Sexual Dysfunctions, PsychologicalPhase 3NCT01057901

Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in North America

A Phase 3 study testing Flibanserin in people with Sexual Dysfunctions, Psychological, run by Sprout Pharmaceuticals, Inc at 100 sites in 2 countries.

Terminated

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

Official record

Search all trials

Trial summary

The objective of this trial is to assess the safety and efficacy of 24-week course of flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in naturally postmenopausal women. Read more about this study

Who is it for?: Ages 35 years and older, women only
Conditions the study is for: Sexual Dysfunctions, Psychological
What is being tested?: Flibanserin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 748 participants
Where: 100 sitesin 2 countries
Study dates: Jan 2010to Jan 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 35 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Naturally postmenopausal women of any age with at least one ovary
Diagnosis of Hypoactive Sexual Desire Disorder, generalized acquired type,of at least six months 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

Show all 9Show fewer

Normal mammogram
Normal uterine lining
Able to comply with daily use of handheld data entry device

Who cannot join

Sexual dysfunctions other than HSDD, such as Sexual Aversion Disorder, Substance-induced Sexual Dysfunction, Dyspareunia, Vaginismus, Gender Identity Disorder, Paraphilia and Sexual Dysfunction due to a General Medical Condition
Partner with inadequately treated organic or psychosexual dysfunction
Sexual function impaired by psychiatric disorder
Sexual function impaired by gynecological disorder
Major Depression
Suicidal behavior or ideation
Major life stress that could impair sexual function
Substance abuse

Trial locations and contacts

100 sites in 2 countries.

