Sexual Dysfunctions, PsychologicalPhase 3NCT00441558

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

A Phase 3 study testing Flibanserin in people with Sexual Dysfunctions, Psychological, run by Sprout Pharmaceuticals, Inc at 196 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 years, women only
Conditions the study is for: Sexual Dysfunctions, Psychological
What is being tested?: Flibanserin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,723 participants
Where: 196 sitesin 2 countries
Study dates: Feb 2007to Aug 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Women only
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

196 sites in 2 countries.

Country

City, postcode or hospital

196 sites in 2 countries

United States173 sites

511.84.01045 Boehringer Ingelheim Investigational Site
Albequerque, New Mexico
511.84.01063 Boehringer Ingelheim Investigational Site
Anderson, South Carolina
511.84.01127 Boehringer Ingelheim Investigational Site
Ann Arbor, Michigan
511.84.01024 Boehringer Ingelheim Investigational Site
Atlanta, Georgia
511.84.01061 Boehringer Ingelheim Investigational Site
Atlanta, Georgia
511.84.01205 Boehringer Ingelheim Investigational Site
Atlanta, Georgia
511.84.01090 Boehringer Ingelheim Investigational Site
Aurora, Colorado
511.84.01078 Boehringer Ingelheim Investigational Site
Austin, Texas
511.84.01065 Boehringer Ingelheim Investigational Site
Aventura, Florida
511.84.01001 Boehringer Ingelheim Investigational Site
Baltimore, Maryland
511.84.01025 Boehringer Ingelheim Investigational Site
Baton Rouge, Louisiana
511.84.01106 Boehringer Ingelheim Investigational Site
Beachwood, Ohio
511.84.01093 Boehringer Ingelheim Investigational Site
Bellevue, Washington
511.84.01087 Boehringer Ingelheim Investigational Site
Berkeley, California
511.84.01042 Boehringer Ingelheim Investigational Site
Billings, Montana
511.84.01081 Boehringer Ingelheim Investigational Site
Bingham Farms, Michigan
511.84.01147 Boehringer Ingelheim Investigational Site
Bingham Farms, Michigan
511.84.01079 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
511.84.01193 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
511.84.01005 Boehringer Ingelheim Investigational Site
Boynton Beach, Florida
511.84.01120 Boehringer Ingelheim Investigational Site
Brighton, Massachusetts
511.84.01028 Boehringer Ingelheim Investigational Site
Burlington, Vermont
511.84.01179 Boehringer Ingelheim Investigational Site
Champaign, Illinois
511.84.01178 Boehringer Ingelheim Investigational Site
Chapel Hill, North Carolina
511.84.01031 Boehringer Ingelheim Investigational Site
Charlottesville, Virginia
511.84.01035 Boehringer Ingelheim Investigational Site
Charlottesville, Virginia
511.84.01131 Boehringer Ingelheim Investigational Site
Chaska, Minnesota
511.84.01128 Boehringer Ingelheim Investigational Site
Chesterfield, Missouri
511.84.01113 Boehringer Ingelheim Investigational Site
Chicago, Illinois
511.84.01165 Boehringer Ingelheim Investigational Site
Chicago, Illinois
511.84.01172 Boehringer Ingelheim Investigational Site
Chicago, Illinois
511.84.01008 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
511.84.01062 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
511.84.01089 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
511.84.01197 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
511.84.01201 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
511.84.01146 Boehringer Ingelheim Investigational Site
Clearwater, Florida
511.84.01009 Boehringer Ingelheim Investigational Site
Cleveland, Ohio
511.84.01014 Boehringer Ingelheim Investigational Site
Cleveland, Ohio
511.84.01152 Boehringer Ingelheim Investigational Site
Cleveland, Ohio
511.84.01124 Boehringer Ingelheim Investigational Site
Columbia, South Carolina
511.84.01136 Boehringer Ingelheim Investigational Site
Columbus, Ohio
511.84.01149 Boehringer Ingelheim Investigational Site
Columbus, Ohio
511.84.01151 Boehringer Ingelheim Investigational Site
Columbus, Ohio
511.84.01144 Boehringer Ingelheim Investigational Site
Coral Gables, Florida
511.84.01052 Boehringer Ingelheim Investigational Site
Corpus Christi, Texas
511.84.01027 Boehringer Ingelheim Investigational Site
Dallas, Texas
511.84.01140 Boehringer Ingelheim Investigational Site
Dallas, Texas
511.84.01150 Boehringer Ingelheim Investigational Site
Dayton, Ohio
511.84.01169 Boehringer Ingelheim Investigational Site
Daytona Beach, Florida
511.84.01164 Boehringer Ingelheim Investigational Site
Denver, Colorado
