Sexual Dysfunctions, PsychologicalPhase 3NCT00601367

Flibanserin Evaluation Over 28 Additional Weeks in Hypoactive Sexual Desire Disorder

A Phase 3 study testing flibanserin flexible dose in people with Sexual Dysfunctions, Psychological, run by Sprout Pharmaceuticals, Inc at 68 sites in 12 countries.

Completed

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

Official record

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Trial summary

Safety profile of flibanserin over 28 additional weeks Distribution of preferred dose regimens 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 flexible dose
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 480 participants
Where: 68 sitesin 12 countries
Study dates: Jan 2008to Oct 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 with a primary diagnosis of HSDD who still needs to be treated according to the investigator's opinion and willing to continue in this study. This continuation requires adequate compliance, in the Investigators judgement, with trial medication and the trial visit required in the parent clinical trial (Visit 1 to visit 9).
Patients must have used a medically acceptable method of contraception [i.e., double barrier method (e.g., diaphragm or condom and spermicide), hormonal therapy (subcutaneous, injectable, intra-vaginal, or oral contraceptive), intrauterine device, tubal sterilization, or partner's surgical sterilization] for at least 3 months before the Screen Visit and continue to use that medically acceptable method of contraception during the trial.

Who cannot join

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, or patient with any non-zero statement in the first five items for the Beck Scale for Suicide Ideation.
Patients must have a clinically acceptable Pap smear as read by a cytology facility (no evidence of malignancy or squamous intraepithelial lesions) within 6 months before the Inclusion Visit.
Patients with findings at the Screen Visit of pelvic inflammatory disease, urinary tract or vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy.
Patients experiencing major life stress (including parenting pressure, eldercare, loss of income, death of a family member, etc.) or relationship discord that could interfere with sexual activity, except distress about HSDD.
Clinically significant ECG abnormalities at the Screen Visit, according to the investigators opinion or the cardiologist who have performed the ECG. The following ECG values are considered to be exclusionary: QTc intervals >480 milliseconds (ms), PR intervals >240 ms, and QRS intervals >110 ms.

Trial locations and contacts

68 sites in 12 countries.

Country

City, postcode or hospital

68 sites in 12 countries

France11 sites

511.118.3308A Boehringer Ingelheim Investigational Site
Blanquefort
511.118.3301A Boehringer Ingelheim Investigational Site
Bordeaux
511.118.3305A Boehringer Ingelheim Investigational Site
La Rochelle
511.118.3314A Boehringer Ingelheim Investigational Site
Lille
511.118.3314B Cabinet médical
Lille
511.118.3303A Boehringer Ingelheim Investigational Site
Marseille
511.118.3310A Boehringer Ingelheim Investigational Site
Marseille
511.118.3312A Boehringer Ingelheim Investigational Site
Marseille
511.118.3315A Cabinet Médical
Rennes
511.118.3306A Boehringer Ingelheim Investigational Site
Saint-Émilion
511.118.3311A Boehringer Ingelheim Investigational Site
Toulouse

Other trials in France

United Kingdom8 sites

511.118.44009 Boehringer Ingelheim Investigational Site
Chorley
511.118.44004 Boehringer Ingelheim Investigational Site
Fisherwick, Lichfield
511.118.44008 Boehringer Ingelheim Investigational Site
Glasgow
511.118.44003 Boehringer Ingelheim Investigational Site
Headington, Oxford
511.118.44001 Boehringer Ingelheim Investigational Site
London
511.118.44002 Boehringer Ingelheim Investigational Site
London
511.118.44007 Boehringer Ingelheim Investigational Site
South Brent
511.118.44010 Boehringer Ingelheim Investigational Site
Waterloo, Liverpool

Other trials in United Kingdom

Germany7 sites

511.118.49004 Boehringer Ingelheim Investigational Site
Berlin
511.118.49001 Boehringer Ingelheim Investigational Site
Bonn
511.118.49006 Boehringer Ingelheim Investigational Site
Dresden
511.118.49008 Boehringer Ingelheim Investigational Site
Frankfurt
511.118.49003 Boehringer Ingelheim Investigational Site
Freiburg im Breisgau
511.118.49002 Boehringer Ingelheim Investigational Site
Hanover
511.118.49005 Boehringer Ingelheim Investigational Site
Leipzig

Other trials in Germany

Netherlands7 sites

511.118.31006 Boehringer Ingelheim Investigational Site
Almere Stad
511.118.31001 Boehringer Ingelheim Investigational Site
Amsterdam
511.118.31004 Boehringer Ingelheim Investigational Site
Apeldoorn
511.118.31003 Boehringer Ingelheim Investigational Site
Bilthoven
511.118.31007 Boehringer Ingelheim Investigational Site
Den Helder
511.118.31005 Boehringer Ingelheim Investigational Site
Enschede
511.118.31002 Boehringer Ingelheim Investigational Site
Nieuwegein

