Sexual Dysfunctions, PsychologicalPhase 1NCT01188603

Pharmacokinetics of Flibanserin in Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD)

A Phase 1 study testing flibanserin 100 mg dose every evening in people with Sexual Dysfunctions, Psychological, run by Sprout Pharmaceuticals, Inc at 4 sites in United States.

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

This trial examines the way flibanserin is metabolized in postmenopausal women with Hypoactive Sexual Desire Disorder. Read more about this study

Who is it for?: Any age, women only
Conditions the study is for: Sexual Dysfunctions, Psychological
What is being tested?: flibanserin 100 mg dose every evening
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 4 sitesUnited States
Study dates: Jul 2010to Oct 2010
Phase: Phase 1
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 Any age
Women only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patients must be in a stable, monogamous heterosexual relationship for at least one year.
Patients must have a primary diagnosis of Hypoactive Sexual Desire Disorder for at least six months.
Patients must be naturally postmenopausal women of any age with at least one ovary.
Patients may participate whether or not they are currently taking systemic hormone therapy provided the therapy was not prescribed for treatment of low sexual desire. Hormone therapy must be at a stable dose for at least six months.

Who cannot join

Patients with a history of drug dependence or abuse within the past twelve months.
Patients who have been previously treated with flibanserin.
Patients who have sexual dysfunctions other than Hypoactive Sexual Desire Disorder, such as: Sexual Aversion Disorder, Substance-Induced Sexual Dysfunction, Dyspareunia, Vaginismus, Gender Identity Disorder,Paraphilia, or Sexual Dysfunction due to a general medical condition.
Patients who indicate that their sexual partner has inadequately treated organic or psychosexual dysfunction that could interfere with a patients response to treatment.
Patients whose sexual function was impaired, in the investigators opinion, by abdominal or vaginal hysterectomy, oophorectomy or any other pelvic, vaginal, or urologic surgery.
Patients with pelvic pain, pelvic inflammatory disease, endometriosis, urinary tract or vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, symptomatic vaginal atrophy or any other gynecological pathology requiring further evaluation.

Show all 20Show fewer

Patients with a history of unexplained vaginal bleeding within the past twelve months.
Patients with a history of Major Depressive Disorder within six months prior to Screening; ; active suicidal ideation with intent in the past ten years or suicidal behavior at any time.
Patients with a history of any other psychiatric disorder that could impact sexual function, increase risks to patient safety, or impair patient compliance. Such disorders include but are not limited to bipolar disorder, psychotic disorders, severe anxiety, eating disorders, and antisocial personality disorders.
Clinically significant electrocardiogram abnormalities at Screening.
Patients with a history of dementia or other neurodegenerative disease; organic brain disease; stroke; transient ischemic attacks; multiple sclerosis; spinal cord injury; brain surgery; significant brain trauma; peripheral neuropathy; and epilepsy.
Patients with ongoing hepatic impairment (cirrhosis, hepatic tumor, or other hepatic disease); peptic ulcer within six months prior to Screening; elevated liver enzymes ; inflammatory bowel disease; gastrointestinal bleeding within two months prior to Screening; Patients who have had bariatric surgery for obesity.
Patients with a history of angina; atherosclerotic cardiovascular disease; congestive heart failure; cardiomyopathy; symptomatic cardiac valve disease; arrhythmia; hypertension.
Patients with a history of renal failure; known history of chronic glomerulonephritis.
Patients with a history of chronic obstructive pulmonary disease, chronic bronchitis, or asthma not well controlled with medication taken twice daily or less.
Patients with a history of gonadotrophic hormone disorders or uncontrolled diabetes mellitus.
Uncorrected hypothyroidism or hyperthyroidism.
Patients with a history of uncontrolled glaucoma.
Patients with known Human Immunodeficiency Virus infection, Acquired Immunodeficiency Syndrome, other clinically significant immunological disorders or auto-immune disorders such as lupus or scleroderma.
Patients with a history of any cancer within the past ten years, other than non-invasive, previously resected basal cell carcinoma of the skin.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

511.146.01001 Boehringer Ingelheim Investigational Site
Kalamazoo, Michigan
511.146.01004 Boehringer Ingelheim Investigational Site
Knoxville, Tennessee
511.146.01003 Boehringer Ingelheim Investigational Site
Orlando, Florida
511.146.01005 Boehringer Ingelheim Investigational Site
Wichita, Kansas

Other trials in United States

About this study

Official title: Evaluation of Single Dose and Steady State Pharmacokinetics of Flibanserin Postmenopausal Women With Hypoactive Sexual Desire Disorder

This trial examines the way flibanserin is metabolized in postmenopausal women with Hypoactive Sexual Desire Disorder.

