Sexual Dysfunctions, PsychologicalPhase 3NCT00360529

24-week Placebo-controlled Trial of Flibanserin Once Daily 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 54 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

This trial is designed to assess the safety and efficacy of flibanserin in the treatment of premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meets standard diagnostic criteria. Efficacy for flibanserin will be assessed vs. a parallel placebo group. Read more about this study

Who is it for?: Ages 18 years and older, 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: 880 participants
Where: 54 sitesin 2 countries
Study dates: Jul 2006to Apr 2008
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 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Women who are 18 years of age and older.
Premenopausal women having regular menstrual periods who have HSDD (decreased sexual desire), generalized acquired type, according to DSM IV-TR criteria.
Patient must meet minimum cut-off scores on questionnaires relating to sexual functioning and sexual distress.
Patients must be willing to try to have sexual activity (e.g., any act involving direct genital stimulation) at least once monthly.
Patients must be willing and able to use an electronic diary (eDiary) on a daily basis (e.g., have access to a working land line telephone for daily data transmissions).
At the Baseline Visit, patients must have complied with eDiary use adequately.

Show all 11Show fewer

Patients must be in a stable, monogamous, heterosexual relationship that is secure and communicative, for at least 1 year prior to the Screen Visit. The partner is expected to be physically present at least 50% of each month.
Patients must have used a medically acceptable method of contraception for at least 3 months before the Baseline Visit (Visit 2) and continue to use that medically acceptable method of contraception during the trial.
In the investigators opinion, patients must be reliable, honest, compliant, and agree to co-operate with all trial evaluations as well as to be able to perform them.
Patients must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements. Patients must have sufficient understanding to communicate effectively with the investigator, and be willing to discuss their sexual functioning with the investigative staff.
Patients must have a clinically acceptable Pap smear as read by a cytology facility (no evidence of malignancy or squamous intraepithelial lesions) within 6 months before the Screen Visit.

Who cannot join

Patients who have taken any medication noted in the protocols List of Prohibited Medications within 30 days before screening.
Patients whose sexual function was affected (enhanced or worsened) in the investigators opinion by any medication within 30 days before the Screen Visit and anytime prior to the Baseline Visit.
Patients with a history of drug dependence or abuse within the past one year.
Patients with a history of multiple severe reactions (i.e., allergic or oversensitivity to usual doses) to drugs that affect the brain.
Patients with a history of participation in a trial of another investigational medication within one month prior to the Screen Visit, or participation in any previous clinical trial of flibanserin.
Patients who meet accepted diagnostic criteria for sexual disorders that would interfere with improvement in HSDD (sexual aversion, substance-induced sexual problems, urge to live as a man, etc.

Show all 14Show fewer

Patients who indicate that their sexual partner has inadequately treated sexual problems that could interfere with the patients response to treatment.
Patients who have entered the menopausal transition or menopause or have had a hysterectomy.
Patients with findings at the Screen Visit of infection, inflammation, undue tenderness, or shrinkage (atrophy) of the female organs.
Patients who are breast feeding or have breastfed within the last 6 months prior to the Baseline Visit.
Patients who are pregnant or have been pregnant within the last 6 months prior to the Baseline Visit.
Patients with a history of Major Depressive Disorder within 6 months prior the Screen Visit, a score indicating depression on a depression scale, a history of suicide attempt, or current suicidal ideation evident at the Screen or Baseline Visit.
Patients with a history of any other psychiatric disorders that could impact sexual function, risks patients safety, or may impact compliance.
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Trial locations and contacts

54 sites in 2 countries.

Country

City, postcode or hospital

54 sites in 2 countries

United States40 sites

511.71.01030 Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico
511.71.01015 Boehringer Ingelheim Investigational Site
Atlanta, Georgia
511.71.01001 Boehringer Ingelheim Investigational Site
Boynton Beach, Florida
511.71.01045 Boehringer Ingelheim Investigational Site
Brighton, Massachusetts
511.71.01036 Boehringer Ingelheim Investigational Site
Chicago, Illinois
511.71.01002 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
511.71.01044 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
511.71.01032 Boehringer Ingelheim Investigational Site
Clearwater, Florida
511.71.01026 Boehringer Ingelheim Investigational Site
Columbus, Ohio
511.71.01003 Boehringer Ingelheim Investigational Site
Danville, Pennsylvania
511.71.01035 Boehringer Ingelheim Investigational Site
Denver, Colorado
511.71.01039 Boehringer Ingelheim Investigational Site
Edmond, Oklahoma
511.71.01029 Boehringer Ingelheim Investigational Site
Evansville, Indiana
511.71.01020 Boehringer Ingelheim Investigational Site
Germantown, Tennessee
511.71.01010 Boehringer Ingelheim Investigational Site
Groton, Connecticut
511.71.01008 Boehringer Ingelheim Investigational Site
Huntington, West Virginia
511.71.01041 Boehringer Ingelheim Investigational Site
La Mesa, California
511.71.01038 Boehringer Ingelheim Investigational Site
Marietta, Georgia
511.71.01014 Boehringer Ingelheim Investigational Site
Miami, Florida
511.71.01034 Boehringer Ingelheim Investigational Site
Mobile, Alabama
511.71.01022 Boehringer Ingelheim Investigational Site
Mt. Pleasant, South Carolina
511.71.01023 Boehringer Ingelheim Investigational Site
New Bern, North Carolina
511.71.01021 Boehringer Ingelheim Investigational Site
New Britain, Connecticut
511.71.01024 Boehringer Ingelheim Investigational Site
New Orlean, Louisiana
511.71.01037 Boehringer Ingelheim Investigational Site
Newark, Delaware
511.71.01025 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida
511.71.01033 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
511.71.01016 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
511.71.01031 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania
511.71.01006 Boehringer Ingelheim Investigational Site
Plantation, Florida
511.71.01028 Boehringer Ingelheim Investigational Site
Renton, Indiana
511.71.01007 Boehringer Ingelheim Investigational Site
Rochester, New York
511.71.01017 Boehringer Ingelheim Investigational Site
San Antonio, Texas
511.71.01018 Boehringer Ingelheim Investigational Site
San Antonio, Texas
511.71.01011 Boehringer Ingelheim Investigational Site
San Diego, California
511.71.01042 Boehringer Ingelheim Investigational Site
South Birmingham, Alabama
511.71.01005 Boehringer Ingelheim Investigational Site
St Louis, Missouri
511.71.01012 Boehringer Ingelheim Investigational Site
The Bronx, New York
511.71.01040 Boehringer Ingelheim Investigational Site
Towson, Maryland
511.71.01027 Boehringer Ingelheim Investigational Site
Westlake Village, California

Other trials in United States

Canada14 sites

511.71.02004 Boehringer Ingelheim Investigational Site
Burlington, Ontario
511.71.02002 Boehringer Ingelheim Investigational Site
Calgary, Alberta
511.71.02001 Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia
511.71.02006 Boehringer Ingelheim Investigational Site
Kelowna, British Columbia
511.71.02013 Boehringer Ingelheim Investigational Site
London, Ontario
511.71.02005 Boehringer Ingelheim Investigational Site
Montreal, Quebec
511.71.02009 Boehringer Ingelheim Investigational Site
Oshawa, Ontario
511.71.02003 Boehringer Ingelheim Investigational Site
Ottawa, Ontario
511.71.02014 Boehringer Ingelheim Investigational Site
Québec, Quebec
511.71.02011 Boehringer Ingelheim Investigational Site
Surrey, British Columbia
511.71.02007 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
511.71.02008 Boehringer Ingelheim Investigational Site
Victoria, British Columbia
511.71.02012 Boehringer Ingelheim Investigational Site
Victoria, British Columbia
511.71.02010 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba

Other trials in Canada

About this study

Official title: A Twenty Four Week, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Trial of Flibanserin 50mg Every Evening and Flibanserin 100mg Every Evening in Women With Hypoactive Sexual Desire Disorder in North America

Read the detailed description

This trial was designed as a prospective, multicenter trial containing a 24-week, randomized, double blind, placebo controlled, parallel-group period that assessed the effects of flibanserin (maximum total daily dose: 100 mg q.d.) compared with placebo in premenopausal women with HSDD, determined by Diagnostic and Statistical Manual IV- Text Revision (DSM IV-TR®) criteria. Three hundred patients were to be randomized to each treatment group. This trial examined the safety and efficacy of flibanserin compared to placebo for 24 weeks.

