Sexual Dysfunctions, PsychologicalPhase 3NCT01040208

12 Week Safety Trial of Flibanserin in Depressed Women Taking an SSRI or SNRI With Decreased Sexual Desire and Distress

A Phase 3 study testing flibanserin 50 mg to 100 mg qhs and flibanserin 100 mg qhs in people with Sexual Dysfunctions, Psychological and Depression, run by Sprout Pharmaceuticals, Inc at 42 sites in United States.

Terminated

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

Official record

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Trial summary

The current trial will explore the safety of flibanserin in combination with Selective Serotonin Reuptake Inhibitors or Norepinephrine Serotonin Reuptake Inhibitors in a representative population of women with depressive and possible concurrent anxiety symptomatology. Read more about this study

Who is it for?: Ages 18 to 50 years, women only
Conditions the study is for: Sexual Dysfunctions, Psychological, Depression
What is being tested?: flibanserin 50 mg to 100 mg qhs and flibanserin 100 mg qhs
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 111 participants
Where: 42 sitesUnited States
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 18 to 50 years
Women only
No healthy volunteers
Adult

Who may be able to join

Women 18-50 years of age, not postmenopausal at the Screen Visit
Women with mild/remitted depressive disorder with score of <11 on the Quick Inventory of Depressive Symptoms Self Report and <16 on the Beck Anxiety Inventory at Screen/Baseline Visits
Women with decreased sexual desire and distress present at least 4 weeks at Screen Visit as determined by the Clinical Interview for Female Sexual Dysfunction-Depression and Diagnostic and Statistical Manual IV-Text Revision (DSM IV-TR)
Score of 15 or higher on the Female Sexual Distress Scale-Revised at Screen/Baseline Visits
Score of 9 or lower on the Changes in Sexual Functioning Questionnaire-Female desire/interest item at Screen/Baseline Visits
Patients must be taking the same Selective Serotonin Reuptake Inhibitor or Norepinephrine Serotonin Reuptake Inhibitor for 3 months and be on a stable dose at least 2 months before the Screen Visit and remain on this regimen during the trial and for 1 month after trial completion

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Patients must have had no treatment for Female Sexual Dysfunction 2 months before Screen Visit
Patients must use medically accepted contraception method
Patients must be in a secure, stable, monogamous, heterosexual relationship at least 12 months prior to Screen Visit, according to the Clinical Interview for Female Sexual Dysfunction-Depression

Who cannot join

Conditions which may interfere with the ability to participate include, but are not limited to:
Patients who have taken any Prohibited Medications within 30 days before Baseline Visit
Patients with history of drug dependence/abuse (including alcohol) within past year
Patients with history of participation in a trial of another investigational drug within 1 month prior to the Screen Visit, or participation in previous flibanserin study
Women with lifelong decreased sexual desire (or Hypoactive Sexual Desire Disorder), Female Sexual Arousal Disorder and/or Female Orgasmic Disorder, per DSM IV-TR criteria
Patients who meet DSM IV-TR criteria for Sexual Aversion Disorder, Substance-Induced Sexual Dysfunction other than Selective Serotonin Reuptake Inhibitor/Norepinephrine Serotonin Reuptake Inhibitor-Induced Sexual Dysfunction, Dyspareunia, Vaginismus, Gender Identity Disorder, Paraphilia, or Sexual Dysfunction Due to a General Medical Condition

Show all 15Show fewer

Patients who have had a hysterectomy, or are in the post menopause stage (i.e., bilateral oophorectomy, chemically induced menopause)
Patients with history of pelvic inflammatory disease, urinary tract, vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, significant vaginal atrophy in the 4 weeks before the Screen Visit
Patients who are breastfeeding or have breastfed within 6 months prior to the Baseline Visit.
Patients who are pregnant (by serum pregnancy test) or have been pregnant within 6 months prior to the Baseline Visit
Patients with current Depressive Disorder (may have concurrent mild Anxiety Disorder) not adequately controlled during the last 2 months and/or with a score of <11 on the Quick Inventory of Depressive Symptoms Self Report and/or a score of <16 on the Beck Anxiety Inventory at Screen and/or Baseline Visits
Patients with history of suicide attempt within the last year or current suicidal ideation. Investigator must assess history of suicidality to determine if patient is at risk before entering the trial
Patients with history of other psychiatric disorders that could impact sexual function, risks patient safety, or may impact compliance. Axis I disorders (except anxiety symptoms and disorders) are excluded. Axis II disorders are allowed
Patients with significant cardiac, neurologic, hepatic, renal, hematologic, respiratory, gastrointestinal, immunological, endocrine disease
Patients with history of breast cancer or other cancer within the last 5 years, other than non-invasive, previously resected skin cancer

Trial locations and contacts

42 sites in 1 country.

