Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sprout Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00996372
First received: October 15, 2009
Last updated: March 2, 2012
Last verified: March 2012
  Purpose

The objective of this trial is to assess the safety and efficacy of 24-week course of flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in naturally postmenopausal women.


Condition Intervention Phase
Sexual Dysfunctions, Psychological
Drug: flibanserin
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 24-wk Efficacy and Safety of Flibanserin vs Pbo in Naturally Postmenopausal Women in United States

Resource links provided by NLM:


Further study details as provided by Sprout Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Change from baseline in the number of satisfying sexual events [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the score on the Female Sexual Function Index (FSFI) desire domain [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline on Question 13 of the Female Sexual Distress Scale Revised (FSDS R) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline on FSDS R total score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline on FSFI total score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Score on Patient Global Impression of Improvement [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 949
Study Start Date: October 2009
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: flibanserin 100mg
flibanserin 100mg po qd
Drug: flibanserin
patients will be randomized to flibanserin or placebo in a double-blind manner
Drug: placebo
patients will be randomized to flibanserin or placebo in a double-blind manner
Placebo Comparator: placebo
placebo one tablet po qd
Drug: placebo
patients will be randomized to flibanserin or placebo in a double-blind manner

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Naturally postmenopausal women of any age with at least one ovary
  • Diagnosis of Hypoactive Sexual Desire Disorder, generalized acquired type,of at least six months duration
  • Stable, monogamous heterosexual relationship for at least one year
  • Willing to discuss sexual issues
  • Willing to engage in sexual activity at least once a month
  • Normal Pap smear
  • Normal mammogram
  • Normal uterine lining
  • Able to comply with daily use of handheld data entry device

Exclusion criteria:

  • Sexual dysfunctions other than HSDD, such as Sexual Aversion Disorder, Substance-induced Sexual Dysfunction, Dyspareunia, Vaginismus, Gender Identity Disorder, Paraphilia and Sexual Dysfunction due to a General Medical Condition
  • Partner with inadequately treated organic or psychosexual dysfunction
  • Sexual function impaired by psychiatric disorder
  • Sexual function impaired by gynecological disorder
  • Major Depression
  • Suicidal behavior or ideation
  • Major life stress that could impair sexual function
  • Substance abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00996372

  Show 75 Study Locations
Sponsors and Collaborators
Sprout Pharmaceuticals, Inc
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Sprout Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00996372     History of Changes
Other Study ID Numbers: 511.130
Study First Received: October 15, 2009
Last Updated: March 2, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014