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

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. Identifier: NCT00996164
Recruitment Status : Completed
First Posted : October 16, 2009
Results First Posted : May 19, 2014
Last Update Posted : May 19, 2014
Information provided by (Responsible Party):
Sprout Pharmaceuticals, Inc

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sexual Dysfunctions, Psychological Drug: Flibanserin Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1090 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Flibanserin

Arm Intervention/treatment
Experimental: flibanserin 100 mg
flibanserin 100mg po qd
Drug: Flibanserin
patients will be randomized to flibanserin or placebo in a double-blind manner

Placebo Comparator: Placebo
placebo 1 tab po qd
Drug: Placebo
patients will be randomized to flibanserin or placebo in a double-blind manner

Primary Outcome Measures :
  1. 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.

  2. 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.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00996164

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Sponsors and Collaborators
Sprout Pharmaceuticals, Inc
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Sprout Pharmaceuticals, Inc Identifier: NCT00996164     History of Changes
Other Study ID Numbers: 511.147
First Posted: October 16, 2009    Key Record Dates
Results First Posted: May 19, 2014
Last Update Posted: May 19, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Mental Disorders