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
Also called flibanserin 50 mg, flibanserin 100mg, placebo
flibanserin placebo versus 50 mg qhs versus 100 mg qhs

Study groups in NCT00360529
Study group	Role	What they receive
fibanserin	Experimental	flibanserin 50 mg q.h.s. Receives: Drug: flibanserin
flibanserin	Experimental	flibanserin 100 mg q.h.s. Receives: Drug: flibanserin
placebo	Placebo comparator	placebo q.h.s. Receives: Drug: flibanserin

What is being measured

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

Satisfying Sexual Event Monthly Change From Baseline at Final Visit
Change from baseline in the frequency of sexual satisfying events, as measured via e-Diary, standardized to a 28-day period. Change from baseline is calculated as the difference between the four week baseline period and Week 21 to Week 24.
Measured: Baseline, Week 24
Sexual Desire Monthly Change on Electronic Diary From Baseline at Final Visit
Change from baseline in eDiary Sexual Desire Monthly Total Score standardized to a 28-day period. Change from baseline calculated as the difference between the 4 week baseline period and Week 21 to Week 24. Patients recorded information daily throughout trial. Every time the eDiary was completed, a desire question was asked. If a patient did not complete the diary on a given day, the patient was not asked to enter desire information for more than a 24-hour retrospective period. The desire item read "Indicate your most intense level of sexual desire in the last 24 hours/since your last visit." Potential responses included "no," "low," "moderate," or "strong", scored 0-3 (0 indicating no desire and 3 indicating the highest level of desire):
0 = No desire
1. = Low desire
2. = Moderate desire
3. = Strong desire
Total score ranged from 0-84, with higher scores reflecting stronger desire). Monthly desire score was calculated as 28 x (sum of daily desire scores/number of responses).
Measured: Baseline, Week 24

Secondary outcomes (5)

Female Sexual Distress Scale - Revised (FSDS-R) Total Score Change From Baseline at Final Visit
Change from baseline in the Female Sexual Distress Scale - revised (FSDS-R) Total Score with a seven day recall period.
The FSDS is a measure of female personal distress associated with sexual dysfunction. Reliability and validity of the FSDS (12-item version) has been evaluated in different samples of sexually functional and dysfunctional women. An additional question (Question 13) was added to the validated FSDS© in order to capture distress related to specifically sexual desire so that this domain could be appropriately captured. FSDS plus Question 13 comprises FSDS-R, thus making the FSDS-R a self-administered 13 item questionnaire. The maximum total score of the FSDS-R is '52' (score of minimum of 0 and maximum of 4 for each item) and indicates the maximum level of sexual distress (the higher the score, the higher the level of reported sexual desire).
Measured: Baseline, Week 24
Female Sexual Distress Scale - Revised (FSDS-R) Question 13 Score Change From Baseline at Final Visit
Change from baseline in the FSDS-R Question 13 (Bothered by low sexual desire). The FSDS is a measure of female personal distress associated with sexual dysfunction. Reliability and validity of the FSDS (12-item version) has been evaluated in different samples of sexually functional and dysfunctional women. An additional question (Question 13) was added to the validated FSDS© in order to capture distress related to specifically sexual desire so that this domain could be appropriately captured. FSDS plus Question 13 comprises FSDS-R, thus making the FSDS-R a self-administered 13 item questionnaire. The scoring for item 13 is from 0-4, with 4 indicating the highest level of sexual distress.
Measured: Baseline, Week 24
Female Sexual Functioning Index (FSFI) Desire Domain Score Change From Baseline at Final Visit
Female Sexual Function Inventory (FSFI) Desire Domain assesses sexual desire or interest with 2 questions ranging from 1 (very low) to 5 (very high). The domain total score is multiplied by 0.6 yielding scores ranging from 1.2 to 6 (higher scores = higher level of desire or interest).
Measured: Baseline, Week 24
Female Sexual Functioning Index (FSFI) Total Score Change From Baseline at Final Visit
The FSFI© is a self-administered questionnaire to assess FSD, which consists of 19 questions that are scored from '0' to '5.' The scale contains six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Higher scores indicate higher levels of the domain assessed. The total score is a weighted average of the six domains, each contributing a maximum of 6 points to the total, so the minimum score is 2, while the maximum score of FSFI© is 36.
Measured: Baseline, Week 24
Patient Benefit Evaluation
The Patient Benefit Evaluation is a single question asking the patient whether or not she experienced a meaningful benefit from the study medication during the trial. This question ("Overall, do you believe that you have experienced a meaningful benefit from the study medication?") was asked upon treatment discontinuation.
Measured: Week 24

Timeline

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

Jul 2006Apr 2008

First posted4 Aug 2006 (estimated)
Study startJul 2006
Primary completionApr 2008
Study completionApr 2008

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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 880 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00360529
Sponsor's protocol ID: 511.71
Other IDs: VIOLET
Status last verified: Jun 2016
First submitted: 3 Aug 2006
Last updated: 27 Jun 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Derogatis LR, Komer L, Katz M, Moreau M, Kimura T, Garcia M Jr, Wunderlich G, Pyke R; VIOLET Trial Investigators. Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the VIOLET Study. J Sex Med. 2012 Apr;9(4):1074-85. doi: 10.1111/j.1743-6109.2011.02626.x. Epub 2012 Jan 16.
PubMed 22248038

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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Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2016. 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 50mg Every Evening and Flibanserin 100mg Every Evening in Women With Hypoactive Sexual Desire Disorder in North America
ClinicalTrials.gov ID: NCT00360529
Acronym / sponsor ID: 511.71
Conditions: Sexual Dysfunctions, Psychological
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 880 participants (actual)
Lead sponsor: Sprout Pharmaceuticals, IncIndustry (pharma, biotech, devices)
Study start: Jul 2006
Primary completion: Apr 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 4 Aug 2006 (estimated)
Results: Posted 27 Jun 2016

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
fibanserin	Experimental	Drug: flibanserinflibanserin 50 mg q.h.s.
flibanserin	Experimental	Drug: flibanserinflibanserin 100 mg q.h.s.
placebo	Placebo comparator	Drug: flibanserinplacebo q.h.s.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Women who are 18 years of age and older.
Premenopausal women having regular menstrual periods who have HSDD (decreased sexual desire), generalized acquired type, according to DSM IV-TR criteria.
Patient must meet minimum cut-off scores on questionnaires relating to sexual functioning and sexual distress.
Patients must be willing to try to have sexual activity (e.g., any act involving direct genital stimulation) at least once monthly.
Patients must be willing and able to use an electronic diary (eDiary) on a daily basis (e.g., have access to a working land line telephone for daily data transmissions).

Key exclusion criteria (14 listed)

Patients who have taken any medication noted in the protocols List of Prohibited Medications within 30 days before screening.
Patients whose sexual function was affected (enhanced or worsened) in the investigators opinion by any medication within 30 days before the Screen Visit and anytime prior to the Baseline Visit.
Patients with a history of drug dependence or abuse within the past one year.
Patients with a history of multiple severe reactions (i.e., allergic or oversensitivity to usual doses) to drugs that affect the brain.
Patients with a history of participation in a trial of another investigational medication within one month prior to the Screen Visit, or participation in any previous clinical trial of flibanserin.

