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Pharmacokinetics of Flibanserin in Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD) | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Pharmacokinetics of Flibanserin in Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD)

Evaluation of Single Dose and Steady State Pharmacokinetics of Flibanserin Postmenopausal Women With Hypoactive Sexual Desire Disorder

NCT01188603•Sprout Pharmaceuticals, Inc

View on ClinicalTrials.gov

Summary

This trial examines the way flibanserin is metabolized in postmenopausal women with Hypoactive Sexual Desire Disorder.

Eligibility

Age

All ages

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Patients must be in a stable, monogamous heterosexual relationship for at least one year.
•2. Patients must have a primary diagnosis of Hypoactive Sexual Desire Disorder for at least six months.
•3. Patients must be naturally postmenopausal women of any age with at least one ovary.
•4. Patients may participate whether or not they are currently taking systemic hormone therapy provided the therapy was not prescribed for treatment of low sexual desire. Hormone therapy must be at a stable dose for at least six months.

Exclusion Criteria

•1. Patients with a history of drug dependence or abuse within the past twelve months.
•2. Patients who have been previously treated with flibanserin.
•3. Patients who have sexual dysfunctions other than Hypoactive Sexual Desire Disorder, such as: Sexual Aversion Disorder, Substance-Induced Sexual Dysfunction, Dyspareunia, Vaginismus, Gender Identity Disorder,Paraphilia, or Sexual Dysfunction due to a general medical condition.
•4. Patients who indicate that their sexual partner has inadequately treated organic or psychosexual dysfunction that could interfere with a patients response to treatment.
•5. Patients whose sexual function was impaired, in the investigators opinion, by abdominal or vaginal hysterectomy, oophorectomy or any other pelvic, vaginal, or urologic surgery.
•6. Patients with pelvic pain, pelvic inflammatory disease, endometriosis, urinary tract or vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, symptomatic vaginal atrophy or any other gynecological pathology requiring further evaluation.
•7. Patients with a history of unexplained vaginal bleeding within the past twelve months.
•8. Patients with a history of Major Depressive Disorder within six months prior to Screening; ; active suicidal ideation with intent in the past ten years or suicidal behavior at any time.
•9. Patients with a history of any other psychiatric disorder that could impact sexual function, increase risks to patient safety, or impair patient compliance. Such disorders include but are not limited to bipolar disorder, psychotic disorders, severe anxiety, eating disorders, and antisocial personality disorders.
•10. Clinically significant electrocardiogram abnormalities at Screening.
+10 more criteria

Locations (4)

511.146.01003 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

511.146.01005 Boehringer Ingelheim Investigational Site

Wichita, Kansas, United States

511.146.01001 Boehringer Ingelheim Investigational Site

Kalamazoo, Michigan, United States

511.146.01004 Boehringer Ingelheim Investigational Site

Knoxville, Tennessee, United States

Key Dates

Start Date

July 1, 2010

Primary Completion Date

October 1, 2010

Completion Date

October 1, 2010

Last Updated

May 21, 2014

Enrollment

ACTUAL participants

Conditions

Sexual Dysfunctions, Psychological

Interventions

flibanserin 100 mg dose every evening

DRUG

Sexual Function Changes in High-Risk Pregnancies

NCT05093647

Sexual Dysfunctions, PsychologicalHigh Risk Pregnancy+1 more

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COMPLETEDPHASE2

Bupropion in Sexual Dysfunction Among Methadone Maintenance Treatment Men

NCT02593396

Sexual Dysfunctions, PsychologicalHypoactive Sexual Desire Disorder+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 21, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pharmacokinetics of Flibanserin in Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD)

Inclusion Criteria

Exclusion Criteria

Sexual Function Changes in High-Risk Pregnancies

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Uptitration Trial of Flibanserin Versus Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder

Sexual Health on Antidepressants Through Physical Exercise

A One-year Safety Study of Flibanserin to Treat Pre-Menopausal Women With Hypoactive Sexual Desire Disorder (HSDD).

Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder