Sexual Dysfunctions, PsychologicalPhase 3NCT00996164

Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder

A Phase 3 study testing Flibanserin in people with Sexual Dysfunctions, Psychological, run by Sprout Pharmaceuticals, Inc at 75 sites in United States.

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

The object of this trial is to assess the safety and efficacy of a 24 week course of flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women. 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?: Yes, some participants may receive a placebo
How many people: 1,090 participants
Where: 75 sitesUnited States
Study dates: Oct 2009to Feb 2011
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

Premenopausal women who are 18 years old and older
Primary diagnosis of hypoactive sexual desire disorder, generalized acquired type according to Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision, at least 24 weeks in duration.
Stable, monogamous heterosexual relationship for at least one year.
Willing to discuss sexual issues.
Willing to engage in sexual activity at least once a month
Normal pap smear
Must use medically acceptable method of contraception
Able to comply with daily use of a handheld entry device

Who cannot join

Patients who have taken any medication in the protocol List of Prohibited Medications within 30 days before the screening visit.
Patients who meet Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision for: Sexual aversion disorder, substance induced sexual dysfunction, Dyspareunia, vaginismus, gender identity disorder, paraphilia, sexual dysfunction do to a general medical condition.
Partner with inadequately treated organic or psychosexual dysfunction
History of Major Depressive Disorder within six months prior to the screening visit or history of suicidal behavior.
Sexual function impaired by psychiatric disorder
Sexual function impaired by gynecological disorder
Major life stress that could impair sexual function
Substance abuse

Trial locations and contacts

75 sites in 1 country.

City, postcode or hospital

75 sites in 1 country

United States75 sites

511.147.01009 Boehringer Ingelheim Investigational Site
Atlanta, Georgia
511.147.01023 Boehringer Ingelheim Investigational Site
Atlanta, Georgia
511.147.01013 Boehringer Ingelheim Investigational Site
Baltimore, Maryland
511.147.01014 Boehringer Ingelheim Investigational Site
Billings, Montana
511.147.01031 Boehringer Ingelheim Investigational Site
Bingham Farms, Michigan
511.147.01074 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
511.147.01003 Boehringer Ingelheim Investigational Site
Boynton Beach, Florida
511.147.01044 Boehringer Ingelheim Investigational Site
Chicago, Illinois
511.147.01033 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
511.147.01056 Boehringer Ingelheim Investigational Site
Clearwater, Florida
511.147.01004 Boehringer Ingelheim Investigational Site
Cleveland, Ohio
511.147.01048 Boehringer Ingelheim Investigational Site
Columbia, South Carolina
511.147.01050 Boehringer Ingelheim Investigational Site
Columbus, Ohio
511.147.01059 Boehringer Ingelheim Investigational Site
Columbus, Ohio
511.147.01018 Boehringer Ingelheim Investigational Site
Corpus Christi, Texas
511.147.01058 Boehringer Ingelheim Investigational Site
Dayton, Ohio
511.147.01065 Boehringer Ingelheim Investigational Site
Daytona Beach, Florida
511.147.01071 Boehringer Ingelheim Investigational Site
Denver, Colorado
511.147.01030 Boehringer Ingelheim Investigational Site
Encinitas, California
511.147.01017 Boehringer Ingelheim Investigational Site
Endwell, New York
511.147.01007 Boehringer Ingelheim Investigational Site
Eugene, Oregon
511.147.01028 Boehringer Ingelheim Investigational Site
Fair Oaks, California
511.147.01053 Boehringer Ingelheim Investigational Site
Farmington, Connecticut
511.147.01015 Boehringer Ingelheim Investigational Site
Groton, Connecticut
511.147.01032 Boehringer Ingelheim Investigational Site
Houston, Texas
511.147.01046 Boehringer Ingelheim Investigational Site
Huntsville, Alabama
511.147.01034 Boehringer Ingelheim Investigational Site
Indianapolis, Indiana
511.147.01037 Boehringer Ingelheim Investigational Site
Irvine, California
511.147.01011 Boehringer Ingelheim Investigational Site
Katy, Texas
511.147.01063 Boehringer Ingelheim Investigational Site
Knoxville, Tennessee
511.147.01067 Boehringer Ingelheim Investigational Site
Lafayette, Louisiana
511.147.01057 Boehringer Ingelheim Investigational Site
Las Vegas, Nevada
511.147.01020 Boehringer Ingelheim Investigational Site
Miami, Florida
511.147.01024 Boehringer Ingelheim Investigational Site
Miami, Florida
511.147.01042 Boehringer Ingelheim Investigational Site
Mobile, Alabama
511.147.01039 Boehringer Ingelheim Investigational Site
Moorestown, New Jersey
511.147.01068 Boehringer Ingelheim Investigational Site
Mt. Pleasant, South Carolina
511.147.01010 Boehringer Ingelheim Investigational Site
Nashville, Tennessee
511.147.01036 Boehringer Ingelheim Investigational Site
Nashville, Tennessee
511.147.01047 Boehringer Ingelheim Investigational Site
New Bern, North Carolina
511.147.01041 Boehringer Ingelheim Investigational Site
New Britain, Connecticut
511.147.01070 Boehringer Ingelheim Investigational Site
New Port Richey, Florida
511.147.01064 Boehringer Ingelheim Investigational Site
Newark, Delaware
511.147.01040 Boehringer Ingelheim Investigational Site
Norfolk, Virginia
511.147.01049 Boehringer Ingelheim Investigational Site
Norfolk, Virginia
511.147.01072 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
511.147.01060 Boehringer Ingelheim Investigational Site
Omaha, Nebraska
511.147.01043 Boehringer Ingelheim Investigational Site
Orlando, Florida
511.147.01025 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
511.147.01073 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
511.147.01055 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania
511.147.01054 Boehringer Ingelheim Investigational Site
Renton, Washington
511.147.01029 Boehringer Ingelheim Investigational Site
Richmond, Virginia
511.147.01075 Boehringer Ingelheim Investigational Site
Richmond, Virginia
511.147.01022 Boehringer Ingelheim Investigational Site
Sacramento, California
511.147.01005 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah
511.147.01012 Boehringer Ingelheim Investigational Site
San Antonio, Texas
511.147.01026 Boehringer Ingelheim Investigational Site
San Antonio, Texas
511.147.01035 Boehringer Ingelheim Investigational Site
San Diego, California
511.147.01052 Boehringer Ingelheim Investigational Site
San Diego, California
511.147.01069 Boehringer Ingelheim Investigational Site
Sandy City, Utah
511.147.01008 Boehringer Ingelheim Investigational Site
Sandy Springs, Georgia
511.147.01045 Boehringer Ingelheim Investigational Site
Spokane, Washington
511.147.01006 Boehringer Ingelheim Investigational Site
St Louis, Missouri
511.147.01019 Boehringer Ingelheim Investigational Site
St. Petersburg, Florida
511.147.01038 Boehringer Ingelheim Investigational Site
Tacoma, Washington
511.147.01061 Boehringer Ingelheim Investigational Site
Tampa, Florida
511.147.01066 Boehringer Ingelheim Investigational Site
Tampa, Florida
511.147.01016 Boehringer Ingelheim Investigational Site
Torrance, California
511.147.01021 Boehringer Ingelheim Investigational Site
Vista, California
511.147.01062 Boehringer Ingelheim Investigational Site
Washington D.C., District of Columbia
511.147.01001 Boehringer Ingelheim Investigational Site
West Palm Beach, Florida
511.147.01002 Boehringer Ingelheim Investigational Site
West Palm Beach, Florida
511.147.01051 Boehringer Ingelheim Investigational Site
Westlake Village, California
511.147.01027 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: A Twenty-four Week, Randomized, Double-blind, Placebo Controlled, Safety and Efficacy Trial of Flibanserin (100 Milligrams) Administered Orally Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder in the United States

