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

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Sexual Dysfunctions, Psychological	Drug: flibanserin 100 mg dose every evening	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	24 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Evaluation of Single Dose and Steady State Pharmacokinetics of Flibanserin Postmenopausal Women With Hypoactive Sexual Desire Disorder
Study Start Date :	July 2010
Actual Primary Completion Date :	October 2010
Actual Study Completion Date :	October 2010

Arms and Interventions

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Arm	Intervention/treatment
Experimental: flibanserin; flibanserin 100 mg dose every evening	Drug: flibanserin 100 mg dose every evening; all subjects receive flibanserin

Outcome Measures

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Primary Outcome Measures :

1. Flibanserin: Area Under the Curve; AUC_0-∞ [ Time Frame: 8 days ]
   Geometric mean of the AUC_0-∞ of Flibanserin
2. Flibanserin: AUC τ,ss [ Time Frame: 8 days ]
   Geometric mean of the AUC τ,ss of Flibanserin
3. Flibanserin: Cmax (Peak Concentration) [ Time Frame: 8 days ]
   Geometric mean of the Cmax of Flibanserin
4. Flibanserin: Cmax,ss [ Time Frame: 8 days ]
   Geometric mean of the Cmax,ss of Flibanserin
5. Flibanserin: Tmax,ss [ Time Frame: 8 days ]
   Median of the tmax,ss of Flibanserin

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.
11. Patients with a history of dementia or other neurodegenerative disease; organic brain disease; stroke; transient ischemic attacks; multiple sclerosis; spinal cord injury; brain surgery; significant brain trauma; peripheral neuropathy; and epilepsy.
12. Patients with ongoing hepatic impairment (cirrhosis, hepatic tumor, or other hepatic disease); peptic ulcer within six months prior to Screening; elevated liver enzymes ; inflammatory bowel disease; gastrointestinal bleeding within two months prior to Screening; Patients who have had bariatric surgery for obesity.
13. Patients with a history of angina; atherosclerotic cardiovascular disease; congestive heart failure; cardiomyopathy; symptomatic cardiac valve disease; arrhythmia; hypertension.
14. Patients with a history of renal failure; known history of chronic glomerulonephritis.
15. Patients with a history of chronic obstructive pulmonary disease, chronic bronchitis, or asthma not well controlled with medication taken twice daily or less.
16. Patients with a history of gonadotrophic hormone disorders or uncontrolled diabetes mellitus.
17. Uncorrected hypothyroidism or hyperthyroidism.
18. Patients with a history of uncontrolled glaucoma.
19. Patients with known Human Immunodeficiency Virus infection, Acquired Immunodeficiency Syndrome, other clinically significant immunological disorders or auto-immune disorders such as lupus or scleroderma.
20. Patients with a history of any cancer within the past ten years, other than non-invasive, previously resected basal cell carcinoma of the skin.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Florida
511.146.01003 Boehringer Ingelheim Investigational Site
Orlando, Florida, United States
United States, Kansas
511.146.01005 Boehringer Ingelheim Investigational Site
Wichita, Kansas, United States
United States, Michigan
511.146.01001 Boehringer Ingelheim Investigational Site
Kalamazoo, Michigan, United States
United States, Tennessee
511.146.01004 Boehringer Ingelheim Investigational Site
Knoxville, Tennessee, United States

Sponsors and Collaborators

Sprout Pharmaceuticals, Inc

Investigators

Study Chair:	Sprout Pharmaceuticals	Sprout Pharmaceuticals

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Sprout Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:	NCT01188603 History of Changes
Other Study ID Numbers:	511.146
First Posted:	August 25, 2010
Results First Posted:	April 10, 2012
Last Update Posted:	May 21, 2014
Last Verified:	May 2014

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological; Mental Disorders