Other trials in Netherlands

Sweden6 sites

511.118.46004 Boehringer Ingelheim Investigational Site
Kungsbacka
511.118.46009 Boehringer Ingelheim Investigational Site
Lund
511.118.46001 Boehringer Ingelheim Investigational Site
Stockholm
511.118.46006 Boehringer Ingelheim Investigational Site
Stockholm
511.118.46005 Boehringer Ingelheim Investigational Site
Uppsala
511.118.46003 Boehringer Ingelheim Investigational Site
Västerås

Other trials in Sweden

Belgium5 sites

511.118.32004 Boehringer Ingelheim Investigational Site
Braine-l'Alleud
511.118.32003 Boehringer Ingelheim Investigational Site
Edegem
511.118.32005 Boehringer Ingelheim Investigational Site
Ghent
511.118.32006 Boehringer Ingelheim Investigational Site
Hasselt
511.118.32002 Boehringer Ingelheim Investigational Site
Yvoir

Other trials in Belgium

Finland5 sites

511.118.35801 Boehringer Ingelheim Investigational Site
Espoo
511.118.35805 Boehringer Ingelheim Investigational Site
Helsinki
511.118.35802 Boehringer Ingelheim Investigational Site
Oulu
511.118.35803 Boehringer Ingelheim Investigational Site
Seinäjoki
511.118.35804 Boehringer Ingelheim Investigational Site
Tampere

Other trials in Finland

Austria4 sites

511.118.43005 Boehringer Ingelheim Investigational Site
Innsbruck
511.118.43002 Boehringer Ingelheim Investigational Site
Vienna
511.118.43004 Boehringer Ingelheim Investigational Site
Vienna
511.118.43006 Boehringer Ingelheim Investigational Site
Wörgl

Other trials in Austria

Czechia4 sites

511.118.42001 Boehringer Ingelheim Investigational Site
Olomouc
511.118.42002 Boehringer Ingelheim Investigational Site
Prague
511.118.42003 Boehringer Ingelheim Investigational Site
Prague
511.118.42004 Boehringer Ingelheim Investigational Site
Vřesina

Other trials in Czechia

Hungary4 sites

511.118.36001 Boehringer Ingelheim Investigational Site
Budapest
511.118.36005 Boehringer Ingelheim Investigational Site
Kecskemét
511.118.36003 Boehringer Ingelheim Investigational Site
Szeged
511.118.36004 Boehringer Ingelheim Investigational Site
Szentes

Other trials in Hungary

Spain4 sites

511.118.34004 Boehringer Ingelheim Investigational Site
Barcelona
511.118.34003 Boehringer Ingelheim Investigational Site
Manresa (Barcelona)
511.118.34002 Boehringer Ingelheim Investigational Site
Mataró-Barcelona
511.118.34001 Boehringer Ingelheim Investigational Site
Ourense

Other trials in Spain

Italy3 sites

511.118.39004 Boehringer Ingelheim Investigational Site
Catania
511.118.39001 Boehringer Ingelheim Investigational Site
Pavia
511.118.39003 Boehringer Ingelheim Investigational Site
Torino

Other trials in Italy

About this study

Official title: A Twenty-Eight Week, Open-Label, Safety Study of Flibanserin 50 Mgs to 100 Mgs Daily in Premenopausal European Women With HSDD

Safety profile of flibanserin over 28 additional weeks Distribution of preferred dose regimens

Conditions: Sexual Dysfunctions, Psychological
Being tested: flibanserin flexible dose
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.

flibanserin flexible doseDrug
Initial dosage:
Patients were to take one 50 mg flibanserin tablet in the evening.
Subsequent dosage titrations:
Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient.
Flibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY.
Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site.

Study groups in NCT00601367
Study group	Role	What they receive
flibanserin flexible dose	Experimental	Initial dosage: Patients were to take one 50 mg flibanserin tablet in the evening. Subsequent dosage titrations: Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site. Receives: Drug: flibanserin flexible dose

What is being measured

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

Frequency of Adverse Events
Measured: 28 weeks

Timeline

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

Jan 2008Oct 2009

First posted28 Jan 2008 (estimated)
Study startJan 2008
Primary completionOct 2009
Study completionOct 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 480 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00601367
Sponsor's protocol ID: 511.118
Status last verified: May 2014
First submitted: 15 Jan 2008
Last updated: 20 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?