The object of this trial is to assess the safety and efficacy of a 24 week course of flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women.

Conditions: Sexual Dysfunctions, Psychological
Being tested: Flibanserin, Placebo
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
patients will be randomized to flibanserin or placebo in a double-blind manner
PlaceboDrug
patients will be randomized to flibanserin or placebo in a double-blind manner

Study groups in NCT00996164
Study group	Role	What they receive
flibanserin 100 mg	Experimental	flibanserin 100mg po qd Receives: Drug: Flibanserin
Placebo	Placebo comparator	placebo 1 tab po qd Receives: Drug: Placebo

What is being measured

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

The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain.
The FSFI is a self-administered questionnaire for assessing key dimensions of sexual function in women. The scale consists of 19 items assessing sexual function over the past 4 weeks and yields scores in 6 domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The 2 items in the desire domain are scored from '1' to '5'. The raw scores of the 2 items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 to 6.0. The higher the score on the desire domain, the higher the level of reported sexual desire.
Measured: 24 weeks
Change From Baseline in the SSE Count From Baseline to 24 Weeks
The change from baseline in the number of Satisfying Sexual Events (SSEs) as measured by the eDiary. The SSEs will be standardized to a 28-day period according to the below formula:
Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered).
"Satisfying" means gratifying, fulfilling, satisfactory, and/or successful for the patient. The partner's satisfaction is not the subject of this question.
An eDiary was used by the patients to record information about sexual events. Patients were instructed to complete the eDiary every morning. When completing an eDiary entry, patients answered questions regarding their sexual events since their last eDiary entry. If patients missed or were late with their eDiary entry, they entered information about their sexual events covering a maximum time period of the past 7 days; however, they did not enter any information beyond the last entry.
Measured: 24 weeks

Timeline

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

Oct 2009Feb 2011

First posted16 Oct 2009 (estimated)
Study startOct 2009
Primary completionDec 2010
Study completionFeb 2011

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.
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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,090 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00996164
Sponsor's protocol ID: 511.147
Status last verified: Apr 2014
First submitted: 15 Oct 2009
Last updated: 19 May 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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?