511.84.01184 Boehringer Ingelheim Investigational Site
Denver, Colorado
511.84.01041 Boehringer Ingelheim Investigational Site
Detroit, Michigan
511.84.01077 Boehringer Ingelheim Investigational Site
Encinitas, California
511.84.01050 Boehringer Ingelheim Investigational Site
Endwell, New York
511.84.01004 Boehringer Ingelheim Investigational Site
Englewood, Colorado
511.84.01019 Boehringer Ingelheim Investigational Site
Eugene, Oregon
511.84.01143 Boehringer Ingelheim Investigational Site
Evansville, Indiana
511.84.01074 Boehringer Ingelheim Investigational Site
Fair Oaks, California
511.84.01138 Boehringer Ingelheim Investigational Site
Farmington, Connecticut
511.84.01085 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida
511.84.01194 Boehringer Ingelheim Investigational Site
Fort Meyers, Florida
511.84.01084 Boehringer Ingelheim Investigational Site
Fort Worth, Texas
511.84.01002 Boehringer Ingelheim Investigational Site
Gainesville, Florida
511.84.01069 Boehringer Ingelheim Investigational Site
Gainsville, Florida
511.84.01174 Boehringer Ingelheim Investigational Site
Germantown, Tennessee
511.84.01123 Boehringer Ingelheim Investigational Site
Greenville, South Carolina
511.84.01044 Boehringer Ingelheim Investigational Site
Groton, Connecticut
511.84.01016 Boehringer Ingelheim Investigational Site
Hartford, Connecticut
511.84.01030 Boehringer Ingelheim Investigational Site
Haverhill, Massachusetts
511.84.01057 Boehringer Ingelheim Investigational Site
Houston, Texas
511.84.01082 Boehringer Ingelheim Investigational Site
Houston, Texas
511.84.01198 Boehringer Ingelheim Investigational Site
Houston, Texas
511.84.01007 Boehringer Ingelheim Investigational Site
Hudson, Florida
511.84.01188 Boehringer Ingelheim Investigational Site
Huntsville, Alabama
511.84.01092 Boehringer Ingelheim Investigational Site
Indianapolis, Indiana
511.84.01104 Boehringer Ingelheim Investigational Site
Irvine, California
511.84.01088 Boehringer Ingelheim Investigational Site
Jenkintown, Pennsylvania
511.84.01013 Boehringer Ingelheim Investigational Site
Jonesboro, Arkansas
511.84.01051 Boehringer Ingelheim Investigational Site
Kansas City, Missouri
511.84.01163 Boehringer Ingelheim Investigational Site
Knoxville, Tennessee
511.84.01037 Boehringer Ingelheim Investigational Site
La Jolla, California
511.84.01171 Boehringer Ingelheim Investigational Site
Lafayette, Louisiana
511.84.01148 Boehringer Ingelheim Investigational Site
Las Vegas, Nevada
511.84.01049 Boehringer Ingelheim Investigational Site
Lexington, Kentucky
511.84.01162 Boehringer Ingelheim Investigational Site
Little Rock, Alaska
511.84.01176 Boehringer Ingelheim Investigational Site
Marietta, Georgia
511.84.01134 Boehringer Ingelheim Investigational Site
Medfod, Oregon
511.84.01055 Boehringer Ingelheim Investigational Site
Miami, Florida
511.84.01064 Boehringer Ingelheim Investigational Site
Miami, Florida
511.84.01177 Boehringer Ingelheim Investigational Site
Middleton, Wisconsin
511.84.01110 Boehringer Ingelheim Investigational Site
Mobile, Alabama
511.84.01142 Boehringer Ingelheim Investigational Site
Mobile, Alabama
511.84.01157 Boehringer Ingelheim Investigational Site
Mobile, Alabama
511.84.01206 Boehringer Ingelheim Investigational Site
Moorestown, New Jersey
511.84.01109 Boehringer Ingelheim Investigational Site
Mt. Pleasant, South Carolina
511.84.01026 Boehringer Ingelheim Investigational Site
Nashville, Tennessee
511.84.01100 Boehringer Ingelheim Investigational Site
Nashville, Tennessee
511.84.01121 Boehringer Ingelheim Investigational Site
New Bern, North Carolina
511.84.01108 Boehringer Ingelheim Investigational Site
New Britain, Connecticut
511.84.01010 Boehringer Ingelheim Investigational Site
New Brunswick, New Jersey
511.84.01168 Boehringer Ingelheim Investigational Site
New London, Connecticut
511.84.01130 Boehringer Ingelheim Investigational Site
New Orlean, Louisiana
511.84.01192 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana
511.84.01182 Boehringer Ingelheim Investigational Site
New Port Richey, Florida
511.84.01166 Boehringer Ingelheim Investigational Site
Newark, Delaware
511.84.01107 Boehringer Ingelheim Investigational Site
Norfolk, Virginia
511.84.01125 Boehringer Ingelheim Investigational Site
Norfolk, Virginia
511.84.01167 Boehringer Ingelheim Investigational Site
Ocala, Florida
511.84.01190 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
511.84.01156 Boehringer Ingelheim Investigational Site
Omaha, Nebraska
511.84.01111 Boehringer Ingelheim Investigational Site
Orlando, Florida
