Sexual Dysfunctions, PsychologicalPhase 3NCT00491829

Flibanserin Versus Placebo in Premenopausal Women With HSDD

A Phase 3 study testing 50 mg qhs and 100 mg in people with Sexual Dysfunctions, Psychological, run by Sprout Pharmaceuticals, Inc at 86 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To establish efficacy of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in 6-month treatment, vs placebo for Hypoactive Sexual Desire Disorder in premenopausal European women. To evaluate safety and tolerability of flibanserin in such patients. 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?: 50 mg qhs and 100 mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 945 participants
Where: 86 sitesin 13 countries
Study dates: Jun 2007to Mar 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Women who are 18 years of age and older at the Screen Visit.
Premenopausal women per the Stages of Reproductive Aging Workshop (STRAW) criteria with the primary diagnosis of HSDD, generalized acquired type, according to DSM IV-TR criteria. The current episode must be at least 24 weeks in duration by the Baseline Visit. Secondary Female Sexual Arousal Disorder and/or Female Orgasmic Disorder are allowed. This inclusion criterion is met only if the HSDD commenced prior to Female Sexual Arousal Disorder and/or Female Orgasmic Disorder and the HSDD is of more importance to the patient, in the investigator judgement
A score of 15 or higher on the Female Sexual Distress Scale-Revised (FSDS-R)© (R04-1068) at the Screen Visit.
Item Number Two of the Sexual Interest and Desire Inventory - Female© (SIDI-F©) must be rated as "0" or "1" at the Screen Visit
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 eDiary on a daily basis (e.g., have access to a working land line or wireless telephone for daily data transmissions).
At the Baseline Visit, patients must have complied with eDiary use adequately, having missing entries for five or less days during the 28-day Screen period.
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 relationship is to be with the same partner who is sexually functional, both psychologically and physically, and the partner is expected to be physically present (i.e., available for sexual activity at some time during a 24 hour day) at least 50% of each month during the 4-week Screen period and 24-week efficacy period of the trial.

Who cannot join

Patients who have taken any medication noted in Appendix 10.6.1, Part I - List of prohibited medications, within 30 days before the Screen Visit; the same medications are prohibited throughout participation in the study.
Patients whose sexual function was affected (enhanced or worsened) in the investigator opinion by any medication within 30 days before the Screen Visit and anytime prior to the Baseline Visit. This must be determined by the investigator judgement after performing a detailed review of the patient sexual history and concomitant therapy.
Patients with a history of drug dependence or abuse (including alcohol, as defined in DSM IV-TR or in the opinion of the investigator) within the past 1 year
Patients who meet DSM IV-TR criteria for Sexual Aversion Disorder, Substance-Induced Sexual Dysfunction, Dyspareunia (not caused by inadequate foreplay stimulation or alleviated by lubricants), Vaginismus, Gender Identity Disorder, Paraphilia, or for Sexual Dysfunction Due to a General Medical Condition.
Patients who indicate that their sexual partner has organic or psychosexual dysfunction that could interfere with a patient response to treatment.
Patients who have entered the peri-menopause stage (menopausal transition) or the post menopause stage [i.e., have had hysterectomy (without bilateral oophorectomy), bilateral oophorectomy, endometrial ablation (any type), and chemical induced (e.g., chemotherapy)] according to the STRAW criteria.
Patients with a history of MDD within 6 months prior the Screen Visit or a score of 14 on the Beck Depression Inventory© II, or a history of suicide attempt according to the Beck Scale for Suicide Ideation.

Trial locations and contacts

86 sites in 13 countries.

Country

City, postcode or hospital

86 sites in 13 countries

France13 sites

511.77.3308A Boehringer Ingelheim Investigational Site
Blanquefort
511.77.3301A Boehringer Ingelheim Investigational Site
Bordeaux
511.77.3305A Boehringer Ingelheim Investigational Site
La Rochelle
511.77.3314A Boehringer Ingelheim Investigational Site
Lille
511.77.3314B Cabinet médical
Lille
511.77.3314C Cabinet médical
Lille
511.77.3303A Boehringer Ingelheim Investigational Site
Marseille
511.77.3310A Boehringer Ingelheim Investigational Site
Marseille
511.77.3312A Boehringer Ingelheim Investigational Site
Marseille
511.77.3302A Boehringer Ingelheim Investigational Site
Paris
511.77.3315A Cabinet Médical
Rennes
511.77.3306A Boehringer Ingelheim Investigational Site
Saint-Émilion
511.77.3311A Boehringer Ingelheim Investigational Site
Toulouse

