Sexual Dysfunctions, PsychologicalPhase 3NCT00277914

Flibanserin Randomized Withdrawal Trial in Pre-menopausal Women

A Phase 3 study testing Flibanserin in people with Sexual Dysfunctions, Psychological, run by Sprout Pharmaceuticals, Inc at 65 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To estimate the duration of efficacy with continued treatment of double-blind flibanserin or placebo over twenty-four weeks of treatment. Read more about this study

Who is it for?: Ages 18 to 45 years, women only
Conditions the study is for: Sexual Dysfunctions, Psychological
What is being tested?: Flibanserin
How many people: 749 participants
Where: 65 sitesin 2 countries
Study dates: Jan 2006to Jul 2007
Phase: Phase 3
Are there results?: None posted in the registry

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 45 years
Women only
No healthy volunteers
Adult

Who may be able to join

Women over 18 and pre-menopausal
FSDS-R above 14
Willingness to try to have sexual activity at least monthly
Willingness to use an electronic diary daily
Stable, monogamous, heterosexual relationship for at least one year
Medically acceptable method of contraception

Who cannot join

Clinically relevant conditions which might interfere with the patient's abil ity to participate in the trial
Specified medications
Sexual function affected by medication
Drug dependence or abuse
Sexual partner needing treatment
Peri-Menopause or Menopause (surgical or otherwise)

Show all 14Show fewer

Pregnancy
Pelvic Inflammatory Disease
Major depressive Episode
Significant ECG abnormalities
Significant Neurologic findings
Significant GI, Hepatic, Cardiovascular, Renal, Hematologic, Immunologic or Respiratory findings
Uncorrected thyroid or endocrine disease
Uncontrolled Glaucoma

Trial locations and contacts

65 sites in 2 countries.

Country

City, postcode or hospital

65 sites in 2 countries

United States55 sites

511.74.01017 Boehringer Ingelheim Investigational Site
Anderson, South Carolina
511.74.01030 Boehringer Ingelheim Investigational Site
Ann Arbor, Michigan
511.74.01022 Boehringer Ingelheim Investigational Site
Aurora, Colorado
511.74.01007 Boehringer Ingelheim Investigational Site
Baton Rouge, Louisiana
511.74.01012 Boehringer Ingelheim Investigational Site
Billings, Montana
511.74.01056 Boehringer Ingelheim Investigational Site
Bingham Farms, Michigan
511.74.01051 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
511.74.01047 Boehringer Ingelheim Investigational Site
Champaign, Illinois
511.74.01021 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
511.74.01042 Boehringer Ingelheim Investigational Site
Columbus, Ohio
511.74.01039 Boehringer Ingelheim Investigational Site
Coral Gables, Florida
511.74.01046 Boehringer Ingelheim Investigational Site
Denver, Colorado
511.74.01050 Boehringer Ingelheim Investigational Site
Edmond, Oklahoma
511.74.01006 Boehringer Ingelheim Investigational Site
Eugene, Oregon
511.74.01038 Boehringer Ingelheim Investigational Site
Evansville, Indiana
511.74.01019 Boehringer Ingelheim Investigational Site
Gainesville, Florida
511.74.01002 Boehringer Ingelheim Investigational Site
Groton, Connecticut
511.74.01044 Boehringer Ingelheim Investigational Site
Hollywood, Florida
511.74.01001 Boehringer Ingelheim Investigational Site
Hudson, Florida
511.74.01004 Boehringer Ingelheim Investigational Site
Jonesboro, Arkansas
511.74.01057 Boehringer Ingelheim Investigational Site
Knoxville, Tennessee
511.74.01041 Boehringer Ingelheim Investigational Site
Las Vegas, Nevada
511.74.01014 Boehringer Ingelheim Investigational Site
Lexington, Kentucky
511.74.01053 Boehringer Ingelheim Investigational Site
Little Rock, Arkansas
511.74.01034 Boehringer Ingelheim Investigational Site
Medford, Oregon
511.74.01023 Boehringer Ingelheim Investigational Site
Middlebury, Connecticut
511.74.01049 Boehringer Ingelheim Investigational Site
Milwaukee, Wisconsin
511.74.01027 Boehringer Ingelheim Investigational Site
Mobile, Alabama
511.74.01008 Boehringer Ingelheim Investigational Site
Nashville, Tennessee
511.74.01035 Boehringer Ingelheim Investigational Site
Newark, Delaware
511.74.01026 Boehringer Ingelheim Investigational Site
Norfolk, Virginia
511.74.01045 Boehringer Ingelheim Investigational Site
Omaha, Nebraska
511.74.01033 Boehringer Ingelheim Investigational Site
Palm Springs, California
511.74.01003 Boehringer Ingelheim Investigational Site
Palo Alto, California
511.74.01043 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida
511.74.01040 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania
511.74.01016 Boehringer Ingelheim Investigational Site
Plano, Texas
511.74.01018 Boehringer Ingelheim Investigational Site
Poughkeepsie, New York
511.74.01055 Boehringer Ingelheim Investigational Site
Reno, Nevada
511.74.01037 Boehringer Ingelheim Investigational Site
Renton, Washington
511.74.01011 Boehringer Ingelheim Investigational Site
Rochester, New York
511.74.01024 Boehringer Ingelheim Investigational Site
Rockland, Maine
511.74.01036 Boehringer Ingelheim Investigational Site
Roswell, Georgia
511.74.01015 Boehringer Ingelheim Investigational Site
Sacramento, California
511.74.01005 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah
511.74.01020 Boehringer Ingelheim Investigational Site
San Antonio, Texas
511.74.01013 Boehringer Ingelheim Investigational Site
San Diego, California
511.74.01029 Boehringer Ingelheim Investigational Site
Scottsdale, Arizona
511.74.01028 Boehringer Ingelheim Investigational Site
Spokane, Washington
511.74.01010 Boehringer Ingelheim Investigational Site
St Louis, Missouri
511.74.01032 Boehringer Ingelheim Investigational Site
St. Petersburg, Florida
511.74.01052 Boehringer Ingelheim Investigational Site
Torrance, California
511.74.01031 Boehringer Ingelheim Investigational Site
Tucson, Arizona
511.74.01009 Boehringer Ingelheim Investigational Site
West Hartford, Connecticut
511.74.01048 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina

