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

NCT01188603 | Completed Phase 1 Results

• 1 other identifier: 511.146
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Sexual Dysfunctions, Psychological

Outcome Measures

Primary Outcomes (5)

• Flibanserin: Area Under the Curve; AUC_0-∞

  Geometric mean of the AUC\_0-∞ of Flibanserin

  8 days

• Flibanserin: AUC τ,ss

  Geometric mean of the AUC τ,ss of Flibanserin

  8 days

• Flibanserin: Cmax (Peak Concentration)

  Geometric mean of the Cmax of Flibanserin

  8 days

• Flibanserin: Cmax,ss

  Geometric mean of the Cmax,ss of Flibanserin

  8 days

• Flibanserin: Tmax,ss

  Median of the tmax,ss of Flibanserin

  8 days

Study Arms (1)

flibanserin

EXPERIMENTAL

flibanserin 100 mg dose every evening

Drug: flibanserin 100 mg dose every evening

Interventions

flibanserin 100 mg dose every evening DRUG

all subjects receive flibanserin

flibanserin

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Clinically significant electrocardiogram abnormalities at Screening.
• 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.
• 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.
• Patients with a history of angina; atherosclerotic cardiovascular disease; congestive heart failure; cardiomyopathy; symptomatic cardiac valve disease; arrhythmia; hypertension.
• Patients with a history of renal failure; known history of chronic glomerulonephritis.
• Patients with a history of chronic obstructive pulmonary disease, chronic bronchitis, or asthma not well controlled with medication taken twice daily or less.

Sponsors & Collaborators

• Sprout Pharmaceuticals, Inc: lead

Study Sites (4)

511.146.01003 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Location

511.146.01005 Boehringer Ingelheim Investigational Site

Wichita, Kansas, United States

Location

511.146.01001 Boehringer Ingelheim Investigational Site

Kalamazoo, Michigan, United States

Location

511.146.01004 Boehringer Ingelheim Investigational Site

Knoxville, Tennessee, United States

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Interventions

flibanserin

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Sprout Pharmaceuticals
• Organization: Sprout Pharmaceuticals

clinicaltrials@sproutpharma.com

1-919-882-0850

Study Officials

• Sprout Pharmaceuticals

  Sprout Pharmaceuticals

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2010
• First Posted: August 25, 2010
• Study Start: July 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: May 21, 2014
• Results First Posted: April 10, 2012

Record last verified: 2014-05

Locations

US (4)