A One-year Safety Study of Flibanserin to Treat Pre-Menopausal Women With Hypoactive Sexual Desire Disorder (HSDD).

May 14, 2014 updated by: Sprout Pharmaceuticals, Inc

Worldwide One-year Open-label Safety Study of Flibanserin in Women With HSDD

To determine if long-term treatment with Flibanserin is safe and to monitor the effectiveness of Flibanserin in Women with HSDD that have already completed a previous study (511.70/71/.74/.75/.105) with Flibanserin.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1723

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
        • 511.84.02020 Boehringer Ingelheim Investigational Site
    • Alberta
      • Calgary, Alberta, Canada
        • 511.84.02007 Boehringer Ingelheim Investigational Site
    • British Columbia
      • Coquitlam, British Columbia, Canada
        • 511.84.02014 Boehringer Ingelheim Investigational Site
      • North Vancouver, British Columbia, Canada
        • 511.84.02002 Boehringer Ingelheim Investigational Site
      • Surrey, British Columbia, Canada
        • 511.84.02021 Boehringer Ingelheim Investigational Site
      • Vancouver, British Columbia, Canada
        • 511.84.02013 Boehringer Ingelheim Investigational Site
      • Victoria, British Columbia, Canada
        • 511.84.02015 Boehringer Ingelheim Investigational Site
      • Victoria, British Columbia, Canada
        • 511.84.02023 Boehringer Ingelheim Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • 511.84.02017 Boehringer Ingelheim Investigational Site
    • New Brunswick
      • Woodstock, New Brunswick, Canada
        • 511.84.02010 Boehringer Ingelheim Investigational Site
    • Newfoundland and Labrador
      • Mount Pearl, Newfoundland and Labrador, Canada
        • 511.84.02012 Boehringer Ingelheim Investigational Site
      • St. John's, Newfoundland and Labrador, Canada
        • 511.84.02006 Boehringer Ingelheim Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • 511.84.02003 Boehringer Ingelheim Investigational Site
    • Ontario
      • Barrie, Ontario, Canada
        • 511.84.02018 Boehringer Ingelheim Investigational Site
      • Burlington, Ontario, Canada
        • 511.84.02009 Boehringer Ingelheim Investigational Site
      • London, Ontario, Canada
        • 511.84.02022 Boehringer Ingelheim Investigational Site
      • London, Ontario, Canada
        • 511.84.02024 Boehringer Ingelheim Investigational Site
      • Ottawa, Ontario, Canada
        • 511.84.02001 Boehringer Ingelheim Investigational Site
      • Ottawa, Ontario, Canada
        • 511.84.02008 Boehringer Ingelheim Investigational Site
    • Quebec
      • Montréal, Quebec, Canada
        • 511.84.02011 Boehringer Ingelheim Investigational Site
      • Québec, Quebec, Canada
        • 511.84.02019 Boehringer Ingelheim Investigational Site
      • Sherbrooke, Quebec, Canada
        • 511.84.02005 Boehringer Ingelheim Investigational Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • 511.84.02004 Boehringer Ingelheim Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • 511.84.01079 Boehringer Ingelheim Investigational Site
      • Birmingham, Alabama, United States
        • 511.84.01193 Boehringer Ingelheim Investigational Site
      • Huntsville, Alabama, United States
        • 511.84.01188 Boehringer Ingelheim Investigational Site
      • Mobile, Alabama, United States
        • 511.84.01110 Boehringer Ingelheim Investigational Site
      • Mobile, Alabama, United States
        • 511.84.01142 Boehringer Ingelheim Investigational Site
      • Mobile, Alabama, United States
        • 511.84.01157 Boehringer Ingelheim Investigational Site
    • Alaska
      • Little Rock, Alaska, United States
        • 511.84.01162 Boehringer Ingelheim Investigational Site
    • Arizona
      • Phoenix, Arizona, United States
        • 511.84.01070 Boehringer Ingelheim Investigational Site
      • Phoenix, Arizona, United States
        • 511.84.01191 Boehringer Ingelheim Investigational Site
      • Tucson, Arizona, United States
        • 511.84.01115 Boehringer Ingelheim Investigational Site
    • Arkansas
      • Jonesboro, Arkansas, United States
        • 511.84.01013 Boehringer Ingelheim Investigational Site
    • California
      • Berkeley, California, United States
        • 511.84.01087 Boehringer Ingelheim Investigational Site
      • Encinitas, California, United States
        • 511.84.01077 Boehringer Ingelheim Investigational Site
      • Fair Oaks, California, United States
        • 511.84.01074 Boehringer Ingelheim Investigational Site
      • Irvine, California, United States
        • 511.84.01104 Boehringer Ingelheim Investigational Site
      • La Jolla, California, United States
        • 511.84.01037 Boehringer Ingelheim Investigational Site
      • Sacramento, California, United States
        • 511.84.01056 Boehringer Ingelheim Investigational Site
      • Sacramento, California, United States
        • 511.84.01195 Boehringer Ingelheim Investigational Site
      • San Diego, California, United States
        • 511.84.01043 Boehringer Ingelheim Investigational Site
      • San Diego, California, United States
        • 511.84.01047 Boehringer Ingelheim Investigational Site
      • San Diego, California, United States
        • 511.84.01096 Boehringer Ingelheim Investigational Site
      • Stanford, California, United States
        • 511.84.01040 Boehringer Ingelheim Investigational Site
      • Tarzana, California, United States
        • 511.84.01048 Boehringer Ingelheim Investigational Site
      • Torrance, California, United States
