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

January 25, 2010
March 14, 2012
January 2010
January 2011   (final data collection date for primary outcome measure)
  • 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 ]
Change from baseline in the number of satisfying sexual events Change from baseline in the score on the Female Sexual Function Index (FSFI) desire domain [ Time Frame: 24 weeks ]
Complete list of historical versions of study NCT01057901 on ClinicalTrials.gov Archive Site
  • 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 ]
Change from baseline on Question 13 of the Female Sexual Distress Scale Revised (FSDS R) Change from baseline on FSDS R total score Change from baseline on FSFI total score Score on Patient Global Impression of Improvement [ Time Frame: 24 weeks ]
Not Provided
Not Provided
 
Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in North America
24 - Week Flibanserin 100mg for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in Noth America

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Sexual Dysfunctions, Psychological
  • Drug: Flibanserin
    Flibanserin 100mg administered at bedtime for 24 weeks
  • Drug: Placebo
    This is the matched placebo which will be administered two tablets daily at bedtime.
  • Active Comparator: Flibanserin 100 mg
    Flibanserin 100 mg administered at bedtime
    Intervention: Drug: Flibanserin
  • Placebo Comparator: Placebo
    This is the matched placebo which will be administered two tablets daily at bedtime.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
748
Not Provided
January 2011   (final data collection date for primary outcome measure)

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
Female
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01057901
511.156
Not Provided
Sprout Pharmaceuticals, Inc
Sprout Pharmaceuticals, Inc
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Sprout Pharmaceuticals, Inc
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP