Sexual Dysfunctions, PsychologicalPhase 3NCT01103362

A 28-week Safety Study of Flibanserin in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder

A Phase 3 study testing flibanserin in people with Sexual Dysfunctions, Psychological, run by Sprout Pharmaceuticals, Inc at 95 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

To generate additional long-term safety and efficacy data on flibanserin in premenopausal women and establish long-term safety and tolerability of flibanserin in naturally postmenopausal women with Hypoactive Sexual Desire Disorder who have completed a prior clinical trial of flibanserin (Trial 511.130, 511.147, or… 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?: No, everyone receives an active treatment
How many people: 596 participants
Where: 95 sitesin 2 countries
Study dates: Apr 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 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Women with primary diagnosis of Hypoactive Sexual Desire Disorder (HSDD) who completed a prior trial of flibanserin. Such completion requires compliance with trial medication and the trial visit schedule including any post-treatment visits required in that clinical trial. Early discontinuation for any reason disqualifies the patient from entry into this trial. Patients must enroll in this study within 7 days after completing the final visit of the parent trial.
The premenopausal patient must use a medically acceptable method of contraception for at least two months before baseline and continue to use medically acceptable method of contraception during the trial.
Postmenopausal patients must be a naturally postmenopausal woman of any age with at least one ovary. Natural menopause is defined as greater than 12 months of spontaneous amenorrhea.
In the investigator's opinion, patients must be willing to adhere to trial requirements 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 sexual functioning with study staff.

Who cannot join

Patients with history of Major Depressive Disorder (MDD) within six months prior to the Screen Visit, or a score of greater than or equal to 14 on the Beck Depression Inventory II (BDI-II), or a history of suicidal behavior or suicidal ideation according to the Columbia-Suicide Severity Rating Scale (C-SSRS®). If a psychiatrist or psychologist, using clinical judgment, believes a patient who scored between 14 and 19 on the BDI®-II is not depressed, the patient may be entered into the trial. NOTE: If a patient reports positive response to BDI®-II Question 9 and/or a Yes response to either C-SSRS® Suicide Ideation section Question 1 and/or 2 and/or any question in the Suicide Behavior section, please refer to Section 5.2.5 for immediate actions required.
At the Screen Visit, serum alanine aminotransferase, serum aspartate aminotransferase, alkaline phosphatase, or total bilirubin greater than or equal to three times upper limit of normal; blood urea nitrogen greater than or equal to 30 mg/deciliter (dL), plasma creatinine greater than or equal to 2 mg/dL, hemoglobin <9.5 grams/dL, leukopenia (<2.5 x 103/microliter [µL]), neutropenia (<1.5 x 103/µL), lymphopenia (<0.8 x 103/µL), thrombocytopenia (<100 x 103/µL) or thrombocytosis (>500 x 103/µL); or random glucose > upper limit of normal.
Patients with newly developed, self-reported symptoms after the End of Treatment parent trial visit and at this trial Screen Visit of pelvic inflammatory disease, urinary tract or vaginal infection / vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy.
Patients with history of any cancer within the last ten years, other than non-invasive, previously resected basal cell carcinoma of the skin.
Patients whose sexual function was affected by hysterectomy, oophorectomy, or any other pelvic or vaginal surgery.
Patients who are pregnant (by urine pregnancy test at the Screen Visit) or have been pregnant within the month prior to the Screen Visit or who are breast-feeding or have breast-fed within the last six months prior to the Baseline Visit.

Show all 9Show fewer

Patients receiving medication excluded in their prior safety and efficacy trial of flibanserin causing sexual dysfunction or safety-relevant interactions (i.e., antidepressants, anxiolytics, antipsychotics, anticonvulsants, anticoagulants).
Patients with clinically relevant conditions which might interfere with their ability to participate in the trial.
Participation in a trial of an investigational medication other than flibanserin within one month prior to the Screen Visit.

Trial locations and contacts

95 sites in 2 countries.

Country

City, postcode or hospital

95 sites in 2 countries

United States88 sites

511.133.01009 Boehringer Ingelheim Investigational Site
Atlanta, Georgia
511.133.01023 Boehringer Ingelheim Investigational Site
Atlanta, Georgia
511.133.01013 Boehringer Ingelheim Investigational Site
Baltimore, Maryland
511.133.01014 Boehringer Ingelheim Investigational Site
Billings, Montana
511.133.01031 Boehringer Ingelheim Investigational Site
Bingham Farms, Michigan
511.133.01074 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
511.133.01141 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
511.133.01003 Boehringer Ingelheim Investigational Site
Boynton Beach, Florida
511.133.01135 Boehringer Ingelheim Investigational Site
Cary, North Carolina
511.133.01084 Boehringer Ingelheim Investigational Site
Chattanooga, Tennessee
511.133.01044 Boehringer Ingelheim Investigational Site
Chicago, Illinois
511.133.01033 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
511.133.01056 Boehringer Ingelheim Investigational Site
Clearwater, Florida
511.133.01004 Boehringer Ingelheim Investigational Site
Cleveland, Ohio
511.133.01050 Boehringer Ingelheim Investigational Site
Columbus, Ohio
511.133.01059 Boehringer Ingelheim Investigational Site
Columbus, Ohio
511.133.01132 Boehringer Ingelheim Investigational Site
Coral Gables, Florida
511.133.01018 Boehringer Ingelheim Investigational Site
Corpus Christi, Texas
511.133.01058 Boehringer Ingelheim Investigational Site
Dayton, Ohio
511.133.01065 Boehringer Ingelheim Investigational Site
Daytona Beach, Florida
511.133.01071 Boehringer Ingelheim Investigational Site
Denver, Colorado
511.133.01072 Boehringer Ingelheim Investigational Site
Edmond, Oklahoma
511.133.01030 Boehringer Ingelheim Investigational Site
Encinitas, California
511.133.01017 Boehringer Ingelheim Investigational Site
Endwell, New York
511.133.01105 Boehringer Ingelheim Investigational Site
Englewood, Ohio
511.133.01007 Boehringer Ingelheim Investigational Site
Eugene, Oregon
511.133.01028 Boehringer Ingelheim Investigational Site
Fair Oaks, California
511.133.01119 Boehringer Ingelheim Investigational Site
Fargo, North Dakota
511.133.01053 Boehringer Ingelheim Investigational Site
Farmington, Connecticut
511.133.01015 Boehringer Ingelheim Investigational Site
Groton, Connecticut
511.133.01032 Boehringer Ingelheim Investigational Site
Houston, Texas
511.133.01046 Boehringer Ingelheim Investigational Site
Huntsville, Alabama
511.133.01034 Boehringer Ingelheim Investigational Site
Indianapolis, Indiana
511.133.01037 Boehringer Ingelheim Investigational Site
Irvine, California
511.133.01011 Boehringer Ingelheim Investigational Site
Katy, Texas
511.133.01063 Boehringer Ingelheim Investigational Site
Knoxville, Tennessee
511.133.01136 Boehringer Ingelheim Investigational Site
La Mesa, California
511.133.01067 Boehringer Ingelheim Investigational Site
Lafayette, Louisiana
511.133.01057 Boehringer Ingelheim Investigational Site
Las Vegas, Nevada
511.133.01082 Boehringer Ingelheim Investigational Site
Marietta, Georgia
511.133.01020 Boehringer Ingelheim Investigational Site
Miami, Florida
511.133.01024 Boehringer Ingelheim Investigational Site
Miami, Florida
511.133.01042 Boehringer Ingelheim Investigational Site
Mobile, Alabama
511.133.01039 Boehringer Ingelheim Investigational Site
Moorestown, New Jersey
511.133.01068 Boehringer Ingelheim Investigational Site
Mt. Pleasant, South Carolina
511.133.01010 Boehringer Ingelheim Investigational Site
Nashville, Tennessee
511.133.01036 Boehringer Ingelheim Investigational Site
Nashville, Tennessee
511.133.01047 Boehringer Ingelheim Investigational Site
New Bern, North Carolina
511.133.01139 Boehringer Ingelheim Investigational Site
New London, Connecticut
511.133.01064 Boehringer Ingelheim Investigational Site
Newark, Delaware
511.133.01128 Boehringer Ingelheim Investigational Site
Newport Beach, California
511.133.01040 Boehringer Ingelheim Investigational Site
Norfolk, Virginia
511.133.01115 Boehringer Ingelheim Investigational Site
Oceanside, California
511.133.01060 Boehringer Ingelheim Investigational Site
Omaha, Nebraska
511.133.01043 Boehringer Ingelheim Investigational Site
Orlando, Florida
511.133.01070 Boehringer Ingelheim Investigational Site
Palm Harbor, Florida
511.133.01025 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
511.133.01073 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
511.133.01055 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania
511.133.01054 Boehringer Ingelheim Investigational Site
Renton, Washington
511.133.01029 Boehringer Ingelheim Investigational Site
Richmond, Virginia
511.133.01075 Boehringer Ingelheim Investigational Site
Richmond, Virginia
511.133.01022 Boehringer Ingelheim Investigational Site
Sacremento, California
511.133.01005 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah
511.133.01012 Boehringer Ingelheim Investigational Site
San Antonio, Texas
511.133.01026 Boehringer Ingelheim Investigational Site
San Antonio, Texas
511.133.01035 Boehringer Ingelheim Investigational Site
San Diego, California
511.133.01052 Boehringer Ingelheim Investigational Site
San Diego, California
511.133.01099 Boehringer Ingelheim Investigational Site
San Diego, California
511.133.01069 Boehringer Ingelheim Investigational Site
Sandy City, Utah
511.133.01008 Boehringer Ingelheim Investigational Site
Sandy Springs, Georgia
511.133.01045 Boehringer Ingelheim Investigational Site
Spokane, Washington
511.133.01006 Boehringer Ingelheim Investigational Site
St Louis, Missouri
511.133.01019 Boehringer Ingelheim Investigational Site
St. Petersburg, Florida
511.133.01038 Boehringer Ingelheim Investigational Site
Tacoma, Washington
511.133.01061 Boehringer Ingelheim Investigational Site
Tampa, Florida
511.133.01066 Boehringer Ingelheim Investigational Site
Tampa, Florida
511.133.01016 Boehringer Ingelheim Investigational Site
Tarzana, California
511.133.01127 Boehringer Ingelheim Investigational Site
Tuscon, Arizona
511.133.01049 Boehringer Ingelheim Investigational Site
Virgnia Beach, Virginia
511.133.01021 Boehringer Ingelheim Investigational Site
Vista, California
511.133.01062 Boehringer Ingelheim Investigational Site
Washington D.C., District of Columbia
511.133.01001 Boehringer Ingelheim Investigational Site
West Palm Beach, Florida
511.133.01002 Boehringer Ingelheim Investigational Site
West Palm Beach, Florida
511.133.01051 Boehringer Ingelheim Investigational Site
Westlake Village, California
511.133.01100 Boehringer Ingelheim Investigational Site
Wichita, Kansas
511.133.01027 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina
511.133.01138 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina

Other trials in United States

Canada7 sites

511.133.02006 Boehringer Ingelheim Investigational Site
Burlington, Ontario
511.133.02004 Boehringer Ingelheim Investigational Site
Calgary, Alberta
511.133.02005 Boehringer Ingelheim Investigational Site
Ottawa, Ontario
511.133.02002 Boehringer Ingelheim Investigational Site
Québec, Quebec
511.133.02003 Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan
511.133.02016 Boehringer Ingelheim Investigational Site
Toronto, Ontario
511.133.02014 Boehringer Ingelheim Investigational Site
Victoria, British Columbia

Other trials in Canada

About this study

Official title: Open-label Extension Trial for Pre- and Postmenopausal Women With HSDD

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
all patients will receive open-label flibanserin 100mg

Study groups in NCT01103362
Study group	Role	What they receive
flibanserin 100mg	Experimental	flibanserin 100mg po qd Receives: Drug: flibanserin

What is being measured

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

The Frequency of Adverse Events
Measured: A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD

Timeline

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

Apr 2010Jan 2011

First posted14 Apr 2010 (estimated)
Study startApr 2010
Primary completionJan 2011
Study completionJan 2011

Why it stopped: 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 596 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01103362
Sponsor's protocol ID: 511.133
Status last verified: Apr 2014
First submitted: 13 Apr 2010
Last updated: 12 May 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Simon JA, Derogatis L, Portman D, Brown L, Yuan J, Kissling R. Flibanserin for Hypoactive Sexual Desire Disorder: An Open-Label Safety Study. J Sex Med. 2018 Mar;15(3):387-395. doi: 10.1016/j.jsxm.2017.12.016.
PubMed 29502984