        • 511.84.01017 Boehringer Ingelheim Investigational Site
      • Vista, California, United States
        • 511.84.01173 Boehringer Ingelheim Investigational Site
      • Walnut Creek, California, United States
        • 511.84.01029 Boehringer Ingelheim Investigational Site
      • Westlake Village, California, United States
        • 511.84.01137 Boehringer Ingelheim Investigational Site
    • Colorado
      • Aurora, Colorado, United States
        • 511.84.01090 Boehringer Ingelheim Investigational Site
      • Denver, Colorado, United States
        • 511.84.01164 Boehringer Ingelheim Investigational Site
      • Denver, Colorado, United States
        • 511.84.01184 Boehringer Ingelheim Investigational Site
      • Englewood, Colorado, United States
        • 511.84.01004 Boehringer Ingelheim Investigational Site
      • Wheatridge, Colorado, United States
        • 511.84.01006 Boehringer Ingelheim Investigational Site
    • Connecticut
      • Farmington, Connecticut, United States
        • 511.84.01138 Boehringer Ingelheim Investigational Site
      • Groton, Connecticut, United States
        • 511.84.01044 Boehringer Ingelheim Investigational Site
      • Hartford, Connecticut, United States
        • 511.84.01016 Boehringer Ingelheim Investigational Site
      • New Britain, Connecticut, United States
        • 511.84.01108 Boehringer Ingelheim Investigational Site
      • New London, Connecticut, United States
        • 511.84.01168 Boehringer Ingelheim Investigational Site
    • Delaware
      • Newark, Delaware, United States
        • 511.84.01166 Boehringer Ingelheim Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States
        • 511.84.01160 Boehringer Ingelheim Investigational Site
    • Florida
      • Aventura, Florida, United States
        • 511.84.01065 Boehringer Ingelheim Investigational Site
      • Boynton Beach, Florida, United States
        • 511.84.01005 Boehringer Ingelheim Investigational Site
      • Clearwater, Florida, United States
        • 511.84.01146 Boehringer Ingelheim Investigational Site
      • Coral Gables, Florida, United States
        • 511.84.01144 Boehringer Ingelheim Investigational Site
      • Daytona Beach, Florida, United States
        • 511.84.01169 Boehringer Ingelheim Investigational Site
      • Fort Lauderdale, Florida, United States
        • 511.84.01085 Boehringer Ingelheim Investigational Site
      • Fort Meyers, Florida, United States
        • 511.84.01194 Boehringer Ingelheim Investigational Site
      • Gainesville, Florida, United States
        • 511.84.01002 Boehringer Ingelheim Investigational Site
      • Gainsville, Florida, United States
        • 511.84.01069 Boehringer Ingelheim Investigational Site
      • Hudson, Florida, United States
        • 511.84.01007 Boehringer Ingelheim Investigational Site
      • Miami, Florida, United States
        • 511.84.01055 Boehringer Ingelheim Investigational Site
      • Miami, Florida, United States
        • 511.84.01064 Boehringer Ingelheim Investigational Site
      • New Port Richey, Florida, United States
        • 511.84.01182 Boehringer Ingelheim Investigational Site
      • Ocala, Florida, United States
        • 511.84.01167 Boehringer Ingelheim Investigational Site
      • Orlando, Florida, United States
        • 511.84.01111 Boehringer Ingelheim Investigational Site
      • Orlando, Florida, United States
        • 511.84.01118 Boehringer Ingelheim Investigational Site
      • Pembroke Pines, Florida, United States
        • 511.84.01135 Boehringer Ingelheim Investigational Site
      • Plantation, Florida, United States
        • 511.84.01032 Boehringer Ingelheim Investigational Site
      • Sarasota, Florida, United States
        • 511.84.01175 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Florida, United States
        • 511.84.01053 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Florida, United States
        • 511.84.01132 Boehringer Ingelheim Investigational Site
      • Stuart, Florida, United States
        • 511.84.01117 Boehringer Ingelheim Investigational Site
      • Tampa, Florida, United States
        • 511.84.01159 Boehringer Ingelheim Investigational Site
      • Tampa, Florida, United States
        • 511.84.01170 Boehringer Ingelheim Investigational Site
      • Tampa, Florida, United States
        • 511.84.01183 Boehringer Ingelheim Investigational Site
      • West Palm Beach, Florida, United States
        • 511.84.01003 Boehringer Ingelheim Investigational Site
      • West Palm Beach, Florida, United States
        • 511.84.01022 Boehringer Ingelheim Investigational Site
    • Georgia
      • Atlanta, Georgia, United States
        • 511.84.01024 Boehringer Ingelheim Investigational Site
      • Atlanta, Georgia, United States
        • 511.84.01061 Boehringer Ingelheim Investigational Site
      • Atlanta, Georgia, United States
        • 511.84.01205 Boehringer Ingelheim Investigational Site
      • Marietta, Georgia, United States
        • 511.84.01176 Boehringer Ingelheim Investigational Site
      • Roswell, Georgia, United States
        • 511.84.01139 Boehringer Ingelheim Investigational Site
      • Sandy Springs, Georgia, United States
        • 511.84.01023 Boehringer Ingelheim Investigational Site
    • Illinois
      • Champaign, Illinois, United States
        • 511.84.01179 Boehringer Ingelheim Investigational Site
      • Chicago, Illinois, United States
        • 511.84.01113 Boehringer Ingelheim Investigational Site
      • Chicago, Illinois, United States
