Sexual Dysfunctions, PsychologicalPhase 3NCT00360243

6-mo. Min Eff Dose of Flibanserin: 25 v 50 mg Bid v 50 mg hs v Pbo in Younger Women in NA

A Phase 3 study testing flibanserin in people with Sexual Dysfunctions, Psychological, run by Sprout Pharmaceuticals, Inc at 81 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

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 meet 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 to 50 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: 1,385 participants
Where: 81 sitesUnited States
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 to 50 years
Women only
No healthy volunteers
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 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 11Show 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.

Trial locations and contacts

81 sites in 1 country.

City, postcode or hospital

81 sites in 1 country

United States81 sites

511.70.01023 Boehringer Ingelheim Investigational Site
Anderson, South Carolina
511.70.01022 Boehringer Ingelheim Investigational Site
Atlanta, Georgia
511.70.01057 Boehringer Ingelheim Investigational Site
Atlanta, Georgia
511.70.01087 Boehringer Ingelheim Investigational Site
Atlanta, Georgia
511.70.01024 Boehringer Ingelheim Investigational Site
Aventura, Florida
511.70.01007 Boehringer Ingelheim Investigational Site
Baton Rouge, Louisiana
511.70.01033 Boehringer Ingelheim Investigational Site
Bellevue, Washington
511.70.01082 Boehringer Ingelheim Investigational Site
Billings, Montana
511.70.01010 Boehringer Ingelheim Investigational Site
Burlington, Vermont
511.70.01070 Boehringer Ingelheim Investigational Site
Carmichael, California
511.70.01060 Boehringer Ingelheim Investigational Site
Champaign, Illinois
511.70.01035 Boehringer Ingelheim Investigational Site
Charleston, South Carolina
511.70.01012 Boehringer Ingelheim Investigational Site
Charlottesville, Virginia
511.70.01058 Boehringer Ingelheim Investigational Site
Chicago, Illinois
511.70.01049 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
511.70.01089 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
511.70.01054 Boehringer Ingelheim Investigational Site
Columbus, Ohio
511.70.01020 Boehringer Ingelheim Investigational Site
Corpus Christi, Texas
511.70.01009 Boehringer Ingelheim Investigational Site
Dallas, Texas
511.70.01075 Boehringer Ingelheim Investigational Site
Dayton, Ohio
511.70.01056 Boehringer Ingelheim Investigational Site
Daytona Beach, Florida
511.70.01064 Boehringer Ingelheim Investigational Site
Denver, Colorado
511.70.01028 Boehringer Ingelheim Investigational Site
Detroit, Michigan
511.70.01081 Boehringer Ingelheim Investigational Site
Detroit, Michigan
511.70.01019 Boehringer Ingelheim Investigational Site
Endwell, New York
511.70.01050 Boehringer Ingelheim Investigational Site
Farmington, Connecticut
511.70.01090 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida
511.70.01027 Boehringer Ingelheim Investigational Site
Gainesville, Florida
511.70.01006 Boehringer Ingelheim Investigational Site
Hartford, Connecticut
511.70.01011 Boehringer Ingelheim Investigational Site
Haverhill, Massachusetts
511.70.01030 Boehringer Ingelheim Investigational Site
Houston, Texas
511.70.01091 Boehringer Ingelheim Investigational Site
Houston, Texas
511.70.01068 Boehringer Ingelheim Investigational Site
Huntsville, Alabama
511.70.01032 Boehringer Ingelheim Investigational Site
Indianapolis, Indiana
511.70.01003 Boehringer Ingelheim Investigational Site
Jonesboro, Arkansas
511.70.01018 Boehringer Ingelheim Investigational Site
Lexington, Kentucky
511.70.01002 Boehringer Ingelheim Investigational Site
Mayfield Heights, Ohio
511.70.01036 Boehringer Ingelheim Investigational Site
Medford, Oregon
511.70.01069 Boehringer Ingelheim Investigational Site
Milwaukee, Wisconsin
511.70.01040 Boehringer Ingelheim Investigational Site
Mobile, Alabama
511.70.01077 Boehringer Ingelheim Investigational Site
Moorestown, New Jersey
511.70.01016 Boehringer Ingelheim Investigational Site
Mount Airy, North Carolina
511.70.01008 Boehringer Ingelheim Investigational Site
Nasville, Tennessee
511.70.01055 Boehringer Ingelheim Investigational Site
New London, Connecticut
511.70.01047 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana
511.70.01079 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana
511.70.01062 Boehringer Ingelheim Investigational Site
New Port Richey, Florida
511.70.01076 Boehringer Ingelheim Investigational Site
New York, New York
511.70.01046 Boehringer Ingelheim Investigational Site
Norfolk, Virginia
511.70.01043 Boehringer Ingelheim Investigational Site
Orlando, Florida
511.70.01084 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida
511.70.01004 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
511.70.01025 Boehringer Ingelheim Investigational Site
Poughkeepsie, New York
511.70.01067 Boehringer Ingelheim Investigational Site
Purchase, New York
511.70.01044 Boehringer Ingelheim Investigational Site
Raleigh, North Carolina
511.70.01026 Boehringer Ingelheim Investigational Site
Redding, California
511.70.01029 Boehringer Ingelheim Investigational Site
Richmond, Virginia
511.70.01071 Boehringer Ingelheim Investigational Site
Richmond, Virginia
511.70.01052 Boehringer Ingelheim Investigational Site
Roswell, Georgia
511.70.01031 Boehringer Ingelheim Investigational Site
Saint Louis, Maryland
511.70.01005 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah
511.70.01013 Boehringer Ingelheim Investigational Site
San Antonio, Texas
511.70.01015 Boehringer Ingelheim Investigational Site
San Diego, California
511.70.01061 Boehringer Ingelheim Investigational Site
Sandy City, Utah
511.70.01048 Boehringer Ingelheim Investigational Site
St. Petersburg, Florida
511.70.01014 Boehringer Ingelheim Investigational Site
Stanford, California
511.70.01042 Boehringer Ingelheim Investigational Site
Stuart, Florida
511.70.01039 Boehringer Ingelheim Investigational Site
Tacoma, Washington
511.70.01063 Boehringer Ingelheim Investigational Site
Tampa, Florida
511.70.01085 Boehringer Ingelheim Investigational Site
Tampa, Florida
511.70.01017 Boehringer Ingelheim Investigational Site
Tarzana, California
511.70.01072 Boehringer Ingelheim Investigational Site
Torrance, California
511.70.01041 Boehringer Ingelheim Investigational Site
Tucson, Arizona
511.70.01065 Boehringer Ingelheim Investigational Site
Tulsa, Oklahoma
511.70.01083 Boehringer Ingelheim Investigational Site
Tulsa, Oklahoma
511.70.01078 Boehringer Ingelheim Investigational Site
Vista, California
511.70.01066 Boehringer Ingelheim Investigational Site
Walnut Creek, California
511.70.01073 Boehringer Ingelheim Investigational Site
Warwick, Rhode Island
511.70.01086 Boehringer Ingelheim Investigational Site
West Palm Beach, Florida
511.70.01021 Boehringer Ingelheim Investigational Site
West Reading, Pennsylvania
511.70.01001 Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado

Other trials in United States

About this study

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
Experimental: flibanserin 25 mg b.i.d
flibanserinDrug
Experimental: flibanserin 50mg qhs
flibanserinDrug
Experimental: flibanserin 50mg b.i.d.
placeboDrug
placebo

Study groups in NCT00360243
Study group	Role	What they receive
flibanserin 25 mg b.i.d	Experimental	25 mg twice daily for 24 weeks Receives: Drug: flibanserin
flibanserin 50mg qhs	Experimental	50 mg taken once daily at bedtime for 24 weeks Receives: Drug: flibanserin
flibanserin 50mg b.i.d.	Experimental	50 mg twice daily for 24 weeks Receives: Drug: flibanserin
placebo	Placebo comparator	twice daily for 24 weeks Receives: Drug: placebo

What is being measured

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

Mean Change From Baseline to 24 Weeks in the Frequency of Satisfying Sexual Events as Measured by the eDiary.
A small personal handheld electronic device (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
Change From Baseline to 24 Weeks in Responses to the eDiary Daily Desire Question.
Change from baseline in the electronic diary (eDiary) Sexual Desire Monthly Total Score standardized to a 28-day period (total score range 0-84). Change from baseline is calculated as the difference between the four week baseline period and Week 21 to Week 24. Patients were asked to record information daily in the eDiary throughout the 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" and was scored 0-3, with 0 indicating no desire and 3 indicating the highest level of desire:
0 = No desire
1. = Low desire
2. = Moderate desire
3. = Strong desire
Measured: baseline to 24 weeks

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.
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: 1,385 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00360243
Sponsor's protocol ID: 511.70
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

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 27 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 6-mo. Min Eff Dose of Flibanserin: 25 v 50 mg Bid v 50 mg hs v Pbo in Younger Women in NA
ClinicalTrials.gov ID: NCT00360243
Acronym / sponsor ID: 511.70
Conditions: Sexual Dysfunctions, Psychological
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,385 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
flibanserin 25 mg b.i.d	Experimental	Drug: flibanserin25 mg twice daily for 24 weeks
flibanserin 50mg qhs	Experimental	Drug: flibanserin50 mg taken once daily at bedtime for 24 weeks
flibanserin 50mg b.i.d.	Experimental	Drug: flibanserin50 mg twice daily for 24 weeks
placebo	Placebo comparator	Drug: placebotwice daily for 24 weeks

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: 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 on a daily basis (e.g., have access to a working land line telephone for daily data transmissions).

Key exclusion criteria (11 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
flibanserinExperimental: flibanserin 25 mg b.i.d	Drug	flibanserin 25 mg b.i.d
flibanserinExperimental: flibanserin 50mg qhs	Drug	flibanserin 50mg qhs
flibanserinExperimental: flibanserin 50mg b.i.d.	Drug	flibanserin 50mg b.i.d.
placeboplacebo	Drug	placebo

Primary outcome

Mean Change From Baseline to 24 Weeks in the Frequency of Satisfying Sexual Events as Measured by the eDiary.
Time frame: 24 weeks
A small personal handheld electronic device (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.
Change From Baseline to 24 Weeks in Responses to the eDiary Daily Desire Question.
Time frame: baseline to 24 weeks
Change from baseline in the electronic diary (eDiary) Sexual Desire Monthly Total Score standardized to a 28-day period (total score range 0-84). Change from baseline is calculated as the difference between the four week baseline period and Week 21 to Week 24. Patients were asked to record information daily in the eDiary throughout the 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" and was scored 0-3, with 0 indicating no desire and 3 indicating the highest level of desire: 0 = No desire 1. = Low desire 2. = Moderate desire 3. = Strong desire

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
Flibanserin 25 mg b.i.d	337	235
Flibanserin 50mg Qhs	363	243
Flibanserin 50mg b.i.d.	336	180
Placebo	349	224

Primary outcome: Mean Change From Baseline to 24 Weeks in the Frequency of Satisfying Sexual Events as Measured by the eDiary.

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

Measure	Flibanserin 25 mg b.i.d n = 320	Flibanserin 50mg Qhs n = 334	Flibanserin 50mg b.i.d. n = 291	Placebo n = 325
Value	1.5 (3.4)	1.6 (4.2)	1.6 (3.5)	1.6 (4.3)

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: Change From Baseline to 24 Weeks in Responses to the eDiary Daily Desire Question.

Time frame: baseline to 24 weeks. Least squares mean (Standard Error). Unit: units on a scale

Measure	Flibanserin 25 mg b.i.d n = 320	Flibanserin 50mg Qhs n = 334	Flibanserin 50mg b.i.d. n = 291	Placebo n = 325
Value	8.8 (0.9)	7.0 (0.9)	7.7 (0.9)	7.5 (0.9)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Flibanserin 25 mg b.i.d	1 of 337 (0.3%)	107 of 337 (31.8%)	Not reported
Flibanserin 50mg Qhs	3 of 363 (0.8%)	126 of 363 (34.7%)	Not reported
Flibanserin 50mg b.i.d.	1 of 336 (0.3%)	243 of 336 (72.3%)	Not reported
Placebo	1 of 349 (0.3%)	78 of 349 (22.3%)	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.

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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

81 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 81 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 11 inclusion and 11 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 81 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 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?

Mean Change From Baseline to 24 Weeks in the Frequency of Satisfying Sexual Events as Measured by the eDiary. (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 NCT00360243.

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; AzTrials last refreshed its copy on 7 Nov 2026.