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 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-label Extension Trial for Pre- and Postmenopausal Women With HSDD
ClinicalTrials.gov ID: NCT01103362
Acronym / sponsor ID: 511.133
Conditions: Sexual Dysfunctions, Psychological
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: administrative reasons
Enrolment: 596 participants (actual)
Lead sponsor: Sprout Pharmaceuticals, IncIndustry (pharma, biotech, devices)
Study start: Apr 2010
Primary completion: Jan 2011 (actual)
Study completion: Jan 2011 (actual)
First posted: 14 Apr 2010 (estimated)
Results: Posted 12 May 2014

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
flibanserin 100mg	Experimental	Drug: flibanserinflibanserin 100mg po qd

Who may qualify

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

Key inclusion criteria (5 listed)

Women with primary diagnosis of Hypoactive Sexual Desire Disorder (HSDD) who completed a prior trial of flibanserin. Such completion requires compliance with trial medication and the trial visit schedule including any post-treatment visits required in that clinical trial. Early discontinuation for any reason disqualifies the patient from entry into this trial. Patients must enroll in this study within 7 days after completing the final visit of the parent trial.
The premenopausal patient must use a medically acceptable method of contraception for at least two months before baseline and continue to use medically acceptable method of contraception during the trial.
Postmenopausal patients must be a naturally postmenopausal woman of any age with at least one ovary. Natural menopause is defined as greater than 12 months of spontaneous amenorrhea.
In the investigator's opinion, patients must be willing to adhere to trial requirements 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 sexual functioning with study staff.

Key exclusion criteria (9 listed)

Patients with history of Major Depressive Disorder (MDD) within six months prior to the Screen Visit, or a score of greater than or equal to 14 on the Beck Depression Inventory II (BDI-II), or a history of suicidal behavior or suicidal ideation according to the Columbia-Suicide Severity Rating Scale (C-SSRS®). If a psychiatrist or psychologist, using clinical judgment, believes a patient who scored between 14 and 19 on the BDI®-II is not depressed, the patient may be entered into the trial. NOTE: If a patient reports positive response to BDI®-II Question 9 and/or a Yes response to either C-SSRS® Suicide Ideation section Question 1 and/or 2 and/or any question in the Suicide Behavior section, please refer to Section 5.2.5 for immediate actions required.
At the Screen Visit, serum alanine aminotransferase, serum aspartate aminotransferase, alkaline phosphatase, or total bilirubin greater than or equal to three times upper limit of normal; blood urea nitrogen greater than or equal to 30 mg/deciliter (dL), plasma creatinine greater than or equal to 2 mg/dL, hemoglobin <9.5 grams/dL, leukopenia (<2.5 x 103/microliter [µL]), neutropenia (<1.5 x 103/µL), lymphopenia (<0.8 x 103/µL), thrombocytopenia (<100 x 103/µL) or thrombocytosis (>500 x 103/µL); or random glucose > upper limit of normal.
Patients with newly developed, self-reported symptoms after the End of Treatment parent trial visit and at this trial Screen Visit of pelvic inflammatory disease, urinary tract or vaginal infection / vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy.
Patients with history of any cancer within the last ten years, other than non-invasive, previously resected basal cell carcinoma of the skin.
Patients whose sexual function was affected by hysterectomy, oophorectomy, or any other pelvic or vaginal surgery.

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
flibanserinall patients will receive open-label flibanserin 100mg	Drug	flibanserin 100mg

Primary outcome

The Frequency of Adverse Events
Time frame: A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD

Results and safety

Results posted to the registry on 12 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 100mg	596	0

Primary outcome: The Frequency of Adverse Events

Time frame: A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD. Number. Unit: percentage of patients-any adverse event

Measure	Flibanserin 100mg n = 596
Value	59.2

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Flibanserin 100mg	4 of 596 (0.7%)	170 of 596 (28.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29502984Simon JA, Derogatis L, Portman D, Brown L, Yuan J, Kissling R. Flibanserin for Hypoactive Sexual Desire Disorder: An Open-Label Safety Study. J Sex Med. 2018 Mar;15(3):387-395. doi: 10.1016/j.jsxm.2017.12.016.

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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

95 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 95 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 5 inclusion and 9 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 12 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 95 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 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 Frequency of Adverse Events (time frame: A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD). 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 NCT01103362, 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 12 May 2014.