        • 511.84.01165 Boehringer Ingelheim Investigational Site
      • Chicago, Illinois, United States
        • 511.84.01172 Boehringer Ingelheim Investigational Site
    • Indiana
      • Evansville, Indiana, United States
        • 511.84.01143 Boehringer Ingelheim Investigational Site
      • Indianapolis, Indiana, United States
        • 511.84.01092 Boehringer Ingelheim Investigational Site
    • Kansas
      • Wichita, Kansas, United States
        • 511.84.01202 Boehringer Ingelheim Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States
        • 511.84.01049 Boehringer Ingelheim Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States
        • 511.84.01025 Boehringer Ingelheim Investigational Site
      • Lafayette, Louisiana, United States
        • 511.84.01171 Boehringer Ingelheim Investigational Site
      • New Orlean, Louisiana, United States
        • 511.84.01130 Boehringer Ingelheim Investigational Site
      • New Orleans, Louisiana, United States
        • 511.84.01192 Boehringer Ingelheim Investigational Site
    • Maryland
      • Baltimore, Maryland, United States
        • 511.84.01001 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Brighton, Massachusetts, United States
        • 511.84.01120 Boehringer Ingelheim Investigational Site
      • Haverhill, Massachusetts, United States
        • 511.84.01030 Boehringer Ingelheim Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States
        • 511.84.01127 Boehringer Ingelheim Investigational Site
      • Bingham Farms, Michigan, United States
        • 511.84.01081 Boehringer Ingelheim Investigational Site
      • Bingham Farms, Michigan, United States
        • 511.84.01147 Boehringer Ingelheim Investigational Site
      • Detroit, Michigan, United States
        • 511.84.01041 Boehringer Ingelheim Investigational Site
    • Minnesota
      • Chaska, Minnesota, United States
        • 511.84.01131 Boehringer Ingelheim Investigational Site
    • Missouri
      • Chesterfield, Missouri, United States
        • 511.84.01128 Boehringer Ingelheim Investigational Site
      • Kansas City, Missouri, United States
        • 511.84.01051 Boehringer Ingelheim Investigational Site
      • St. Louis, Missouri, United States
        • 511.84.01034 Boehringer Ingelheim Investigational Site
    • Montana
      • Billings, Montana, United States
        • 511.84.01042 Boehringer Ingelheim Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States
        • 511.84.01156 Boehringer Ingelheim Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States
        • 511.84.01148 Boehringer Ingelheim Investigational Site
    • New Jersey
      • Moorestown, New Jersey, United States
        • 511.84.01206 Boehringer Ingelheim Investigational Site
      • New Brunswick, New Jersey, United States
        • 511.84.01010 Boehringer Ingelheim Investigational Site
    • New Mexico
      • Albequerque, New Mexico, United States
        • 511.84.01045 Boehringer Ingelheim Investigational Site
    • New York
      • Bronx, New York, United States
        • 511.84.01059 Boehringer Ingelheim Investigational Site
      • Endwell, New York, United States
        • 511.84.01050 Boehringer Ingelheim Investigational Site
      • Poughkeepsie, New York, United States
        • 511.84.01066 Boehringer Ingelheim Investigational Site
      • Purchase, New York, United States
        • 511.84.01187 Boehringer Ingelheim Investigational Site
      • Rochester, New York, United States
        • 511.84.01038 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • 511.84.01178 Boehringer Ingelheim Investigational Site
      • New Bern, North Carolina, United States
        • 511.84.01121 Boehringer Ingelheim Investigational Site
      • Raleigh, North Carolina, United States
        • 511.84.01119 Boehringer Ingelheim Investigational Site
      • Winston-Salem, North Carolina, United States
        • 511.84.01072 Boehringer Ingelheim Investigational Site
    • Ohio
      • Beachwood, Ohio, United States
        • 511.84.01106 Boehringer Ingelheim Investigational Site
      • Cincinnati, Ohio, United States
        • 511.84.01008 Boehringer Ingelheim Investigational Site
      • Cincinnati, Ohio, United States
        • 511.84.01062 Boehringer Ingelheim Investigational Site
      • Cincinnati, Ohio, United States
        • 511.84.01089 Boehringer Ingelheim Investigational Site
      • Cincinnati, Ohio, United States
        • 511.84.01197 Boehringer Ingelheim Investigational Site
      • Cincinnati, Ohio, United States
        • 511.84.01201 Boehringer Ingelheim Investigational Site
      • Cleveland, Ohio, United States
        • 511.84.01009 Boehringer Ingelheim Investigational Site
      • Cleveland, Ohio, United States
        • 511.84.01014 Boehringer Ingelheim Investigational Site
      • Cleveland, Ohio, United States
        • 511.84.01152 Boehringer Ingelheim Investigational Site
      • Columbus, Ohio, United States
        • 511.84.01136 Boehringer Ingelheim Investigational Site
      • Columbus, Ohio, United States
        • 511.84.01149 Boehringer Ingelheim Investigational Site
      • Columbus, Ohio, United States
        • 511.84.01151 Boehringer Ingelheim Investigational Site
      • Dayton, Ohio, United States
        • 511.84.01150 Boehringer Ingelheim Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • 511.84.01190 Boehringer Ingelheim Investigational Site
      • Tulsa, Oklahoma, United States
        • 511.84.01112 Planned Parenthood of Arkansas & Estrn Oklahoma, Inc
      • Tulsa, Oklahoma, United States