Other trials in France

United Kingdom10 sites

511.77.44011 Boehringer Ingelheim Investigational Site
Belfast
511.77.44009 Boehringer Ingelheim Investigational Site
Chorley
511.77.44004 Boehringer Ingelheim Investigational Site
Fisherwick, Lichfield
511.77.44008 Boehringer Ingelheim Investigational Site
Glasgow
511.77.44003 Boehringer Ingelheim Investigational Site
Headington, Oxford
511.77.44005 Boehringer Ingelheim Investigational Site
Leeds
511.77.44001 Boehringer Ingelheim Investigational Site
London
511.77.44002 Boehringer Ingelheim Investigational Site
London
511.77.44007 Boehringer Ingelheim Investigational Site
South Brent
511.77.44010 Boehringer Ingelheim Investigational Site
Waterloo, Liverpool

Other trials in United Kingdom

Germany9 sites

511.77.49004 Boehringer Ingelheim Investigational Site
Berlin
511.77.49007 Boehringer Ingelheim Investigational Site
Bochum
511.77.49001 Boehringer Ingelheim Investigational Site
Bonn
511.77.49006 Boehringer Ingelheim Investigational Site
Dresden
511.77.49008 Boehringer Ingelheim Investigational Site
Frankfurt
511.77.49003 Boehringer Ingelheim Investigational Site
Freiburg im Breisgau
511.77.49002 Boehringer Ingelheim Investigational Site
Hanover
511.77.49005 Boehringer Ingelheim Investigational Site
Leipzig
511.77.49009 Boehringer Ingelheim Investigational Site
Magdeburg

Other trials in Germany

Netherlands9 sites

511.77.31006 Boehringer Ingelheim Investigational Site
Almere Stad
511.77.31001 Boehringer Ingelheim Investigational Site
Amsterdam
511.77.31004 Boehringer Ingelheim Investigational Site
Apeldoorn
511.77.31007 Boehringer Ingelheim Investigational Site
Den Helder
511.77.31005 Boehringer Ingelheim Investigational Site
Enschede
511.77.31002 St Antonius ziekenhuis
Nieuwegein
511.77.31009 Boehringer Ingelheim Investigational Site
The Hague
511.77.31008 Boehringer Ingelheim Investigational Site
Tilburg
511.77.31003 Boehringer Ingelheim Investigational Site
Zeist

Other trials in Netherlands

Sweden8 sites

511.77.46004 Boehringer Ingelheim Investigational Site
Kungsbacka
511.77.46009 Boehringer Ingelheim Investigational Site
Lund
511.77.46007 Boehringer Ingelheim Investigational Site
Malmö
511.77.46001 Junoenheten/Kvinnohälsan, Kvinnokliniken
Stockholm
511.77.46002 Boehringer Ingelheim Investigational Site
Stockholm
511.77.46006 Boehringer Ingelheim Investigational Site
Stockholm
511.77.46005 Boehringer Ingelheim Investigational Site
Uppsala
511.77.46003 Boehringer Ingelheim Investigational Site
Västerås

Other trials in Sweden

Spain6 sites

511.77.34004 Boehringer Ingelheim Investigational Site
Barcelona
511.77.34005 Boehringer Ingelheim Investigational Site
Barcelona
511.77.34006 Boehringer Ingelheim Investigational Site
L´Hospitalet Del LLobregat
511.77.34003 Boehringer Ingelheim Investigational Site
Manresa (Barcelona)
511.77.34002 Boehringer Ingelheim Investigational Site
Mataró-Barcelona
511.77.34001 Boehringer Ingelheim Investigational Site
Ourense

Other trials in Spain

Austria5 sites

511.77.43005 Boehringer Ingelheim Investigational Site
Innsbruck
511.77.43001 Boehringer Ingelheim Investigational Site
Vienna
511.77.43002 Boehringer Ingelheim Investigational Site
Vienna
511.77.43004 Boehringer Ingelheim Investigational Site
Vienna
511.77.43006 Boehringer Ingelheim Investigational Site
Wörgl

