

You may be eligible if

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

You may not be if

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

The record

StatusCompleted

PhasePhase 3

Taking part749

StartedJan 2006

UpdatedMar 16, 2012

Conditions

Sexual Dysfunctions, Psychological

Where65

511.74.01051 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
511.74.01027 Boehringer Ingelheim Investigational Site
Mobile, Alabama, United States
511.74.01029 Boehringer Ingelheim Investigational Site
Scottsdale, Arizona, United States

Clareo Health | Flibanserin Randomized Withdrawal Trial in Pre-menopausal Women