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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sprout Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00996164
First received: October 15, 2009
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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 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: 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

Further study details as provided by Sprout Pharmaceuticals, Inc:

Primary Outcome Measures:
  • The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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.



Enrollment: 1090
Study Start Date: October 2009
Study Completion Date: February 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00996164

  Show 75 Study Locations
Sponsors and Collaborators
Sprout Pharmaceuticals, Inc
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Sprout Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00996164     History of Changes
Other Study ID Numbers: 511.147
Study First Received: October 15, 2009
Results First Received: March 11, 2014
Last Updated: April 16, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Flibanserin
Serotonin 5-HT1 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin 5-HT2 Receptor Antagonists

ClinicalTrials.gov processed this record on September 18, 2014