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
flibanserinAlso: flibanserin 50 mg, flibanserin 100mg, placeboflibanserin placebo versus 50 mg qhs versus 100 mg qhs	Drug	fibanserin, flibanserin, placebo

Primary outcome

Satisfying Sexual Event Monthly Change From Baseline at Final Visit
Time frame: Baseline, Week 24
Change from baseline in the frequency of sexual satisfying events, as measured via e-Diary, standardized to a 28-day period. Change from baseline is calculated as the difference between the four week baseline period and Week 21 to Week 24.
Sexual Desire Monthly Change on Electronic Diary From Baseline at Final Visit
Time frame: Baseline, Week 24
Change from baseline in eDiary Sexual Desire Monthly Total Score standardized to a 28-day period. Change from baseline calculated as the difference between the 4 week baseline period and Week 21 to Week 24. Patients recorded information daily throughout trial. Every time the eDiary was completed, a desire question was asked. If a patient did not complete the diary on a given day, the patient was not asked to enter desire information for more than a 24-hour retrospective period. The desire item read "Indicate your most intense level of sexual desire in the last 24 hours/since your last visit." Potential responses included "no," "low," "moderate," or "strong", scored 0-3 (0 indicating no desire and 3 indicating the highest level of desire): 0 = No desire 1. = Low desire 2. = Moderate desire 3. = Strong desire Total score ranged from 0-84, with higher scores reflecting stronger desire). Monthly desire score was calculated as 28 x (sum of daily desire scores/number of responses).

5 secondary outcomes

Female Sexual Distress Scale - Revised (FSDS-R) Total Score Change From Baseline at Final Visit
Time frame: Baseline, Week 24
Female Sexual Distress Scale - Revised (FSDS-R) Question 13 Score Change From Baseline at Final Visit
Time frame: Baseline, Week 24
Female Sexual Functioning Index (FSFI) Desire Domain Score Change From Baseline at Final Visit
Time frame: Baseline, Week 24
Female Sexual Functioning Index (FSFI) Total Score Change From Baseline at Final Visit
Time frame: Baseline, Week 24
Patient Benefit Evaluation
Time frame: Week 24

Results and safety

Results posted to the registry on 27 Jun 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	295	234
Flibanserin 50 mg q.h.s.	295	230
Flibanserin 100 mg q.h.s	290	199

Primary outcome: Satisfying Sexual Event Monthly Change From Baseline at Final Visit

Time frame: Baseline, Week 24. Mean (Standard Deviation). Unit: number of events

Measure	Placebo n = 285	Flibanserin 50 mg q.h.s. n = 291	Flibanserin 100 mg q.h.s n = 275
Value	0.8 (3.4)	1.4 (3.6)	1.6 (3.8)

Placebo vs Flibanserin 50 mg q.h.s.: p = 0.0454, Wilcoxon (Mann-Whitney)
Placebo vs Flibanserin 100 mg q.h.s: p = 0.0024, Wilcoxon (Mann-Whitney)

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 FAS was analyzed for efficacy.

Primary outcome: Sexual Desire Monthly Change on Electronic Diary From Baseline at Final Visit

Time frame: Baseline, Week 24. Least squares mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 285	Flibanserin 50 mg q.h.s. n = 291	Flibanserin 100 mg q.h.s n = 275
Value	6.9 (0.9)	8.2 (0.9)	9.1 (1.0)

Placebo vs Flibanserin 50 mg q.h.s.: Mean Difference (Final Values): 1.3 (95% CI -1.0 to 3.7), p = 0.2606, ANCOVA
Placebo vs Flibanserin 100 mg q.h.s: Mean Difference (Final Values): 2.2 (95% CI -0.1 to 4.6), p = 0.066, ANCOVA

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 295 (0%)	87 of 295 (29.5%)	Not reported
Flibanserin 50 mg q.h.s.	2 of 295 (0.7%)	107 of 295 (36.3%)	Not reported
Flibanserin 100 mg q.h.s	3 of 290 (1%)	135 of 290 (46.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22248038Derogatis LR, Komer L, Katz M, Moreau M, Kimura T, Garcia M Jr, Wunderlich G, Pyke R; VIOLET Trial Investigators. Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the VIOLET Study. J Sex Med. 2012 Apr;9(4):1074-85. doi: 10.1111/j.1743-6109.2011.02626.x. Epub 2012 Jan 16.

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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.

Sprout Pharmaceuticals study chair

Sprout Pharmaceuticals

54 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 54 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 11 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 27 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 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. 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 27 Jun 2016). 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?

Satisfying Sexual Event Monthly Change From Baseline at Final Visit (time frame: Baseline, Week 24). 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 NCT00360529, 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 27 Jun 2016.