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

April 16, 2014 updated by: Sprout Pharmaceuticals, Inc

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1090

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • 511.147.01074 Boehringer Ingelheim Investigational Site
      • Huntsville, Alabama, United States
        • 511.147.01046 Boehringer Ingelheim Investigational Site
      • Mobile, Alabama, United States
        • 511.147.01042 Boehringer Ingelheim Investigational Site
    • Arizona
      • Phoenix, Arizona, United States
        • 511.147.01025 Boehringer Ingelheim Investigational Site
      • Phoenix, Arizona, United States
        • 511.147.01073 Boehringer Ingelheim Investigational Site
    • California
      • Encinitas, California, United States
        • 511.147.01030 Boehringer Ingelheim Investigational Site
      • Fair Oaks, California, United States
        • 511.147.01028 Boehringer Ingelheim Investigational Site
      • Irvine, California, United States
        • 511.147.01037 Boehringer Ingelheim Investigational Site
      • Sacramento, California, United States
        • 511.147.01022 Boehringer Ingelheim Investigational Site
      • San Diego, California, United States
        • 511.147.01035 Boehringer Ingelheim Investigational Site
      • San Diego, California, United States
        • 511.147.01052 Boehringer Ingelheim Investigational Site
      • Torrance, California, United States
        • 511.147.01016 Boehringer Ingelheim Investigational Site
      • Vista, California, United States
        • 511.147.01021 Boehringer Ingelheim Investigational Site
      • Westlake Village, California, United States
        • 511.147.01051 Boehringer Ingelheim Investigational Site
    • Colorado
      • Denver, Colorado, United States
        • 511.147.01071 Boehringer Ingelheim Investigational Site
    • Connecticut
      • Farmington, Connecticut, United States
        • 511.147.01053 Boehringer Ingelheim Investigational Site
      • Groton, Connecticut, United States
        • 511.147.01015 Boehringer Ingelheim Investigational Site
      • New Britain, Connecticut, United States
        • 511.147.01041 Boehringer Ingelheim Investigational Site
    • Delaware
      • Newark, Delaware, United States
        • 511.147.01064 Boehringer Ingelheim Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States
        • 511.147.01062 Boehringer Ingelheim Investigational Site
    • Florida
      • Boynton Beach, Florida, United States
        • 511.147.01003 Boehringer Ingelheim Investigational Site
      • Clearwater, Florida, United States
        • 511.147.01056 Boehringer Ingelheim Investigational Site
      • Daytona Beach, Florida, United States
        • 511.147.01065 Boehringer Ingelheim Investigational Site
      • Miami, Florida, United States
        • 511.147.01020 Boehringer Ingelheim Investigational Site
      • Miami, Florida, United States
        • 511.147.01024 Boehringer Ingelheim Investigational Site
      • New Port Richey, Florida, United States
        • 511.147.01070 Boehringer Ingelheim Investigational Site
      • Orlando, Florida, United States
        • 511.147.01043 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Florida, United States
        • 511.147.01019 Boehringer Ingelheim Investigational Site
      • Tampa, Florida, United States
        • 511.147.01061 Boehringer Ingelheim Investigational Site
      • Tampa, Florida, United States
        • 511.147.01066 Boehringer Ingelheim Investigational Site
      • West Palm Beach, Florida, United States
        • 511.147.01001 Boehringer Ingelheim Investigational Site
      • West Palm Beach, Florida, United States
        • 511.147.01002 Boehringer Ingelheim Investigational Site
    • Georgia
      • Atlanta, Georgia, United States
        • 511.147.01009 Boehringer Ingelheim Investigational Site
      • Atlanta, Georgia, United States
        • 511.147.01023 Boehringer Ingelheim Investigational Site
      • Sandy Springs, Georgia, United States
        • 511.147.01008 Boehringer Ingelheim Investigational Site
    • Illinois
      • Chicago, Illinois, United States
        • 511.147.01044 Boehringer Ingelheim Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States
        • 511.147.01034 Boehringer Ingelheim Investigational Site
    • Louisiana
      • Lafayette, Louisiana, United States
        • 511.147.01067 Boehringer Ingelheim Investigational Site
    • Maryland
      • Baltimore, Maryland, United States
        • 511.147.01013 Boehringer Ingelheim Investigational Site
