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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Sprout Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01057901
First received: January 25, 2010
Last updated: March 14, 2012
Last verified: March 2012
History of Changes
  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 - Week Flibanserin 100mg for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in Noth America

Resource links provided by NLM:

U.S. FDA Resources

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: 748
Study Start Date: January 2010
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Flibanserin 100 mg
Flibanserin 100 mg administered at bedtime
 Drug: Flibanserin
Flibanserin 100mg administered at bedtime for 24 weeks
Placebo Comparator: Placebo
This is the matched placebo which will be administered two tablets daily at bedtime.
 Drug: Placebo
This is the matched placebo which will be administered two tablets daily at bedtime.

  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: NCT01057901

  Show 100 Study Locations
Sponsors and Collaborators
Sprout Pharmaceuticals, Inc
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Sprout Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01057901     History of Changes
Other Study ID Numbers: 511.156
Study First Received: January 25, 2010
Last Updated: March 14, 2012
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Hypokinesia
Sexual and Gender Disorders
Mental Disorders
 Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013