511.84.01118 Boehringer Ingelheim Investigational Site
Orlando, Florida
511.84.01135 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida
511.84.01067 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
511.84.01153 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
511.84.01070 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
511.84.01191 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
511.84.01145 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania
511.84.01032 Boehringer Ingelheim Investigational Site
Plantation, Florida
511.84.01103 Boehringer Ingelheim Investigational Site
Portland, Oregon
511.84.01066 Boehringer Ingelheim Investigational Site
Poughkeepsie, New York
511.84.01187 Boehringer Ingelheim Investigational Site
Purchase, New York
511.84.01119 Boehringer Ingelheim Investigational Site
Raleigh, North Carolina
511.84.01141 Boehringer Ingelheim Investigational Site
Renton, Washington
511.84.01076 Boehringer Ingelheim Investigational Site
Richmond, Virginia
511.84.01097 Boehringer Ingelheim Investigational Site
Richmond, Virginia
511.84.01196 Boehringer Ingelheim Investigational Site
Richmond, Virginia
511.84.01038 Boehringer Ingelheim Investigational Site
Rochester, New York
511.84.01139 Boehringer Ingelheim Investigational Site
Roswell, Georgia
511.84.01056 Boehringer Ingelheim Investigational Site
Sacramento, California
511.84.01195 Boehringer Ingelheim Investigational Site
Sacramento, California
511.84.01015 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah
511.84.01036 Boehringer Ingelheim Investigational Site
San Antonio, Texas
511.84.01071 Boehringer Ingelheim Investigational Site
San Antonio, Texas
511.84.01083 Boehringer Ingelheim Investigational Site
San Antonio, Texas
511.84.01086 Boehringer Ingelheim Investigational Site
San Antonio, Texas
511.84.01043 Boehringer Ingelheim Investigational Site
San Diego, California
511.84.01047 Boehringer Ingelheim Investigational Site
San Diego, California
511.84.01096 Boehringer Ingelheim Investigational Site
San Diego, California
511.84.01180 Boehringer Ingelheim Investigational Site
Sandy City, Utah
511.84.01023 Boehringer Ingelheim Investigational Site
Sandy Springs, Georgia
511.84.01175 Boehringer Ingelheim Investigational Site
Sarasota, Florida
511.84.01012 Boehringer Ingelheim Investigational Site
Seattle, Washington
511.84.01116 Boehringer Ingelheim Investigational Site
Spokane, Washington
511.84.01034 Boehringer Ingelheim Investigational Site
St Louis, Missouri
511.84.01053 Boehringer Ingelheim Investigational Site
St. Petersburg, Florida
511.84.01132 Boehringer Ingelheim Investigational Site
St. Petersburg, Florida
511.84.01040 Boehringer Ingelheim Investigational Site
Stanford, California
511.84.01117 Boehringer Ingelheim Investigational Site
Stuart, Florida
511.84.01105 Boehringer Ingelheim Investigational Site
Tacoma, Washington
511.84.01159 Boehringer Ingelheim Investigational Site
Tampa, Florida
511.84.01170 Boehringer Ingelheim Investigational Site
Tampa, Florida
511.84.01183 Boehringer Ingelheim Investigational Site
Tampa, Florida
511.84.01048 Boehringer Ingelheim Investigational Site
Tarzana, California
511.84.01059 Boehringer Ingelheim Investigational Site
The Bronx, New York
511.84.01017 Boehringer Ingelheim Investigational Site
Torrance, California
511.84.01115 Boehringer Ingelheim Investigational Site
Tucson, Arizona
511.84.01112 Planned Parenthood of Arkansas & Estrn Oklahoma, Inc
Tulsa, Oklahoma
511.84.01185 Boehringer Ingelheim Investigational Site
Tulsa, Oklahoma
511.84.01173 Boehringer Ingelheim Investigational Site
Vista, California
511.84.01098 Boehringer Ingelheim Investigational Site
Waco, Texas
511.84.01029 Boehringer Ingelheim Investigational Site
Walnut Creek, California
511.84.01060 Boehringer Ingelheim Investigational Site
Warwick, Rhode Island
511.84.01160 Boehringer Ingelheim Investigational Site
Washington D.C., District of Columbia
511.84.01003 Boehringer Ingelheim Investigational Site
West Palm Beach, Florida
511.84.01022 Boehringer Ingelheim Investigational Site
West Palm Beach, Florida
511.84.01054 Boehringer Ingelheim Investigational Site
West Reading, Pennsylvania
511.84.01137 Boehringer Ingelheim Investigational Site
Westlake Village, California
511.84.01006 Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado
511.84.01202 Boehringer Ingelheim Investigational Site
Wichita, Kansas
511.84.01021 Boehringer Ingelheim Investigational Site
Wilkes-Barre, Pennsylvania
511.84.01072 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina

Other trials in United States

Canada23 sites

511.84.02018 Boehringer Ingelheim Investigational Site
Barrie, Ontario
511.84.02009 Boehringer Ingelheim Investigational Site
Burlington, Ontario
511.84.02007 Boehringer Ingelheim Investigational Site
Calgary, Alberta
511.84.02014 Boehringer Ingelheim Investigational Site
Coquitlam, British Columbia
511.84.02003 Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia
511.84.02022 Boehringer Ingelheim Investigational Site
London, Ontario
511.84.02024 Boehringer Ingelheim Investigational Site
London, Ontario
511.84.02011 Boehringer Ingelheim Investigational Site
Montreal, Quebec
511.84.02012 Boehringer Ingelheim Investigational Site
Mount Pearl, Newfoundland and Labrador
511.84.02002 Boehringer Ingelheim Investigational Site
North Vancouver, British Columbia
511.84.02001 Boehringer Ingelheim Investigational Site
Ottawa, Ontario
511.84.02008 Boehringer Ingelheim Investigational Site
Ottawa, Ontario
511.84.02019 Boehringer Ingelheim Investigational Site
Québec, Quebec
511.84.02020 Boehringer Ingelheim Investigational Site
Québec, Quebec
511.84.02004 Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan
511.84.02005 Boehringer Ingelheim Investigational Site
Sherbrooke, Quebec
511.84.02006 Boehringer Ingelheim Investigational Site
St. John's, Newfoundland and Labrador
511.84.02021 Boehringer Ingelheim Investigational Site
Surrey, British Columbia
511.84.02013 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
511.84.02015 Boehringer Ingelheim Investigational Site
Victoria, British Columbia
511.84.02023 Boehringer Ingelheim Investigational Site
Victoria, British Columbia
511.84.02017 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba
511.84.02010 Boehringer Ingelheim Investigational Site
Woodstock, New Brunswick