        • 511.84.01185 Boehringer Ingelheim Investigational Site
    • Oregon
      • Eugene, Oregon, United States
        • 511.84.01019 Boehringer Ingelheim Investigational Site
      • Medfod, Oregon, United States
        • 511.84.01134 Boehringer Ingelheim Investigational Site
      • Portland, Oregon, United States
        • 511.84.01103 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States
        • 511.84.01088 Boehringer Ingelheim Investigational Site
      • Philadelphia, Pennsylvania, United States
        • 511.84.01067 Boehringer Ingelheim Investigational Site
      • Philadelphia, Pennsylvania, United States
        • 511.84.01153 Boehringer Ingelheim Investigational Site
      • Pittsburgh, Pennsylvania, United States
        • 511.84.01145 Boehringer Ingelheim Investigational Site
      • West Reading, Pennsylvania, United States
        • 511.84.01054 Boehringer Ingelheim Investigational Site
      • Wilkes-Barre, Pennsylvania, United States
        • 511.84.01021 Boehringer Ingelheim Investigational Site
    • Rhode Island
      • Warwick, Rhode Island, United States
        • 511.84.01060 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Anderson, South Carolina, United States
        • 511.84.01063 Boehringer Ingelheim Investigational Site
      • Columbia, South Carolina, United States
        • 511.84.01124 Boehringer Ingelheim Investigational Site
      • Greenville, South Carolina, United States
        • 511.84.01123 Boehringer Ingelheim Investigational Site
      • Mt. Pleasant, South Carolina, United States
        • 511.84.01109 Boehringer Ingelheim Investigational Site
    • Tennessee
      • Germantown, Tennessee, United States
        • 511.84.01174 Boehringer Ingelheim Investigational Site
      • Knoxville, Tennessee, United States
        • 511.84.01163 Boehringer Ingelheim Investigational Site
      • Nashville, Tennessee, United States
        • 511.84.01026 Boehringer Ingelheim Investigational Site
      • Nashville, Tennessee, United States
        • 511.84.01100 Boehringer Ingelheim Investigational Site
    • Texas
      • Austin, Texas, United States
        • 511.84.01078 Boehringer Ingelheim Investigational Site
      • Corpus Christi, Texas, United States
        • 511.84.01052 Boehringer Ingelheim Investigational Site
      • Dallas, Texas, United States
        • 511.84.01027 Boehringer Ingelheim Investigational Site
      • Dallas, Texas, United States
        • 511.84.01140 Boehringer Ingelheim Investigational Site
      • Fort Worth, Texas, United States
        • 511.84.01084 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 511.84.01057 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 511.84.01082 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 511.84.01198 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 511.84.01036 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 511.84.01071 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 511.84.01083 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 511.84.01086 Boehringer Ingelheim Investigational Site
      • Waco, Texas, United States
        • 511.84.01098 Boehringer Ingelheim Investigational Site
    • Utah
      • Salt Lake City, Utah, United States
        • 511.84.01015 Boehringer Ingelheim Investigational Site
      • Sandy, Utah, United States
        • 511.84.01180 Boehringer Ingelheim Investigational Site
    • Vermont
      • Burlington, Vermont, United States
        • 511.84.01028 Boehringer Ingelheim Investigational Site
    • Virginia
      • Charlottesville, Virginia, United States
        • 511.84.01031 Boehringer Ingelheim Investigational Site
      • Charlottesville, Virginia, United States
        • 511.84.01035 Boehringer Ingelheim Investigational Site
      • Norfolk, Virginia, United States
        • 511.84.01107 Boehringer Ingelheim Investigational Site
      • Norfolk, Virginia, United States
        • 511.84.01125 Boehringer Ingelheim Investigational Site
      • Richmond, Virginia, United States
        • 511.84.01076 Boehringer Ingelheim Investigational Site
      • Richmond, Virginia, United States
        • 511.84.01097 Boehringer Ingelheim Investigational Site
      • Richmond, Virginia, United States
        • 511.84.01196 Boehringer Ingelheim Investigational Site
    • Washington
      • Bellevue, Washington, United States
        • 511.84.01093 Boehringer Ingelheim Investigational Site
      • Renton, Washington, United States
        • 511.84.01141 Boehringer Ingelheim Investigational Site
      • Seattle, Washington, United States
        • 511.84.01012 Boehringer Ingelheim Investigational Site
      • Spokane, Washington, United States
        • 511.84.01116 Boehringer Ingelheim Investigational Site
      • Tacoma, Washington, United States
        • 511.84.01105 Boehringer Ingelheim Investigational Site
    • Wisconsin
      • Middleton, Wisconsin, United States
        • 511.84.01177 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. Women with a primary diagnosis of HSDD who have completed a previous study of Flibanserin.
  2. Patients must have used a medically acceptable method of contraception for at least 2 months before the start of the study and continue to use that method for the duration of the study.
  3. Patients must be reliable, compliant, and agree to cooperate with all study evaluations.
  4. Patients must be able and willing to give meaningful, written informed consent prior to the start of the study and be willing to discuss their sexual functioning with the study staff.