Other trials in United States

Canada10 sites

511.74.02011 Boehringer Ingelheim Investigational Site
Coquitlam, British Columbia
511.74.02004 Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia
511.74.02009 Boehringer Ingelheim Investigational Site
Kelowna, British Columbia
511.74.02010 Boehringer Ingelheim Investigational Site
Kingston, Ontario
511.74.02008 Boehringer Ingelheim Investigational Site
Montreal, Quebec
511.74.02003 Boehringer Ingelheim Investigational Site
Oakville, Ontario
511.74.02002 Boehringer Ingelheim Investigational Site
Ottawa, Ontario
511.74.02007 Boehringer Ingelheim Investigational Site
Ottawa, Ontario
511.74.02006 Boehringer Ingelheim Investigational Site
St. John's, Newfoundland and Labrador
511.74.02012 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba

Other trials in Canada

About this study

Official title: 12-month Sustained Efficacy of Flibanserin v Placebo n Younger Women With HSDD in NA

To estimate the duration of efficacy with continued treatment of double-blind flibanserin or placebo over twenty-four weeks of treatment.

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
flibanserin flexible dosing

What is being measured

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

Duration of efficacy of flibanserin in Sexually Satisfying Events
Measured: 24 weeks

Timeline

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

Jan 2006Jul 2007

First posted18 Jan 2006 (estimated)
Study startJan 2006
Primary completionJul 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: 749 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00277914
Sponsor's protocol ID: 511.74
Status last verified: Mar 2012
First submitted: 16 Jan 2006
Last updated: 16 Mar 2012
Results posted: No

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

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NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
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All Sexual Dysfunctions, Psychological trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 12-month Sustained Efficacy of Flibanserin v Placebo n Younger Women With HSDD in NA
ClinicalTrials.gov ID: NCT00277914
Acronym / sponsor ID: 511.74
Conditions: Sexual Dysfunctions, Psychological
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 749 participants (actual)
Lead sponsor: Sprout Pharmaceuticals, IncIndustry (pharma, biotech, devices)
Study start: Jan 2006
Primary completion: Jul 2007 (actual)
First posted: 18 Jan 2006 (estimated)
Results: Not posted in the source record

Clinical summary

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

To estimate the duration of efficacy with continued treatment of double-blind flibanserin or placebo over twenty-four weeks of treatment.

Study design

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

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Women over 18 and pre-menopausal
FSDS-R above 14
Willingness to try to have sexual activity at least monthly
Willingness to use an electronic diary daily
Stable, monogamous, heterosexual relationship for at least one year

Key exclusion criteria (14 listed)

Clinically relevant conditions which might interfere with the patient's abil ity to participate in the trial
Specified medications
Sexual function affected by medication
Drug dependence or abuse
Sexual partner needing treatment

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
Flibanserinflibanserin flexible dosing	Drug	–

Primary outcome

Duration of efficacy of flibanserin in Sexually Satisfying Events
Time frame: 24 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2012.

Related trials for Sexual Dysfunctions, Psychological

Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Not yet recruiting
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
HIV Testing, STI
Recruiting
Platelet-Rich Plasma for Erectile Dysfunction After Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction
Not yet recruitingPhase 4
NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
HIV Infections, Opioid Use Disorder
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction

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

65 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 65 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 6 inclusion and 14 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: finished, as of the sponsor's last update on 16 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Duration of efficacy of flibanserin in Sexually Satisfying Events (time frame: 24 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 NCT00277914.

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 16 Mar 2012.