Other trials in Canada

About this study

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

Conditions: Sexual Dysfunctions, Psychological
Being tested: Flibanserin
Medical subject headings: Sexual Dysfunctions, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00441558
Study group	Role	What they receive
flibanserin	Experimental	flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily. Receives: Drug: Flibanserin

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2007Aug 2009

First posted1 Mar 2007 (estimated)
Study startFeb 2007
Primary completionAug 2009
Study completionAug 2009

Why it stopped: terminated for administrative reasons

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Sexual Dysfunctions, PsychologicalStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,723 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00441558
Sponsor's protocol ID: 511.84
Status last verified: May 2014
First submitted: 28 Feb 2007
Last updated: 13 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Jayne C, Simon JA, Taylor LV, Kimura T, Lesko LM; SUNFLOWER study investigators. Open-label extension study of flibanserin in women with hypoactive sexual desire disorder. J Sex Med. 2012 Dec;9(12):3180-8. doi: 10.1111/j.1743-6109.2012.02942.x. Epub 2012 Oct 11.
PubMed 23057791

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
The PANHIS Study: Sexual Health in Spanish-Speaking Adults - A Cross-Sectional Online Survey
Sexual Health, Sexual Dysfunction, Physiological
Not yet recruitingPhase 1/2
BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder
Early-stage Breast Cancer, Hypoactive Sexual Desire Disorder
Active, not recruitingPhase 4
Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease
Peyronie Disease, Sexual Dysfunctions, Psychological
Active, not recruiting
Early Psychological Intervention After Rape
Post Traumatic Stress Disorder, Rape Sexual Assault
Active, not recruiting
Sexual Health and Rehabilitation Online (SHAREonline)
Cancer Survivorship, Sexual Function Disturbances

All Sexual Dysfunctions, Psychological trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Worldwide One-year Open-label Safety Study of Flibanserin in Women With HSDD
ClinicalTrials.gov ID: NCT00441558
Acronym / sponsor ID: 511.84
Conditions: Sexual Dysfunctions, Psychological
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: terminated for administrative reasons
Enrolment: 1,723 participants (actual)
Lead sponsor: Sprout Pharmaceuticals, IncIndustry (pharma, biotech, devices)
Study start: Feb 2007
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 1 Mar 2007 (estimated)
Results: Posted 13 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
flibanserin	Experimental	Drug: Flibanserinflexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.

Who may qualify

Ages: 18 to 55 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Flibanserinflexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.	Drug	flibanserin

Primary outcome

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

Results and safety

Results posted to the registry on 13 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Flibanserin	1,723	667

Primary outcome: The Frequency of Adverse Events (Side Effects).

Time frame: 52 weeks. Number. Unit: participants with any adverse event

Measure	Flibanserin n = 1723
Value	1272

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Flibanserin	15 of 1,723 (0.9%)	995 of 1,723 (57.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23057791Jayne C, Simon JA, Taylor LV, Kimura T, Lesko LM; SUNFLOWER study investigators. Open-label extension study of flibanserin in women with hypoactive sexual desire disorder. J Sex Med. 2012 Dec;9(12):3180-8. doi: 10.1111/j.1743-6109.2012.02942.x. Epub 2012 Oct 11.

Related trials for Sexual Dysfunctions, Psychological

RecruitingObservational study
The PANHIS Study: Sexual Health in Spanish-Speaking Adults - A Cross-Sectional Online Survey
Sexual Health, Sexual Dysfunction, Physiological
Not yet recruitingPhase 1/2
BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder
Early-stage Breast Cancer, Hypoactive Sexual Desire Disorder
Active, not recruitingPhase 4
Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease
Peyronie Disease, Sexual Dysfunctions, Psychological
Active, not recruiting
Early Psychological Intervention After Rape
Post Traumatic Stress Disorder, Rape Sexual Assault
Active, not recruiting
Sexual Health and Rehabilitation Online (SHAREonline)
Cancer Survivorship, Sexual Function Disturbances

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

196 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Flibanserin in people with Sexual Dysfunctions, Psychological, run by Sprout Pharmaceuticals, Inc at 196 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 196 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Frequency of Adverse Events (Side Effects). (time frame: 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00441558, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2014; AzTrials last refreshed its copy on 8 Nov 2026.