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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01057901
Recruitment Status : Terminated (Study terminated for administrative reasons.)
First Posted : January 28, 2010
Results First Posted : June 17, 2014
Last Update Posted : June 17, 2014
Sponsor:
Information provided by (Responsible Party):
Sprout Pharmaceuticals, Inc

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Sexual Dysfunctions, Psychological Drug: Flibanserin Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 748 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 24 - Week Flibanserin 100mg for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in Noth America
Study Start Date : January 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Flibanserin

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in the Number of Satisfying Sexual Events [ Time Frame: baseline to 24 weeks ]

    The change from baseline in the number of SSE's as measured by the eDiary. The calculation of Satisfying Sexual Event (SSEs) will be standardized to a 28-day period according to the below formula:

    Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered).

    "Satisfying" means gratifying, fulfilling, satisfactory, and/or successful for the patient. The partner's satisfaction is not the subject of this question.


  2. Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain [ Time Frame: baseline to 24 weeks ]
    The Female Sexual Function Index (FSFI) is a brief, multidimensional, self-administered questionnaire for assessing key domains of sexual function in women. The scale consists of 19 items that assess sexual function over the past four weeks and yields scores in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The two items in the desire domain are scored from 1 to 5 (1 is lowest level of desire and 5 is the highest level of desire). The raw scores of the two items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 (lowest level of desire) to 6.0 (highest level of desire). For the entire instrument, each of the six domains contributes a maximum of 6 points to the total. Scores on the full scale range from a minimum of 2 to a maximum of 36.


Eligibility Criteria
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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01057901


Locations
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Sponsors and Collaborators
Sprout Pharmaceuticals, Inc
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sprout Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01057901    
Other Study ID Numbers: 511.156
First Posted: January 28, 2010    Key Record Dates
Results First Posted: June 17, 2014
Last Update Posted: June 17, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Sexual Dysfunctions, Psychological
Mental Disorders