City, postcode or hospital

42 sites in 1 country

United States42 sites

Albuquerque Neuroscience
Albuquerque, New Mexico, 87109
Ali Kashfi
Altamonte Springs, Florida, 32701
Atlanta Institute of Medicine & Research
Atlanta, Georgia, 30328
Comprehensive Neuroscience
Atlanta, Georgia, 30328
Future Search Trials
Austin, Texas, 78756
Sheppard Pratt Hospital
Baltimore, Maryland, 21285
Social Psychiatry Research Institute
Brooklyn, New York, 11235
Neurobehavioral Research
Cedarhurst, New York, 11516
Chicago Research Center
Chicago, Illinois, 60634
University of Cincinnati
Cincinnati, Ohio, 45219
Clinical Innovations
Costa Mesa, California, 92636
Millennium Psychiatric Associates
Creve Coeur, Missouri, 63141
MIdwest Clinical Research Center
Dayton, Ohio, 45408
Western Affiliated Research Institute
Denver, Colorado, 80204
Radiant Research
Denver, Colorado, 80239
Gulf Coast Clinical Research
Fort Myers, Florida, 33912
Mood & Anxiety Research
Fresno, California, 93720
Sarkis Clinical Trials
Gainesville, Florida, 32607
ActivMed Practices and Research
Haverhill, Massachusetts, 01830
Mary Ann Knesevich
Irving, Texas, 75062
Clinical Neuroscience Solutions
Jacksonville, Florida, 32216
Capstone Clinical Research
Livertyville, Illinois, 60048
Suburban Research Associates
Media, Pennsylvania, 19063
Clinical Neuroscience Solutions
Memphis, Tennessee, 38119
Bioscience Research
Mount Kisco, New York, 10549
Synergy Clinical Research Center
National City, California, 91950
Medical and Behavioral Health Research
New York, New York, 10023
IPS Research Company
Oklahoma City, Oklahoma, 73103
Clinical Neuroscience Solutions
Orlando, Florida, 32806
CRI Worldwide
Philadelphia, Pennsylvania, 19139
Clinical Trials Technology
Prairie Village, Kansas, 66206
Alliance Research Group
Richmond, Virginia, 23230
Clinical Innovations
Riverside, California, 92506
Clinical Trials of Texas
San Antonio, Texas, 78229
San Antonio Psychiatric Research Center
San Antonio, Texas, 78240
Schuster Medical Research
Sherman Oaks, California, 91403
Psychiatric Medicine Associates
Skokie, Illinois, 60076
Stedman Clinical Trials
Tampa, Florida, 33613
Clinco
Terre Haute, Indiana, 47802
Bio Behavioral Health
Toms River, New Jersey, 08755
Diablo Clinical Research
Walnut Creek, California, 94598
Kolin Research Group
Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: Safety of Flibanserin Versus Placebo in Women Taking a Selective Serotonin Reuptake Inhibitor or Norepinephrine Serotonin Reuptake Inhibitor With Decreased Sexual Desire

Conditions: Sexual Dysfunctions, Psychological, Depression
Being tested: flibanserin 50 mg to 100 mg qhs, flibanserin 100 mg qhs, placebo 2 tablets qhs
Medical subject headings: Sexual Dysfunctions, Psychological, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

flibanserin 50 mg to 100 mg qhsDrug
50 to 100mg qhs
flibanserin 100 mg qhsDrug
100mg qhs
placebo 2 tablets qhsDrug
50 mg placebo

Study groups in NCT01040208
Study group	Role	What they receive
flibanserin 50 mg to 100 mg qhs	Experimental	Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs Receives: Drug: flibanserin 50 mg to 100 mg qhs
flibanserin 100 mg qhs	Experimental	Patient to receive 2 flibanserin tablets of 50 mg qhs Receives: Drug: flibanserin 100 mg qhs
placebo 2 tablets qhs	Experimental	Patient to receive 2 placebo tablets of 50 mg qhs Receives: Drug: placebo 2 tablets qhs

What is being measured

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

The Primary Safety Endpoint is the Occurrence of Adverse Events During the Treatment and Post Treatment Period.
Measured: 17 weeks

Secondary outcomes (2)

The Occurrence of Mild Depressive Symptoms (i.e., a Total Score of '7' to '11', Inclusive) That Have Remitted (i.e., a Total Score of '6' or Less) on the 16 Item Quick Inventory of Depressive Symptoms - Self Report at Visit 6 (Week 12)
Measured: 12 weeks
The Occurrence of Mild Anxiety Symptoms (i.e., a Total Score of '8' to '16', Inclusive) That Have Remitted (i.e., a Total Score of '7' or Less) on the Beck Anxiety Inventory at Visit 6 (Week 12)
Measured: 12 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 posted29 Dec 2009 (estimated)
Study startJan 2010
Primary completionJan 2011
Study completionJan 2011

Why it stopped: Study terminated by Sponsor for administrative reasons prior to completion

