A 28-week Safety Study of Flibanserin in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder

April 11, 2014 updated by: Sprout Pharmaceuticals, Inc

Open-label Extension Trial for Pre- and Postmenopausal Women With HSDD

To generate additional long-term safety and efficacy data on flibanserin in premenopausal women and establish long-term safety and tolerability of flibanserin in naturally postmenopausal women with Hypoactive Sexual Desire Disorder who have completed a prior clinical trial of flibanserin (Trial 511.130, 511.147, or 511.156).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

596

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

  • Canada
      • Quebec, Canada
        • 511.133.02002 Boehringer Ingelheim Investigational Site
    • Alberta
      • Calgary, Alberta, Canada
        • 511.133.02004 Boehringer Ingelheim Investigational Site
    • British Columbia
      • Victoria, British Columbia, Canada
        • 511.133.02014 Boehringer Ingelheim Investigational Site
    • Ontario
      • Burlington, Ontario, Canada
        • 511.133.02006 Boehringer Ingelheim Investigational Site
      • Ottawa, Ontario, Canada
        • 511.133.02005 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada
        • 511.133.02016 Boehringer Ingelheim Investigational Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • 511.133.02003 Boehringer Ingelheim Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • 511.133.01074 Boehringer Ingelheim Investigational Site
      • Birmingham, Alabama, United States
        • 511.133.01141 Boehringer Ingelheim Investigational Site
      • Huntsville, Alabama, United States
        • 511.133.01046 Boehringer Ingelheim Investigational Site
      • Mobile, Alabama, United States
        • 511.133.01042 Boehringer Ingelheim Investigational Site
    • Arizona
      • Phoenix, Arizona, United States
        • 511.133.01025 Boehringer Ingelheim Investigational Site
      • Phoenix, Arizona, United States
        • 511.133.01073 Boehringer Ingelheim Investigational Site
      • Tuscon, Arizona, United States
        • 511.133.01127 Boehringer Ingelheim Investigational Site
    • California
      • Encinitas, California, United States
        • 511.133.01030 Boehringer Ingelheim Investigational Site
      • Fair Oaks, California, United States
        • 511.133.01028 Boehringer Ingelheim Investigational Site
      • Irvine, California, United States
        • 511.133.01037 Boehringer Ingelheim Investigational Site
      • La Mesa, California, United States
        • 511.133.01136 Boehringer Ingelheim Investigational Site
      • Newport Beach, California, United States
        • 511.133.01128 Boehringer Ingelheim Investigational Site
      • Oceanside, California, United States
        • 511.133.01115 Boehringer Ingelheim Investigational Site
      • Sacremento, California, United States
        • 511.133.01022 Boehringer Ingelheim Investigational Site
      • San Diego, California, United States
        • 511.133.01035 Boehringer Ingelheim Investigational Site
      • San Diego, California, United States
        • 511.133.01052 Boehringer Ingelheim Investigational Site
      • San Diego, California, United States
        • 511.133.01099 Boehringer Ingelheim Investigational Site
      • Tarzana, California, United States
        • 511.133.01016 Boehringer Ingelheim Investigational Site
      • Vista, California, United States
        • 511.133.01021 Boehringer Ingelheim Investigational Site
      • Westlake Village, California, United States
        • 511.133.01051 Boehringer Ingelheim Investigational Site
    • Colorado
      • Denver, Colorado, United States
        • 511.133.01071 Boehringer Ingelheim Investigational Site
    • Connecticut
      • Farmington, Connecticut, United States
        • 511.133.01053 Boehringer Ingelheim Investigational Site
      • Groton, Connecticut, United States
        • 511.133.01015 Boehringer Ingelheim Investigational Site
      • New London, Connecticut, United States
        • 511.133.01139 Boehringer Ingelheim Investigational Site
    • Delaware
      • Newark, Delaware, United States
        • 511.133.01064 Boehringer Ingelheim Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States
        • 511.133.01062 Boehringer Ingelheim Investigational Site
    • Florida
      • Boynton Beach, Florida, United States
        • 511.133.01003 Boehringer Ingelheim Investigational Site
      • Clearwater, Florida, United States
        • 511.133.01056 Boehringer Ingelheim Investigational Site
      • Coral Gables, Florida, United States
        • 511.133.01132 Boehringer Ingelheim Investigational Site
      • Daytona Beach, Florida, United States
        • 511.133.01065 Boehringer Ingelheim Investigational Site
      • Miami, Florida, United States
        • 511.133.01020 Boehringer Ingelheim Investigational Site
      • Miami, Florida, United States
        • 511.133.01024 Boehringer Ingelheim Investigational Site
      • Orlando, Florida, United States
        • 511.133.01043 Boehringer Ingelheim Investigational Site
      • Palm Harbor, Florida, United States
        • 511.133.01070 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Florida, United States
        • 511.133.01019 Boehringer Ingelheim Investigational Site
      • Tampa, Florida, United States
        • 511.133.01061 Boehringer Ingelheim Investigational Site
      • Tampa, Florida, United States
        • 511.133.01066 Boehringer Ingelheim Investigational Site
      • West Palm Beach, Florida, United States
        • 511.133.01001 Boehringer Ingelheim Investigational Site