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Study at a glance

From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Twenty-four Week, Randomized, Double-blind, Placebo Controlled, Safety and Efficacy Trial of Flibanserin (100 Milligrams) Administered Orally Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder in the United States
ClinicalTrials.gov ID: NCT00996164
Acronym / sponsor ID: 511.147
Conditions: Sexual Dysfunctions, Psychological
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,090 participants (actual)
Lead sponsor: Sprout Pharmaceuticals, IncIndustry (pharma, biotech, devices)
Study start: Oct 2009
Primary completion: Dec 2010 (actual)
Study completion: Feb 2011 (actual)
First posted: 16 Oct 2009 (estimated)
Results: Posted 19 May 2014

Clinical summary

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

The object of this trial is to assess the safety and efficacy of a 24 week course of flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
flibanserin 100 mg	Experimental	Drug: Flibanserinflibanserin 100mg po qd
Placebo	Placebo comparator	Drug: Placeboplacebo 1 tab po qd

Who may qualify

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

Key inclusion criteria (8 listed)

Premenopausal women who are 18 years old and older
Primary diagnosis of hypoactive sexual desire disorder, generalized acquired type according to Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision, at least 24 weeks in duration.
Stable, monogamous heterosexual relationship for at least one year.
Willing to discuss sexual issues.
Willing to engage in sexual activity at least once a month

Key exclusion criteria (8 listed)

Patients who have taken any medication in the protocol List of Prohibited Medications within 30 days before the screening visit.
Patients who meet Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision for: Sexual aversion disorder, substance induced sexual dysfunction, Dyspareunia, vaginismus, gender identity disorder, paraphilia, sexual dysfunction do to a general medical condition.
Partner with inadequately treated organic or psychosexual dysfunction
History of Major Depressive Disorder within six months prior to the screening visit or history of suicidal behavior.
Sexual function impaired by psychiatric disorder

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
Flibanserinpatients will be randomized to flibanserin or placebo in a double-blind manner	Drug	flibanserin 100 mg
Placebopatients will be randomized to flibanserin or placebo in a double-blind manner	Drug	Placebo

Primary outcome

The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain.
Time frame: 24 weeks
The FSFI is a self-administered questionnaire for assessing key dimensions of sexual function in women. The scale consists of 19 items assessing sexual function over the past 4 weeks and yields scores in 6 domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The 2 items in the desire domain are scored from '1' to '5'. The raw scores of the 2 items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 to 6.0. The higher the score on the desire domain, the higher the level of reported sexual desire.
Change From Baseline in the SSE Count From Baseline to 24 Weeks
Time frame: 24 weeks
The change from baseline in the number of Satisfying Sexual Events (SSEs) as measured by the eDiary. The SSEs will be standardized to a 28-day period according to the below formula: Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered). "Satisfying" means gratifying, fulfilling, satisfactory, and/or successful for the patient. The partner's satisfaction is not the subject of this question. An eDiary was used by the patients to record information about sexual events. Patients were instructed to complete the eDiary every morning. When completing an eDiary entry, patients answered questions regarding their sexual events since their last eDiary entry. If patients missed or were late with their eDiary entry, they entered information about their sexual events covering a maximum time period of the past 7 days; however, they did not enter any information beyond the last entry.

Results and safety

Results posted to the registry on 19 May 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 100 mg	543	408
Placebo	547	446

Primary outcome: The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain.

Time frame: 24 weeks. Mean (Standard Error). Unit: units on a scale

Measure	Flibanserin 100 mg n = 506	Placebo n = 525
Value	1.0 (0.1)	0.7 (0.1)

Population analysed: The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The treated set was analyzed for safety. The FAS was analyzed for efficacy.

Primary outcome: Change From Baseline in the SSE Count From Baseline to 24 Weeks

Time frame: 24 weeks. Mean (Standard Deviation). Unit: SSEs

Measure	Flibanserin 100 mg n = 500	Placebo n = 521
Value	2.5 (4.6)	1.5 (4.5)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Flibanserin 100 mg	4 of 543 (0.7%)	237 of 543 (43.6%)	Not reported
Placebo	2 of 547 (0.4%)	68 of 547 (12.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

75 sites in 1 country: 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 75 sites in United States.

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 8 inclusion and 8 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 19 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in United States. 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. Some participants in this study may receive a placebo. 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 19 May 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 Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain. (time frame: 24 weeks). The study lists 2 primary outcomes in all. 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 NCT00996164.

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 19 May 2014.