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: 111 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01040208
Sponsor's protocol ID: 511.114
Status last verified: Jul 2016
First submitted: 28 Dec 2009
Last updated: 24 Aug 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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety of Flibanserin Versus Placebo in Women Taking a Selective Serotonin Reuptake Inhibitor or Norepinephrine Serotonin Reuptake Inhibitor With Decreased Sexual Desire
ClinicalTrials.gov ID: NCT01040208
Acronym / sponsor ID: 511.114
Conditions: Sexual Dysfunctions, Psychological, Depression
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study terminated by Sponsor for administrative reasons prior to completion
Enrolment: 111 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: 29 Dec 2009 (estimated)
Results: Posted 24 Aug 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: 3

Arm	Type	Receives
flibanserin 50 mg to 100 mg qhs	Experimental	Drug: flibanserin 50 mg to 100 mg qhsPatient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs
flibanserin 100 mg qhs	Experimental	Drug: flibanserin 100 mg qhsPatient to receive 2 flibanserin tablets of 50 mg qhs
placebo 2 tablets qhs	Experimental	Drug: placebo 2 tablets qhsPatient to receive 2 placebo tablets of 50 mg qhs

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Women 18-50 years of age, not postmenopausal at the Screen Visit
Women with mild/remitted depressive disorder with score of <11 on the Quick Inventory of Depressive Symptoms Self Report and <16 on the Beck Anxiety Inventory at Screen/Baseline Visits
Women with decreased sexual desire and distress present at least 4 weeks at Screen Visit as determined by the Clinical Interview for Female Sexual Dysfunction-Depression and Diagnostic and Statistical Manual IV-Text Revision (DSM IV-TR)
Score of 15 or higher on the Female Sexual Distress Scale-Revised at Screen/Baseline Visits
Score of 9 or lower on the Changes in Sexual Functioning Questionnaire-Female desire/interest item at Screen/Baseline Visits

Key exclusion criteria (15 listed)

Conditions which may interfere with the ability to participate include, but are not limited to:
Patients who have taken any Prohibited Medications within 30 days before Baseline Visit
Patients with history of drug dependence/abuse (including alcohol) within past year
Patients with history of participation in a trial of another investigational drug within 1 month prior to the Screen Visit, or participation in previous flibanserin study
Women with lifelong decreased sexual desire (or Hypoactive Sexual Desire Disorder), Female Sexual Arousal Disorder and/or Female Orgasmic Disorder, per DSM IV-TR criteria

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
flibanserin 50 mg to 100 mg qhs50 to 100mg qhs	Drug	flibanserin 50 mg to 100 mg qhs
flibanserin 100 mg qhs100mg qhs	Drug	flibanserin 100 mg qhs
placebo 2 tablets qhs50 mg placebo	Drug	placebo 2 tablets qhs

Primary outcome

The Primary Safety Endpoint is the Occurrence of Adverse Events During the Treatment and Post Treatment Period.
Time frame: 17 weeks

2 secondary outcomes

The Occurrence of Mild Depressive Symptoms (i.e., a Total Score of '7' to '11', Inclusive) That Have Remitted (i.e., a Total Score of '6' or Less) on the 16 Item Quick Inventory of Depressive Symptoms - Self Report at Visit 6 (Week 12)
Time frame: 12 weeks
The Occurrence of Mild Anxiety Symptoms (i.e., a Total Score of '8' to '16', Inclusive) That Have Remitted (i.e., a Total Score of '7' or Less) on the Beck Anxiety Inventory at Visit 6 (Week 12)
Time frame: 12 weeks

Results and safety

Results posted to the registry on 24 Aug 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 50 mg to 100 mg Qhs (Take Daily, at Bedtime)	45	39
Flibanserin 100 mg Qhs	28	15
Placebo 2 Tablets Qhs	38	35

Primary outcome: The Primary Safety Endpoint is the Occurrence of Adverse Events During the Treatment and Post Treatment Period.

Time frame: 17 weeks. Number. Unit: participants

Measure	Flibanserin 50 mg to 100 mg Qhs n = 45	Flibanserin 100 mg Qhs n = 28	Placebo 2 Tablets Qhs n = 38
Value	16	14	32

Population analysed: The treated set (TS) consisted of those patients who were dispensed study medication and who were documented to have taken at least one dose of study medication. All analyses were conducted on the TS.

2 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
Flibanserin 50 mg to 100 mg Qhs	0 of 45 (0%)	16 of 45 (35.6%)	Not reported
Flibanserin 100 mg Qhs	0 of 28 (0%)	14 of 28 (50%)	Not reported
Placebo 2 Tablets Qhs	0 of 38 (0%)	32 of 38 (84.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 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

42 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 15 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 24 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 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. 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 24 Aug 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?

The Primary Safety Endpoint is the Occurrence of Adverse Events During the Treatment and Post Treatment Period. (time frame: 17 weeks). 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 NCT01040208.

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 24 Aug 2016.