Exclusion Criteria:

  1. A history of Major Depressive Disorder within 6 months prior to the start of the study, current suicidal thoughts, or any history of a suicide attempt.
  2. Participation in another clinical trial within 1 month prior to the start of the study, except for Flibanserin.
  3. Patients with pelvic inflammatory disease, urinary tract infection, vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy.
  4. Patients who are pregnant or have been pregnant within 1 month prior to study start.
  5. Patients experiencing major life stress (including loss of income, death of a family member, major illness, etc.) or relationship trouble that could interfere with sexual activity, except distress about HSDD.
  6. Clinically significant ECG or lab abnormalities at study start.
  7. Patients taking prohibited medications that were excluded in their previous trial which contribute to sexual dysfunction or safety-related interactions.

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
flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
Drug: Flibanserin
flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Frequency of Adverse Events (Side Effects).
Time Frame: 52 weeks
This is a 52-week, open label trial assessing safety/tolerability of flibanserin in women with Hypoactive Sexual Desire Disorder
52 weeks

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

February 1, 2007

Primary Completion (ACTUAL)

August 1, 2009

Study Completion (ACTUAL)

August 1, 2009

Study Registration Dates

First Submitted

February 28, 2007

First Submitted That Met QC Criteria

February 28, 2007

First Posted (ESTIMATE)

March 1, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

June 13, 2014

Last Update Submitted That Met QC Criteria

May 14, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 511.84

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.

Clinical Trials on Sexual Dysfunctions, Psychological

Clinical Trials on Flibanserin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe