Brief Summary

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,723

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Feb 2007

Geographic Reach

2 countries

196 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.5 years study duration

Study Start

First participant enrolled

February 1, 2007

Completed

27 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

March 1, 2007

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed

4.9 years until next milestone

Results Posted

Study results publicly available

June 13, 2014

Completed

Last Updated

June 13, 2014

Status Verified

May 1, 2014

Enrollment Period

2.5 years

First QC Date

February 28, 2007

Results QC Date

May 14, 2014

Last Update Submit

May 14, 2014

Conditions

Sexual Dysfunctions, Psychological

Outcome Measures

Primary Outcomes (1)

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

Study Arms (1)

flibanserin

EXPERIMENTAL

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

Drug: Flibanserin

Interventions

FlibanserinDRUG

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

flibanserin

Eligibility Criteria

Age18 Years - 55 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Women with a primary diagnosis of HSDD who have completed a previous study of Flibanserin.
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.
Patients must be reliable, compliant, and agree to cooperate with all study evaluations.
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.

You may not qualify if:

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.
Participation in another clinical trial within 1 month prior to the start of the study, except for Flibanserin.
Patients with pelvic inflammatory disease, urinary tract infection, vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy.
Patients who are pregnant or have been pregnant within 1 month prior to study start.
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.
Clinically significant ECG or lab abnormalities at study start.
Patients taking prohibited medications that were excluded in their previous trial which contribute to sexual dysfunction or safety-related interactions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Sprout Pharmaceuticals, Inclead

Study Sites (196)

511.84.01079 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

511.84.01193 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

511.84.01188 Boehringer Ingelheim Investigational Site

Huntsville, Alabama, United States

Location

511.84.01110 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Location

511.84.01142 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Location

511.84.01157 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Location

511.84.01162 Boehringer Ingelheim Investigational Site

Little Rock, Alaska, United States

Location

511.84.01070 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Location

511.84.01191 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Location

511.84.01115 Boehringer Ingelheim Investigational Site

Tucson, Arizona, United States

Location

511.84.01013 Boehringer Ingelheim Investigational Site

Jonesboro, Arkansas, United States

Location

511.84.01087 Boehringer Ingelheim Investigational Site

Berkeley, California, United States

Location

511.84.01077 Boehringer Ingelheim Investigational Site

Encinitas, California, United States

Location

511.84.01074 Boehringer Ingelheim Investigational Site

Fair Oaks, California, United States

Location

511.84.01104 Boehringer Ingelheim Investigational Site

Irvine, California, United States

Location

511.84.01037 Boehringer Ingelheim Investigational Site

La Jolla, California, United States

Location

511.84.01056 Boehringer Ingelheim Investigational Site

Sacramento, California, United States

Location

511.84.01195 Boehringer Ingelheim Investigational Site

Sacramento, California, United States

Location

511.84.01043 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

511.84.01047 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

511.84.01096 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

511.84.01040 Boehringer Ingelheim Investigational Site

Stanford, California, United States

Location

511.84.01048 Boehringer Ingelheim Investigational Site

Tarzana, California, United States

Location

511.84.01017 Boehringer Ingelheim Investigational Site

Torrance, California, United States

Location

511.84.01173 Boehringer Ingelheim Investigational Site

Vista, California, United States

Location

511.84.01029 Boehringer Ingelheim Investigational Site

Walnut Creek, California, United States

Location

511.84.01137 Boehringer Ingelheim Investigational Site

Westlake Village, California, United States

Location

511.84.01090 Boehringer Ingelheim Investigational Site

Aurora, Colorado, United States

Location

511.84.01164 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Location

511.84.01184 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Location

511.84.01004 Boehringer Ingelheim Investigational Site

Englewood, Colorado, United States

Location

511.84.01006 Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Location

511.84.01138 Boehringer Ingelheim Investigational Site

Farmington, Connecticut, United States

Location

511.84.01044 Boehringer Ingelheim Investigational Site

Groton, Connecticut, United States

Location

511.84.01016 Boehringer Ingelheim Investigational Site

Hartford, Connecticut, United States

Location

511.84.01108 Boehringer Ingelheim Investigational Site

New Britain, Connecticut, United States

Location

511.84.01168 Boehringer Ingelheim Investigational Site

New London, Connecticut, United States

Location

511.84.01166 Boehringer Ingelheim Investigational Site

Newark, Delaware, United States

Location

511.84.01160 Boehringer Ingelheim Investigational Site

Washington D.C., District of Columbia, United States

Location

511.84.01065 Boehringer Ingelheim Investigational Site

Aventura, Florida, United States

Location

511.84.01005 Boehringer Ingelheim Investigational Site

Boynton Beach, Florida, United States

Location

511.84.01146 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Location

511.84.01144 Boehringer Ingelheim Investigational Site

Coral Gables, Florida, United States

Location

511.84.01169 Boehringer Ingelheim Investigational Site

Daytona Beach, Florida, United States

Location

511.84.01085 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Location

511.84.01194 Boehringer Ingelheim Investigational Site

Fort Meyers, Florida, United States

Location

511.84.01002 Boehringer Ingelheim Investigational Site

Gainesville, Florida, United States

Location

511.84.01069 Boehringer Ingelheim Investigational Site

Gainsville, Florida, United States

Location

511.84.01007 Boehringer Ingelheim Investigational Site

Hudson, Florida, United States

Location

511.84.01055 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

511.84.01064 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

511.84.01182 Boehringer Ingelheim Investigational Site

New Port Richey, Florida, United States

Location

511.84.01167 Boehringer Ingelheim Investigational Site

Ocala, Florida, United States

Location

511.84.01111 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Location

511.84.01118 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Location

511.84.01135 Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

Location

511.84.01032 Boehringer Ingelheim Investigational Site

Plantation, Florida, United States

Location

511.84.01175 Boehringer Ingelheim Investigational Site

Sarasota, Florida, United States

Location

511.84.01053 Boehringer Ingelheim Investigational Site

St. Petersburg, Florida, United States

Location

511.84.01132 Boehringer Ingelheim Investigational Site

St. Petersburg, Florida, United States

Location

511.84.01117 Boehringer Ingelheim Investigational Site

Stuart, Florida, United States

Location

511.84.01159 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

511.84.01170 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

511.84.01183 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

511.84.01003 Boehringer Ingelheim Investigational Site

West Palm Beach, Florida, United States

Location

511.84.01022 Boehringer Ingelheim Investigational Site

West Palm Beach, Florida, United States

Location

511.84.01024 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Location

511.84.01061 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Location

511.84.01205 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Location

511.84.01176 Boehringer Ingelheim Investigational Site

Marietta, Georgia, United States

Location

511.84.01139 Boehringer Ingelheim Investigational Site

Roswell, Georgia, United States

Location

511.84.01023 Boehringer Ingelheim Investigational Site

Sandy Springs, Georgia, United States

Location

511.84.01179 Boehringer Ingelheim Investigational Site

Champaign, Illinois, United States

Location

511.84.01113 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

511.84.01165 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

511.84.01172 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

511.84.01143 Boehringer Ingelheim Investigational Site

Evansville, Indiana, United States

Location

511.84.01092 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

Location

511.84.01202 Boehringer Ingelheim Investigational Site

Wichita, Kansas, United States

Location

511.84.01049 Boehringer Ingelheim Investigational Site

Lexington, Kentucky, United States

Location

511.84.01025 Boehringer Ingelheim Investigational Site

Baton Rouge, Louisiana, United States

Location

511.84.01171 Boehringer Ingelheim Investigational Site

Lafayette, Louisiana, United States

Location

511.84.01192 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

Location

511.84.01130 Boehringer Ingelheim Investigational Site

New Orlean, Louisiana, United States

Location

511.84.01001 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Location

511.84.01120 Boehringer Ingelheim Investigational Site

Brighton, Massachusetts, United States

Location

511.84.01030 Boehringer Ingelheim Investigational Site

Haverhill, Massachusetts, United States

Location

511.84.01127 Boehringer Ingelheim Investigational Site

Ann Arbor, Michigan, United States

Location

511.84.01081 Boehringer Ingelheim Investigational Site

Bingham Farms, Michigan, United States

Location

511.84.01147 Boehringer Ingelheim Investigational Site

Bingham Farms, Michigan, United States

Location

511.84.01041 Boehringer Ingelheim Investigational Site

Detroit, Michigan, United States

Location

511.84.01131 Boehringer Ingelheim Investigational Site

Chaska, Minnesota, United States

Location

511.84.01128 Boehringer Ingelheim Investigational Site

Chesterfield, Missouri, United States

Location

511.84.01051 Boehringer Ingelheim Investigational Site

Kansas City, Missouri, United States

Location

511.84.01034 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

511.84.01042 Boehringer Ingelheim Investigational Site

Billings, Montana, United States

Location

511.84.01156 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

Location

511.84.01148 Boehringer Ingelheim Investigational Site

Las Vegas, Nevada, United States

Location

511.84.01206 Boehringer Ingelheim Investigational Site

Moorestown, New Jersey, United States

Location

511.84.01010 Boehringer Ingelheim Investigational Site

New Brunswick, New Jersey, United States

Location

511.84.01045 Boehringer Ingelheim Investigational Site

Albequerque, New Mexico, United States

Location

511.84.01050 Boehringer Ingelheim Investigational Site

Endwell, New York, United States

Location

511.84.01066 Boehringer Ingelheim Investigational Site

Poughkeepsie, New York, United States

Location

511.84.01187 Boehringer Ingelheim Investigational Site

Purchase, New York, United States

Location

511.84.01038 Boehringer Ingelheim Investigational Site

Rochester, New York, United States

Location

511.84.01059 Boehringer Ingelheim Investigational Site

The Bronx, New York, United States

Location

511.84.01178 Boehringer Ingelheim Investigational Site

Chapel Hill, North Carolina, United States

Location

511.84.01121 Boehringer Ingelheim Investigational Site

New Bern, North Carolina, United States

Location

511.84.01119 Boehringer Ingelheim Investigational Site

Raleigh, North Carolina, United States

Location

511.84.01072 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Location

511.84.01106 Boehringer Ingelheim Investigational Site

Beachwood, Ohio, United States

Location

511.84.01008 Boehringer Ingelheim Investigational Site