See locations

RecruitingObservational study
The PANHIS Study: Sexual Health in Spanish-Speaking Adults - A Cross-Sectional Online Survey
Sexual Health, Sexual Dysfunction, Physiological
Not yet recruitingPhase 1/2
BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder
Early-stage Breast Cancer, Hypoactive Sexual Desire Disorder
Active, not recruitingPhase 4
Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease
Peyronie Disease, Sexual Dysfunctions, Psychological
Active, not recruiting
Early Psychological Intervention After Rape
Post Traumatic Stress Disorder, Rape Sexual Assault
Active, not recruiting
Sexual Health and Rehabilitation Online (SHAREonline)
Cancer Survivorship, Sexual Function Disturbances

All Sexual Dysfunctions, Psychological trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Twenty-Eight Week, Open-Label, Safety Study of Flibanserin 50 Mgs to 100 Mgs Daily in Premenopausal European Women With HSDD
ClinicalTrials.gov ID: NCT00601367
Acronym / sponsor ID: 511.118
Conditions: Sexual Dysfunctions, Psychological
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 480 participants (actual)
Lead sponsor: Sprout Pharmaceuticals, IncIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Oct 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 28 Jan 2008 (estimated)
Results: Posted 20 Jun 2014

Clinical summary

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

Safety profile of flibanserin over 28 additional weeks Distribution of preferred dose regimens

Study design

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

Arm	Type	Receives
flibanserin flexible dose	Experimental	Drug: flibanserin flexible doseInitial dosage: Patients were to take one 50 mg flibanserin tablet in the evening. Subsequent dosage titrations: Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site.

Who may qualify

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

Key inclusion criteria (2 listed)

Women with a primary diagnosis of HSDD who still needs to be treated according to the investigator's opinion and willing to continue in this study. This continuation requires adequate compliance, in the Investigators judgement, with trial medication and the trial visit required in the parent clinical trial (Visit 1 to visit 9).
Patients must have used a medically acceptable method of contraception [i.e., double barrier method (e.g., diaphragm or condom and spermicide), hormonal therapy (subcutaneous, injectable, intra-vaginal, or oral contraceptive), intrauterine device, tubal sterilization, or partner's surgical sterilization] for at least 3 months before the Screen Visit and continue to use that medically acceptable method of contraception during the trial.

Key exclusion criteria (5 listed)

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, or patient with any non-zero statement in the first five items for the Beck Scale for Suicide Ideation.
Patients must have a clinically acceptable Pap smear as read by a cytology facility (no evidence of malignancy or squamous intraepithelial lesions) within 6 months before the Inclusion Visit.
Patients with findings at the Screen Visit of pelvic inflammatory disease, urinary tract or vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy.
Patients experiencing major life stress (including parenting pressure, eldercare, loss of income, death of a family member, etc.) or relationship discord that could interfere with sexual activity, except distress about HSDD.
Clinically significant ECG abnormalities at the Screen Visit, according to the investigators opinion or the cardiologist who have performed the ECG. The following ECG values are considered to be exclusionary: QTc intervals >480 milliseconds (ms), PR intervals >240 ms, and QRS intervals >110 ms.

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 flexible doseInitial dosage: Patients were to take one 50 mg flibanserin tablet in the evening. Subsequent dosage titrations: Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site.	Drug	flibanserin flexible dose

Primary outcome

Frequency of Adverse Events
Time frame: 28 weeks

Results and safety

Results posted to the registry on 20 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 Flexible Dose	480	293

Primary outcome: Frequency of Adverse Events

Time frame: 28 weeks. Number. Unit: participants with any adverse event

Measure	Flibanserin Flexible Dose n = 480
patients with any adverse event	331
patients with drug-related adverse events	206
patients with adverse events leading to discontinu	58
patients with severe adverse events	51
patients with serious adverse events	9

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Flibanserin Flexible Dose	9 of 480 (1.9%)	275 of 480 (57.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Sexual Dysfunctions, Psychological

RecruitingObservational study
The PANHIS Study: Sexual Health in Spanish-Speaking Adults - A Cross-Sectional Online Survey
Sexual Health, Sexual Dysfunction, Physiological
Not yet recruitingPhase 1/2
BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder
Early-stage Breast Cancer, Hypoactive Sexual Desire Disorder
Active, not recruitingPhase 4
Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease
Peyronie Disease, Sexual Dysfunctions, Psychological
Active, not recruiting
Early Psychological Intervention After Rape
Post Traumatic Stress Disorder, Rape Sexual Assault
Active, not recruiting
Sexual Health and Rehabilitation Online (SHAREonline)
Cancer Survivorship, Sexual Function Disturbances

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

68 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing flibanserin flexible dose in people with Sexual Dysfunctions, Psychological, run by Sprout Pharmaceuticals, Inc at 68 sites in 12 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 2 inclusion and 5 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 20 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 68 sites in France, United Kingdom, Germany, Netherlands, Sweden and 7 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. 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 20 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?

Frequency of Adverse Events (time frame: 28 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 NCT00601367.

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 20 Jun 2014; AzTrials last refreshed its copy on 1 Nov 2026.