Other trials in Austria

Belgium5 sites

511.77.32004 Boehringer Ingelheim Investigational Site
Braine-l'Alleud
511.77.32003 Boehringer Ingelheim Investigational Site
Edegem
511.77.32005 Boehringer Ingelheim Investigational Site
Ghent
511.77.32006 Boehringer Ingelheim Investigational Site
Hasselt
511.77.32002 Boehringer Ingelheim Investigational Site
Yvoir

Other trials in Belgium

Finland5 sites

511.77.35801 Boehringer Ingelheim Investigational Site
Espoo
511.77.35805 Boehringer Ingelheim Investigational Site
Helsinki
511.77.35802 Boehringer Ingelheim Investigational Site
Oulu
511.77.35803 Boehringer Ingelheim Investigational Site
Seinäjoki
511.77.35804 Boehringer Ingelheim Investigational Site
Tampere

Other trials in Finland

Czechia4 sites

511.77.42001 Boehringer Ingelheim Investigational Site
Olomouc
511.77.42002 Boehringer Ingelheim Investigational Site
Prague
511.77.42003 Boehringer Ingelheim Investigational Site
Prague
511.77.42004 Boehringer Ingelheim Investigational Site
Vřesina

Other trials in Czechia

Hungary4 sites

511.77.36001 Boehringer Ingelheim Investigational Site
Budapest
511.77.36005 Boehringer Ingelheim Investigational Site
Kecskemét
511.77.36003 Boehringer Ingelheim Investigational Site
Szeged
511.77.36004 Boehringer Ingelheim Investigational Site
Szentes

Other trials in Hungary

Italy4 sites

511.77.39004 Ospedale S. Bambino
Catania
511.77.39001 IRCCS S. Fondazione Maugeri
Pavia
511.77.39002 Ospedale Santa Chiara
Pisa
511.77.39003 Ospedale Sant'Anna
Torino

Other trials in Italy

Norway4 sites

511.77.47002 Boehringer Ingelheim Investigational Site
Lillestrøm
511.77.47001 Boehringer Ingelheim Investigational Site
Oslo
511.77.47003 Boehringer Ingelheim Investigational Site
Oslo
511.77.47004 Boehringer Ingelheim Investigational Site
Oslo

Other trials in Norway

About this study

Official title: A Twenty-Four Week, Randomized, Double-Blind, Placebo Controlled, Safety and Efficacy Trial of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in Premenopausal European Women With Hypoactive Sexual Desire Disorder

To establish efficacy of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in 6-month treatment, vs placebo for Hypoactive Sexual Desire Disorder in premenopausal European women.

To evaluate safety and tolerability of flibanserin in such patients.

Conditions: Sexual Dysfunctions, Psychological
Being tested: 50 mg qhs, 100 mg, 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.

50 mg qhsDrug
flibanserin 50 mg
100 mgDrug
flibanserin 100mg
placeboDrug
placebo

Study groups in NCT00491829
Study group	Role	What they receive
flibanserin	Experimental	50 mg qhs Receives: Drug: 50 mg qhs
flibanserin 100mg	Experimental	100 mg qhs Receives: Drug: 100 mg
placebo	Placebo comparator	placebo qhs 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 Frequency of Satisfying Sexual Events as Measured by the eDiary.
To obtain information on satisfying sexual events (SSEs), a small personal handheld electronic device was to be used by the patients to record such information daily (eDiary). An SSE was recorded when a patient answered "yes" to the eDiary question: "Was the event satisfying for you?"
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.

Jun 2007Mar 2009

First posted26 Jun 2007 (estimated)
Study startJun 2007
Primary completionMar 2009
Study completionMar 2009

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: 945 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00491829
Sponsor's protocol ID: 511.77
Status last verified: May 2014
First submitted: 25 Jun 2007
Last updated: 2 Jun 2014
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 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Twenty-Four Week, Randomized, Double-Blind, Placebo Controlled, Safety and Efficacy Trial of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in Premenopausal European Women With Hypoactive Sexual Desire Disorder
ClinicalTrials.gov ID: NCT00491829
Acronym / sponsor ID: 511.77
Conditions: Sexual Dysfunctions, Psychological
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 945 participants (actual)
Lead sponsor: Sprout Pharmaceuticals, IncIndustry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: Mar 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 26 Jun 2007 (estimated)
Results: Posted 2 Jun 2014

Clinical summary

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

To establish efficacy of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in 6-month treatment, vs placebo for Hypoactive Sexual Desire Disorder in premenopausal European women.