Country

City, postcode or hospital

100 sites in 2 countries

United States84 sites

511.156.01039 Boehringer Ingelheim Investigational Site
Anaheim, California
511.156.01048 Boehringer Ingelheim Investigational Site
Anderson, South Carolina
511.156.01077 Boehringer Ingelheim Investigational Site
Ashland, Oregon
511.156.01003 Boehringer Ingelheim Investigational Site
Austin, Texas
511.156.01017 Boehringer Ingelheim Investigational Site
Beachwood, Ohio
511.156.01070 Boehringer Ingelheim Investigational Site
Berkeley, California
511.156.01059 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
511.156.01093 Boehringer Ingelheim Investigational Site
Bismarck, North Dakota
511.156.01066 Boehringer Ingelheim Investigational Site
Boise, Idaho
511.156.01074 Boehringer Ingelheim Investigational Site
Boston, Massachusetts
511.156.01079 Boehringer Ingelheim Investigational Site
Boston, Massachusetts
511.156.01073 Boehringer Ingelheim Investigational Site
Bristol, Tennessee
511.156.01024 Boehringer Ingelheim Investigational Site
Cary, North Carolina
511.156.01065 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina
511.156.01005 Boehringer Ingelheim Investigational Site
Chaska, Minnesota
511.156.01041 Boehringer Ingelheim Investigational Site
Chattanooga, Tennessee
511.156.01025 Boehringer Ingelheim Investigational Site
Chicago, Illinois
511.156.01028 Boehringer Ingelheim Investigational Site
Chicago, Illinois
511.156.01032 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
511.156.01033 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
511.156.01067 Boehringer Ingelheim Investigational Site
Colorado Springs, Colorado
511.156.01056 Boehringer Ingelheim Investigational Site
Columbus, Georgia
511.156.01022 Boehringer Ingelheim Investigational Site
Coral Gables, Florida
511.156.01054 Boehringer Ingelheim Investigational Site
Dallas, Texas
511.156.01042 Boehringer Ingelheim Investigational Site
DeLand, Florida
511.156.01036 Boehringer Ingelheim Investigational Site
Denver, Colorado
511.156.01006 Boehringer Ingelheim Investigational Site
Detroit, Michigan
511.156.01068 Boehringer Ingelheim Investigational Site
Englewood, Ohio
511.156.01052 Boehringer Ingelheim Investigational Site
Fargo, North Dakota
511.156.01092 Boehringer Ingelheim Investigational Site
Fort Collins, Colorado
511.156.01047 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida
511.156.01051 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida
511.156.01050 Boehringer Ingelheim Investigational Site
Fort Worth, Texas
511.156.01011 Boehringer Ingelheim Investigational Site
Gainseville, Florida
511.156.01035 Boehringer Ingelheim Investigational Site
Germantown, Tennessee
511.156.01029 Boehringer Ingelheim Investigational Site
Greensboro, North Carolina
511.156.01058 Boehringer Ingelheim Investigational Site
Greenville, South Carolina
511.156.01080 Boehringer Ingelheim Investigational Site
Haverhill, Massachusetts
511.156.01014 Boehringer Ingelheim Investigational Site
Houston, Texas
511.156.01091 Boehringer Ingelheim Investigational Site
Jackson, Tennessee
511.156.01075 Boehringer Ingelheim Investigational Site
La Mesa, California
511.156.01078 Boehringer Ingelheim Investigational Site
Lake Worth, Florida
511.156.01088 Boehringer Ingelheim Investigational Site
Las Vegas, Nevada
511.156.01008 Boehringer Ingelheim Investigational Site
Lexington, Kentucky
511.156.01063 Boehringer Ingelheim Investigational Site
Little Rock, Arkansas
511.156.01076 Boehringer Ingelheim Investigational Site
Little Rock, Arkansas
511.156.01087 Boehringer Ingelheim Investigational Site
Los Angeles, California
511.156.01045 Boehringer Ingelheim Investigational Site
Marietta, Georgia
511.156.01072 Boehringer Ingelheim Investigational Site
Medford, Oregon
511.156.01060 Boehringer Ingelheim Investigational Site
Memphis, Tennessee
511.156.01001 Boehringer Ingelheim Investigational Site
New Brunswick, New Jersey
511.156.01027 Boehringer Ingelheim Investigational Site
New London, Connecticut
511.156.01034 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana
511.156.01064 Boehringer Ingelheim Investigational Site
Newport Beach, California
511.156.01016 Boehringer Ingelheim Investigational Site
Oceanside, California
511.156.01013 Boehringer Ingelheim Investigational Site
Olive Branch, Mississippi
511.156.01095 Boehringer Ingelheim Investigational Site
Orlando, Florida
511.156.01086 Boehringer Ingelheim Investigational Site
Paw Paw, Michigan
511.156.01082 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
511.156.01055 Boehringer Ingelheim Investigational Site
Plainsboro, New Jersey
511.156.01046 Boehringer Ingelheim Investigational Site
Plantation, Florida
511.156.01037 Boehringer Ingelheim Investigational Site
Poughkeepsie, New York
511.156.01031 Boehringer Ingelheim Investigational Site
Purchase, New York
511.156.01002 Boehringer Ingelheim Investigational Site
Raleigh, North Carolina
511.156.01015 Boehringer Ingelheim Investigational Site
Richmond, Virginia
511.156.01090 Boehringer Ingelheim Investigational Site
Richmond, Virginia
511.156.01021 Boehringer Ingelheim Investigational Site
Roswell, Georgia
511.156.01049 Boehringer Ingelheim Investigational Site
San Antonio, Texas
511.156.01007 Boehringer Ingelheim Investigational Site
San Diego, California
511.156.01038 Boehringer Ingelheim Investigational Site
San Diego, California
511.156.01081 Boehringer Ingelheim Investigational Site
Savannah, Georgia
511.156.01020 Boehringer Ingelheim Investigational Site
Seattle, Washington
511.156.01012 Boehringer Ingelheim Investigational Site
Shreveport, Louisiana
511.156.01089 Boehringer Ingelheim Investigational Site
South Bend, Indiana
511.156.01040 Boehringer Ingelheim Investigational Site
Statesville, North Carolina
511.156.01009 Boehringer Ingelheim Investigational Site
The Bronx, New York
511.156.01084 Boehringer Ingelheim Investigational Site
Tucson, Arizona
511.156.01053 Boehringer Ingelheim Investigational Site
Tuscon, Arizona
511.156.01069 Boehringer Ingelheim Investigational Site
Tuscon, Arizona
511.156.01083 Boehringer Ingelheim Investigational Site
Warwick, Rhode Island
511.156.01085 Boehringer Ingelheim Investigational Site
Watertown, South Dakota
511.156.01094 Boehringer Ingelheim Investigational Site
West Reading, Pennsylvania
511.156.01010 Boehringer Ingelheim Investigational Site
Wichita, Kansas
511.156.01026 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina

Other trials in United States

Canada16 sites

511.156.02013 Boehringer Ingelheim Investigational Site
Barrie, Ontario
511.156.02006 Boehringer Ingelheim Investigational Site
Burlington, Ontario
511.156.02004 Boehringer Ingelheim Investigational Site
Calgary, Alberta
511.156.02010 Boehringer Ingelheim Investigational Site
Coquitlam, British Columbia
511.156.02001 Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia
511.156.02008 Boehringer Ingelheim Investigational Site
Mount Pearl, Newfoundland and Labrador
511.156.02005 Boehringer Ingelheim Investigational Site
Ottawa, Ontario
511.156.02002 Boehringer Ingelheim Investigational Site
Québec, Quebec
511.156.02003 Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan
511.156.02015 Boehringer Ingelheim Investigational Site
Sherbrooke, Quebec
511.156.02016 Boehringer Ingelheim Investigational Site
Toronto, Ontario
511.156.02009 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
511.156.02014 Boehringer Ingelheim Investigational Site
Victoria, British Columbia
511.156.02012 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba
511.156.02017 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba
511.156.02007 Boehringer Ingelheim Investigational Site
Woodstock, New Brunswick

Other trials in Canada

About this study

Official title: 24 - Week Flibanserin 100mg for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in Noth America

The objective of this trial is to assess the safety and efficacy of 24-week course of flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in naturally postmenopausal 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
Flibanserin 100mg administered at bedtime for 24 weeks
PlaceboDrug
This is the matched placebo which will be administered two tablets daily at bedtime.

Study groups in NCT01057901
Study group	Role	What they receive
Flibanserin 100 mg	Experimental	Flibanserin 100 mg administered at bedtime Receives: Drug: Flibanserin
Placebo	Placebo comparator	This is the matched placebo which will be administered two tablets daily at bedtime. Receives: Drug: Placebo

What is being measured

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

Change From Baseline in the Number of Satisfying Sexual Events
The change from baseline in the number of SSE's as measured by the eDiary. The calculation of Satisfying Sexual Event (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.
Measured: baseline to 24 weeks
Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain
The Female Sexual Function Index (FSFI) is a brief, multidimensional, self-administered questionnaire for assessing key domains of sexual function in women. The scale consists of 19 items that assess sexual function over the past four weeks and yields scores in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The two items in the desire domain are scored from 1 to 5 (1 is lowest level of desire and 5 is the highest level of desire). The raw scores of the two 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 (lowest level of desire) to 6.0 (highest level of desire). For the entire instrument, each of the six domains contributes a maximum of 6 points to the total. Scores on the full scale range from a minimum of 2 to a maximum of 36.
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.

Jan 2010Jan 2011

First posted28 Jan 2010 (estimated)
Study startJan 2010
Primary completionJan 2011
Study completionJan 2011

Why it stopped: Study terminated for administrative reasons.

