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Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00996164
First Posted: October 16, 2009
Last Update Posted: May 19, 2014
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.
Information provided by (Responsible Party):
Sprout Pharmaceuticals, Inc
October 15, 2009
October 16, 2009
March 11, 2014
May 19, 2014
May 19, 2014
October 2009
December 2010   (Final data collection date for primary outcome measure)
  • The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain. [ Time Frame: 24 weeks ]
    The FSFI is a self-administered questionnaire for assessing key dimensions of sexual function in women. The scale consists of 19 items assessing sexual function over the past 4 weeks and yields scores in 6 domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The 2 items in the desire domain are scored from '1' to '5'. The raw scores of the 2 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 to 6.0. The higher the score on the desire domain, the higher the level of reported sexual desire.
  • Change From Baseline in the SSE Count From Baseline to 24 Weeks [ Time Frame: 24 weeks ]

    The change from baseline in the number of Satisfying Sexual Events (SSEs) as measured by the eDiary. The 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.

    An eDiary was used by the patients to record information about sexual events. Patients were instructed to complete the eDiary every morning. When completing an eDiary entry, patients answered questions regarding their sexual events since their last eDiary entry. If patients missed or were late with their eDiary entry, they entered information about their sexual events covering a maximum time period of the past 7 days; however, they did not enter any information beyond the last entry.

The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain. [ Time Frame: 24 weeks ]
Complete list of historical versions of study NCT00996164 on ClinicalTrials.gov Archive Site
Not Provided
Change from baseline in the number of SSE as measured by the eDiary; Change from baseline in the SSE count; Change from baseline to week 24 on the FSFI total score; Change from baseline to Week 24 on Question 13 of the FSDS R [ Time Frame: 24 weeks ]
Not Provided
Not Provided
 
Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder
A Twenty-four Week, Randomized, Double-blind, Placebo Controlled, Safety and Efficacy Trial of Flibanserin (100 Milligrams) Administered Orally Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder in the United States
The object of this trial is to assess the safety and efficacy of a 24 week course of flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Sexual Dysfunctions, Psychological
  • 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
  • Experimental: flibanserin 100 mg
    flibanserin 100mg po qd
    Intervention: Drug: Flibanserin
  • Placebo Comparator: Placebo
    placebo 1 tab po qd
    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.
 
Completed
1090
February 2011
December 2010   (Final data collection date for primary outcome measure)

Inclusion criteria:

  1. Premenopausal women who are 18 years old and older
  2. Primary diagnosis of hypoactive sexual desire disorder, generalized acquired type according to Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision, at least 24 weeks in duration.
  3. Stable, monogamous heterosexual relationship for at least one year.
  4. Willing to discuss sexual issues.
  5. Willing to engage in sexual activity at least once a month
  6. Normal pap smear
  7. Must use medically acceptable method of contraception
  8. Able to comply with daily use of a handheld entry device

Exclusion criteria:

  1. Patients who have taken any medication in the protocol List of Prohibited Medications within 30 days before the screening visit.
  2. Patients who meet Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision for: Sexual aversion disorder, substance induced sexual dysfunction, Dyspareunia, vaginismus, gender identity disorder, paraphilia, sexual dysfunction do to a general medical condition.
  3. Partner with inadequately treated organic or psychosexual dysfunction
  4. History of Major Depressive Disorder within six months prior to the screening visit or history of suicidal behavior.
  5. Sexual function impaired by psychiatric disorder
  6. Sexual function impaired by gynecological disorder
  7. Major life stress that could impair sexual function
  8. Substance abuse
Sexes Eligible for Study: Female
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00996164
511.147
Yes
Not Provided
Not Provided
Sprout Pharmaceuticals, Inc
Sprout Pharmaceuticals, Inc
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Sprout Pharmaceuticals, Inc
April 2014

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