To evaluate safety and tolerability of flibanserin in such patients.

Study design

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

Arm	Type	Receives
flibanserin	Experimental	Drug: 50 mg qhs50 mg qhs
flibanserin 100mg	Experimental	Drug: 100 mg100 mg qhs
placebo	Placebo comparator	Drug: placeboplacebo qhs

Who may qualify

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

Key inclusion criteria (8 listed)

Women who are 18 years of age and older at the Screen Visit.
Premenopausal women per the Stages of Reproductive Aging Workshop (STRAW) criteria with the primary diagnosis of HSDD, generalized acquired type, according to DSM IV-TR criteria. The current episode must be at least 24 weeks in duration by the Baseline Visit. Secondary Female Sexual Arousal Disorder and/or Female Orgasmic Disorder are allowed. This inclusion criterion is met only if the HSDD commenced prior to Female Sexual Arousal Disorder and/or Female Orgasmic Disorder and the HSDD is of more importance to the patient, in the investigator judgement
A score of 15 or higher on the Female Sexual Distress Scale-Revised (FSDS-R)© (R04-1068) at the Screen Visit.
Item Number Two of the Sexual Interest and Desire Inventory - Female© (SIDI-F©) must be rated as "0" or "1" at the Screen Visit
Patients must be willing to try to have sexual activity (e.g., any act involving direct genital stimulation) at least once monthly.

Key exclusion criteria (7 listed)

Patients who have taken any medication noted in Appendix 10.6.1, Part I - List of prohibited medications, within 30 days before the Screen Visit; the same medications are prohibited throughout participation in the study.
Patients whose sexual function was affected (enhanced or worsened) in the investigator opinion by any medication within 30 days before the Screen Visit and anytime prior to the Baseline Visit. This must be determined by the investigator judgement after performing a detailed review of the patient sexual history and concomitant therapy.
Patients with a history of drug dependence or abuse (including alcohol, as defined in DSM IV-TR or in the opinion of the investigator) within the past 1 year
Patients who meet DSM IV-TR criteria for Sexual Aversion Disorder, Substance-Induced Sexual Dysfunction, Dyspareunia (not caused by inadequate foreplay stimulation or alleviated by lubricants), Vaginismus, Gender Identity Disorder, Paraphilia, or for Sexual Dysfunction Due to a General Medical Condition.
Patients who indicate that their sexual partner has organic or psychosexual dysfunction that could interfere with a patient response to treatment.

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
50 mg qhsflibanserin 50 mg	Drug	flibanserin
100 mgflibanserin 100mg	Drug	flibanserin 100mg
placeboplacebo	Drug	placebo

Primary outcome

Change From Baseline in the Frequency of Satisfying Sexual Events as Measured by the eDiary.
Time frame: baseline to 24 weeks
To obtain information on satisfying sexual events (SSEs), a small personal handheld electronic device was to be used by the patients to record such information daily (eDiary). An SSE was recorded when a patient answered "yes" to the eDiary question: "Was the event satisfying for you?"

Results and safety

Results posted to the registry on 2 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 50mg	311	216
Flibanserin 100mg	316	202
Placebo	318	243

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

Time frame: baseline to 24 weeks. Mean (Standard Deviation). Unit: events per month

Measure	Flibanserin 50mg n = 297	Flibanserin 100mg n = 299	Placebo n = 307
Value	1.2 (3.7)	1.5 (4.0)	0.9 (3.2)

Population analysed: Patients who had at least one post-dose on-treatment efficacy assessment were included in the Full Analysis Set (FAS). The FAS was used for primary analyses.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Flibanserin 50mg	25 of 311 (8%)	174 of 311 (55.9%)	Not reported
Flibanserin 100mg	19 of 316 (6%)	238 of 316 (75.3%)	Not reported
Placebo	16 of 318 (5%)	143 of 318 (45%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2014.
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

86 sites in 13 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 50 mg qhs and 100 mg in people with Sexual Dysfunctions, Psychological, run by Sprout Pharmaceuticals, Inc at 86 sites in 13 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 8 inclusion and 7 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 2 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 86 sites in France, United Kingdom, Germany, Netherlands, Sweden and 8 more countries. 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 2 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 Frequency of Satisfying Sexual Events as Measured by the eDiary. (time frame: baseline to 24 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 NCT00491829.

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 2 Jun 2014.