Resources

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

More details

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

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 748 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01057901
Sponsor's protocol ID: 511.156
Status last verified: Jun 2014
First submitted: 25 Jan 2010
Last updated: 17 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Portman DJ, Brown L, Yuan J, Kissling R, Kingsberg SA. Flibanserin in Postmenopausal Women With Hypoactive Sexual Desire Disorder: Results of the PLUMERIA Study. J Sex Med. 2017 Jun;14(6):834-842. doi: 10.1016/j.jsxm.2017.03.258.
PubMed 28583342

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 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 24 - Week Flibanserin 100mg for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in Noth America
ClinicalTrials.gov ID: NCT01057901
Acronym / sponsor ID: 511.156
Conditions: Sexual Dysfunctions, Psychological
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study terminated for administrative reasons.
Enrolment: 748 participants (actual)
Lead sponsor: Sprout Pharmaceuticals, IncIndustry (pharma, biotech, devices)
Study start: Jan 2010
Primary completion: Jan 2011 (actual)
Study completion: Jan 2011 (actual)
First posted: 28 Jan 2010 (estimated)
Results: Posted 17 Jun 2014

Clinical summary

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

The objective of this trial is to assess the safety and efficacy of 24-week course of flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in naturally postmenopausal 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 100 mg administered at bedtime
Placebo	Placebo comparator	Drug: PlaceboThis is the matched placebo which will be administered two tablets daily at bedtime.

Who may qualify

Ages: 35 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Naturally postmenopausal women of any age with at least one ovary
Diagnosis of Hypoactive Sexual Desire Disorder, generalized acquired type,of at least six months 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)

Sexual dysfunctions other than HSDD, such as Sexual Aversion Disorder, Substance-induced Sexual Dysfunction, Dyspareunia, Vaginismus, Gender Identity Disorder, Paraphilia and Sexual Dysfunction due to a General Medical Condition
Partner with inadequately treated organic or psychosexual dysfunction
Sexual function impaired by psychiatric disorder
Sexual function impaired by gynecological disorder
Major Depression

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 100mg administered at bedtime for 24 weeks	Drug	Flibanserin 100 mg
PlaceboThis is the matched placebo which will be administered two tablets daily at bedtime.	Drug	Placebo

Primary outcome

Change From Baseline in the Number of Satisfying Sexual Events
Time frame: baseline to 24 weeks
The change from baseline in the number of SSE's as measured by the eDiary. The calculation of Satisfying Sexual Event (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.
Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain
Time frame: baseline to 24 weeks
The Female Sexual Function Index (FSFI) is a brief, multidimensional, self-administered questionnaire for assessing key domains of sexual function in women. The scale consists of 19 items that assess sexual function over the past four weeks and yields scores in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The two items in the desire domain are scored from 1 to 5 (1 is lowest level of desire and 5 is the highest level of desire). The raw scores of the two 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 (lowest level of desire) to 6.0 (highest level of desire). For the entire instrument, each of the six domains contributes a maximum of 6 points to the total. Scores on the full scale range from a minimum of 2 to a maximum of 36.

Results and safety

Results posted to the registry on 17 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Flibanserin 100 mg	376	116
Placebo	372	126

Primary outcome: Change From Baseline in the Number of Satisfying Sexual Events

Time frame: baseline to 24 weeks. Mean (Standard Deviation). Unit: SSEs/month

Measure	Flibanserin 100 mg n = 346	Placebo n = 335
Value	1.0 (3.3)	0.7 (2.9)

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, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had usable data.

Primary outcome: Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain

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

Measure	Flibanserin 100 mg n = 351	Placebo n = 343
Value	0.6 (0.1)	0.4 (0.1)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Flibanserin 100 mg	6 of 376 (1.6%)	118 of 376 (31.4%)	Not reported
Placebo	4 of 369 (1.1%)	74 of 369 (20.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28583342Portman DJ, Brown L, Yuan J, Kissling R, Kingsberg SA. Flibanserin in Postmenopausal Women With Hypoactive Sexual Desire Disorder: Results of the PLUMERIA Study. J Sex Med. 2017 Jun;14(6):834-842. doi: 10.1016/j.jsxm.2017.03.258.

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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

100 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 100 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 9 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: stopped early, as of the sponsor's last update on 17 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 100 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 17 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

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

What does the primary outcome measure?

Change From Baseline in the Number of Satisfying Sexual Events (time frame: baseline to 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 NCT01057901, 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 17 Jun 2014.