CompletedPhase 1

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

United States24 participantsStarted 2010-07

Plain-language summary

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

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patients must be in a stable, monogamous heterosexual relationship for at least one year.
✓. Patients must have a primary diagnosis of Hypoactive Sexual Desire Disorder for at least six months.
✓. Patients must be naturally postmenopausal women of any age with at least one ovary.
✓. 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.

✕. Patients with a history of drug dependence or abuse within the past twelve months.
✕. Patients who have been previously treated with flibanserin.
✕. 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.
✕. Patients who indicate that their sexual partner has inadequately treated organic or psychosexual dysfunction that could interfere with a patients response to treatment.
✕. Patients whose sexual function was impaired, in the investigators opinion, by abdominal or vaginal hysterectomy, oophorectomy or any other pelvic, vaginal, or urologic surgery.
✕. 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.
✕. Patients with a history of unexplained vaginal bleeding within the past twelve months.
✕. 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.

Flibanserin: Area Under the Curve; AUC_0-∞

Timeframe: 8 days

Flibanserin: AUC τ,ss

Timeframe: 8 days

Flibanserin: Cmax (Peak Concentration)

Timeframe: 8 days

Flibanserin: Cmax,ss

Timeframe: 8 days

Flibanserin: Tmax,ss

Timeframe: 8 days

NCT IDNCT01188603

SponsorSprout Pharmaceuticals, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-10

Results submitted2011-05-04

Who can participate

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patients must be in a stable, monogamous heterosexual relationship for at least one year.
✓. Patients must have a primary diagnosis of Hypoactive Sexual Desire Disorder for at least six months.
✓. Patients must be naturally postmenopausal women of any age with at least one ovary.
✓. 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.

✕. Patients with a history of drug dependence or abuse within the past twelve months.
✕. Patients who have been previously treated with flibanserin.
✕. 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.
✕. Patients who indicate that their sexual partner has inadequately treated organic or psychosexual dysfunction that could interfere with a patients response to treatment.
✕. Patients whose sexual function was impaired, in the investigators opinion, by abdominal or vaginal hysterectomy, oophorectomy or any other pelvic, vaginal, or urologic surgery.
✕. 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.
✕. Patients with a history of unexplained vaginal bleeding within the past twelve months.
✕. 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.