    • Michigan
      • Bingham Farms, Michigan, United States
        • 511.147.01031 Boehringer Ingelheim Investigational Site
    • Missouri
      • St. Louis, Missouri, United States
        • 511.147.01006 Boehringer Ingelheim Investigational Site
    • Montana
      • Billings, Montana, United States
        • 511.147.01014 Boehringer Ingelheim Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States
        • 511.147.01060 Boehringer Ingelheim Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States
        • 511.147.01057 Boehringer Ingelheim Investigational Site
    • New Jersey
      • Moorestown, New Jersey, United States
        • 511.147.01039 Boehringer Ingelheim Investigational Site
    • New York
      • Endwell, New York, United States
        • 511.147.01017 Boehringer Ingelheim Investigational Site
    • North Carolina
      • New Bern, North Carolina, United States
        • 511.147.01047 Boehringer Ingelheim Investigational Site
      • Winston-Salem, North Carolina, United States
        • 511.147.01027 Boehringer Ingelheim Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States
        • 511.147.01033 Boehringer Ingelheim Investigational Site
      • Cleveland, Ohio, United States
        • 511.147.01004 Boehringer Ingelheim Investigational Site
      • Columbus, Ohio, United States
        • 511.147.01050 Boehringer Ingelheim Investigational Site
      • Columbus, Ohio, United States
        • 511.147.01059 Boehringer Ingelheim Investigational Site
      • Dayton, Ohio, United States
        • 511.147.01058 Boehringer Ingelheim Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • 511.147.01072 Boehringer Ingelheim Investigational Site
    • Oregon
      • Eugene, Oregon, United States
        • 511.147.01007 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • 511.147.01055 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States
        • 511.147.01048 Boehringer Ingelheim Investigational Site
      • Mt. Pleasant, South Carolina, United States
        • 511.147.01068 Boehringer Ingelheim Investigational Site
    • Tennessee
      • Knoxville, Tennessee, United States
        • 511.147.01063 Boehringer Ingelheim Investigational Site
      • Nashville, Tennessee, United States
        • 511.147.01010 Boehringer Ingelheim Investigational Site
      • Nashville, Tennessee, United States
        • 511.147.01036 Boehringer Ingelheim Investigational Site
    • Texas
      • Corpus Christi, Texas, United States
        • 511.147.01018 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 511.147.01032 Boehringer Ingelheim Investigational Site
      • Katy, Texas, United States
        • 511.147.01011 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 511.147.01012 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 511.147.01026 Boehringer Ingelheim Investigational Site
    • Utah
      • Salt Lake City, Utah, United States
        • 511.147.01005 Boehringer Ingelheim Investigational Site
      • Sandy, Utah, United States
        • 511.147.01069 Boehringer Ingelheim Investigational Site
    • Virginia
      • Norfolk, Virginia, United States
        • 511.147.01040 Boehringer Ingelheim Investigational Site
      • Norfolk, Virginia, United States
        • 511.147.01049 Boehringer Ingelheim Investigational Site
      • Richmond, Virginia, United States
        • 511.147.01029 Boehringer Ingelheim Investigational Site
      • Richmond, Virginia, United States
        • 511.147.01075 Boehringer Ingelheim Investigational Site
    • Washington
      • Renton, Washington, United States
        • 511.147.01054 Boehringer Ingelheim Investigational Site
      • Spokane, Washington, United States
        • 511.147.01045 Boehringer Ingelheim Investigational Site
      • Tacoma, Washington, United States
        • 511.147.01038 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 weeks
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.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sprout Pharmaceuticals, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

February 1, 2011

Study Registration Dates

First Submitted

October 15, 2009

First Submitted That Met QC Criteria

October 15, 2009

First Posted (ESTIMATE)

October 16, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

May 19, 2014

Last Update Submitted That Met QC Criteria

April 16, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 511.147

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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