      • West Palm Beach, Florida, United States
        • 511.133.01002 Boehringer Ingelheim Investigational Site
    • Georgia
      • Atlanta, Georgia, United States
        • 511.133.01009 Boehringer Ingelheim Investigational Site
      • Atlanta, Georgia, United States
        • 511.133.01023 Boehringer Ingelheim Investigational Site
      • Marietta, Georgia, United States
        • 511.133.01082 Boehringer Ingelheim Investigational Site
      • Sandy Springs, Georgia, United States
        • 511.133.01008 Boehringer Ingelheim Investigational Site
    • Illinois
      • Chicago, Illinois, United States
        • 511.133.01044 Boehringer Ingelheim Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States
        • 511.133.01034 Boehringer Ingelheim Investigational Site
    • Kansas
      • Wichita, Kansas, United States
        • 511.133.01100 Boehringer Ingelheim Investigational Site
    • Louisiana
      • Lafayette, Louisiana, United States
        • 511.133.01067 Boehringer Ingelheim Investigational Site
    • Maryland
      • Baltimore, Maryland, United States
        • 511.133.01013 Boehringer Ingelheim Investigational Site
    • Michigan
      • Bingham Farms, Michigan, United States
        • 511.133.01031 Boehringer Ingelheim Investigational Site
    • Missouri
      • St. Louis, Missouri, United States
        • 511.133.01006 Boehringer Ingelheim Investigational Site
    • Montana
      • Billings, Montana, United States
        • 511.133.01014 Boehringer Ingelheim Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States
        • 511.133.01060 Boehringer Ingelheim Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States
        • 511.133.01057 Boehringer Ingelheim Investigational Site
    • New Jersey
      • Moorestown, New Jersey, United States
        • 511.133.01039 Boehringer Ingelheim Investigational Site
    • New York
      • Endwell, New York, United States
        • 511.133.01017 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Cary, North Carolina, United States
        • 511.133.01135 Boehringer Ingelheim Investigational Site
      • New Bern, North Carolina, United States
        • 511.133.01047 Boehringer Ingelheim Investigational Site
      • Winston Salem, North Carolina, United States
        • 511.133.01138 Boehringer Ingelheim Investigational Site
      • Winston-Salem, North Carolina, United States
        • 511.133.01027 Boehringer Ingelheim Investigational Site
    • North Dakota
      • Fargo, North Dakota, United States
        • 511.133.01119 Boehringer Ingelheim Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States
        • 511.133.01033 Boehringer Ingelheim Investigational Site
      • Cleveland, Ohio, United States
        • 511.133.01004 Boehringer Ingelheim Investigational Site
      • Columbus, Ohio, United States
        • 511.133.01050 Boehringer Ingelheim Investigational Site
      • Columbus, Ohio, United States
        • 511.133.01059 Boehringer Ingelheim Investigational Site
      • Dayton, Ohio, United States
        • 511.133.01058 Boehringer Ingelheim Investigational Site
      • Englewood, Ohio, United States
        • 511.133.01105 Boehringer Ingelheim Investigational Site
    • Oklahoma
      • Edmond, Oklahoma, United States
        • 511.133.01072 Boehringer Ingelheim Investigational Site
    • Oregon
      • Eugene, Oregon, United States
        • 511.133.01007 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • 511.133.01055 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Mt Pleasant, South Carolina, United States
        • 511.133.01068 Boehringer Ingelheim Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States
        • 511.133.01084 Boehringer Ingelheim Investigational Site
      • Knoxville, Tennessee, United States
        • 511.133.01063 Boehringer Ingelheim Investigational Site
      • Nashville, Tennessee, United States
        • 511.133.01010 Boehringer Ingelheim Investigational Site
      • Nashville, Tennessee, United States
        • 511.133.01036 Boehringer Ingelheim Investigational Site
    • Texas
      • Corpus Christi, Texas, United States
        • 511.133.01018 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 511.133.01032 Boehringer Ingelheim Investigational Site
      • Katy, Texas, United States
        • 511.133.01011 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 511.133.01012 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 511.133.01026 Boehringer Ingelheim Investigational Site
    • Utah
      • Salt Lake City, Utah, United States
        • 511.133.01005 Boehringer Ingelheim Investigational Site
      • Sandy, Utah, United States
        • 511.133.01069 Boehringer Ingelheim Investigational Site
    • Virginia
      • Norfolk, Virginia, United States
        • 511.133.01040 Boehringer Ingelheim Investigational Site
      • Richmond, Virginia, United States
        • 511.133.01029 Boehringer Ingelheim Investigational Site
      • Richmond, Virginia, United States
        • 511.133.01075 Boehringer Ingelheim Investigational Site
      • Virgnia Beach, Virginia, United States
        • 511.133.01049 Boehringer Ingelheim Investigational Site
    • Washington
      • Renton, Washington, United States
        • 511.133.01054 Boehringer Ingelheim Investigational Site
      • Spokane, Washington, United States
        • 511.133.01045 Boehringer Ingelheim Investigational Site
      • Tacoma, Washington, United States
        • 511.133.01038 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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion criteria:

  1. Women with primary diagnosis of Hypoactive Sexual Desire Disorder (HSDD) who completed a prior trial of flibanserin. Such completion requires compliance with trial medication and the trial visit schedule including any post-treatment visits required in that clinical trial. Early discontinuation for any reason disqualifies the patient from entry into this trial. Patients must enroll in this study within 7 days after completing the final visit of the parent trial.
  2. The premenopausal patient must use a medically acceptable method of contraception for at least two months before baseline and continue to use medically acceptable method of contraception during the trial.
  3. Postmenopausal patients must be a naturally postmenopausal woman of any age with at least one ovary. Natural menopause is defined as greater than 12 months of spontaneous amenorrhea.
  4. In the investigator's opinion, patients must be willing to adhere to trial requirements as well as to be able to perform them.
  5. Patients must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements. Patients must have sufficient understanding to communicate effectively with the investigator, and be willing to discuss sexual functioning with study staff.

Exclusion criteria:

  1. Patients with history of Major Depressive Disorder (MDD) within six months prior to the Screen Visit, or a score of greater than or equal to 14 on the Beck Depression Inventory II (BDI-II), or a history of suicidal behavior or suicidal ideation according to the Columbia-Suicide Severity Rating Scale (C-SSRS®). If a psychiatrist or psychologist, using clinical judgment, believes a patient who scored between 14 and 19 on the BDI®-II is not depressed, the patient may be entered into the trial. NOTE: If a patient reports positive response to BDI®-II Question 9 and/or a Yes response to either C-SSRS® Suicide Ideation section Question 1 and/or 2 and/or any question in the Suicide Behavior section, please refer to Section 5.2.5 for immediate actions required.
  2. At the Screen Visit, serum alanine aminotransferase, serum aspartate aminotransferase, alkaline phosphatase, or total bilirubin greater than or equal to three times upper limit of normal; blood urea nitrogen greater than or equal to 30 mg/deciliter (dL), plasma creatinine greater than or equal to 2 mg/dL, hemoglobin <9.5 grams/dL, leukopenia (<2.5 x 103/microliter [µL]), neutropenia (<1.5 x 103/µL), lymphopenia (<0.8 x 103/µL), thrombocytopenia (<100 x 103/µL) or thrombocytosis (>500 x 103/µL); or random glucose > upper limit of normal.
  3. Patients with newly developed, self-reported symptoms after the End of Treatment parent trial visit and at this trial Screen Visit of pelvic inflammatory disease, urinary tract or vaginal infection / vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy.
  4. Patients with history of any cancer within the last ten years, other than non-invasive, previously resected basal cell carcinoma of the skin.
  5. Patients whose sexual function was affected by hysterectomy, oophorectomy, or any other pelvic or vaginal surgery.
  6. Patients who are pregnant (by urine pregnancy test at the Screen Visit) or have been pregnant within the month prior to the Screen Visit or who are breast-feeding or have breast-fed within the last six months prior to the Baseline Visit.
  7. Patients receiving medication excluded in their prior safety and efficacy trial of flibanserin causing sexual dysfunction or safety-relevant interactions (i.e., antidepressants, anxiolytics, antipsychotics, anticonvulsants, anticoagulants).
  8. Patients with clinically relevant conditions which might interfere with their ability to participate in the trial.
  9. Participation in a trial of an investigational medication other than flibanserin within one month prior to the Screen Visit.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: flibanserin 100mg
flibanserin 100mg po qd
Drug: flibanserin
all patients will receive open-label flibanserin 100mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Frequency of Adverse Events
Time Frame: A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD
A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD

Collaborators and Investigators

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

Sponsor

Sprout Pharmaceuticals, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2010

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

April 13, 2010

First Submitted That Met QC Criteria

April 13, 2010

First Posted (ESTIMATE)

April 14, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 12, 2014

Last Update Submitted That Met QC Criteria

April 11, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 511.133

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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