Conditions: Sexual Dysfunctions, Psychological
Being tested: flibanserin 100 mg dose every evening
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 100 mg dose every eveningDrug
all subjects receive flibanserin

Study groups in NCT01188603
Study group	Role	What they receive
flibanserin	Experimental	flibanserin 100 mg dose every evening Receives: Drug: flibanserin 100 mg dose every evening

What is being measured

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

Flibanserin: Area Under the Curve; AUC_0-∞
Geometric mean of the AUC_0-∞ of Flibanserin
Measured: 8 days
Flibanserin: AUC τ,ss
Geometric mean of the AUC τ,ss of Flibanserin
Measured: 8 days
Flibanserin: Cmax (Peak Concentration)
Geometric mean of the Cmax of Flibanserin
Measured: 8 days
Flibanserin: Cmax,ss
Geometric mean of the Cmax,ss of Flibanserin
Measured: 8 days
Flibanserin: Tmax,ss
Median of the tmax,ss of Flibanserin
Measured: 8 days

Timeline

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

Jul 2010Oct 2010

First posted25 Aug 2010 (estimated)
Study startJul 2010
Primary completionOct 2010
Study completionOct 2010

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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01188603
Sponsor's protocol ID: 511.146
Status last verified: May 2014
First submitted: 24 Aug 2010
Last updated: 21 May 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Official title: Evaluation of Single Dose and Steady State Pharmacokinetics of Flibanserin Postmenopausal Women With Hypoactive Sexual Desire Disorder
ClinicalTrials.gov ID: NCT01188603
Acronym / sponsor ID: 511.146
Conditions: Sexual Dysfunctions, Psychological
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Sprout Pharmaceuticals, IncIndustry (pharma, biotech, devices)
Study start: Jul 2010
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 25 Aug 2010 (estimated)
Results: Posted 10 Apr 2012

Clinical summary

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

This trial examines the way flibanserin is metabolized in postmenopausal women with Hypoactive Sexual Desire Disorder.

Study design

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

Arm	Type	Receives
flibanserin	Experimental	Drug: flibanserin 100 mg dose every eveningflibanserin 100 mg dose every evening

Who may qualify

Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Patients must be in a stable, monogamous heterosexual relationship for at least one year.
Patients must have a primary diagnosis of Hypoactive Sexual Desire Disorder for at least six months.
Patients must be naturally postmenopausal women of any age with at least one ovary.
Patients may participate whether or not they are currently taking systemic hormone therapy provided the therapy was not prescribed for treatment of low sexual desire. Hormone therapy must be at a stable dose for at least six months.

Key exclusion criteria (20 listed)

Patients with a history of drug dependence or abuse within the past twelve months.
Patients who have been previously treated with flibanserin.
Patients who have sexual dysfunctions other than Hypoactive Sexual Desire Disorder, such as: Sexual Aversion Disorder, Substance-Induced Sexual Dysfunction, Dyspareunia, Vaginismus, Gender Identity Disorder,Paraphilia, or Sexual Dysfunction due to a general medical condition.
Patients who indicate that their sexual partner has inadequately treated organic or psychosexual dysfunction that could interfere with a patients response to treatment.
Patients whose sexual function was impaired, in the investigators opinion, by abdominal or vaginal hysterectomy, oophorectomy or any other pelvic, vaginal, or urologic 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
flibanserin 100 mg dose every eveningall subjects receive flibanserin	Drug	flibanserin

Primary outcome

Flibanserin: Area Under the Curve; AUC_0-∞
Time frame: 8 days
Geometric mean of the AUC_0-∞ of Flibanserin
Flibanserin: AUC τ,ss
Time frame: 8 days
Geometric mean of the AUC τ,ss of Flibanserin
Flibanserin: Cmax (Peak Concentration)
Time frame: 8 days
Geometric mean of the Cmax of Flibanserin
Flibanserin: Cmax,ss
Time frame: 8 days
Geometric mean of the Cmax,ss of Flibanserin
Flibanserin: Tmax,ss
Time frame: 8 days
Median of the tmax,ss of Flibanserin

Results and safety

Results posted to the registry on 10 Apr 2012, 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	24	24

Primary outcome: Flibanserin: Area Under the Curve; AUC_0-∞

Time frame: 8 days. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Flibanserin n = 22
Value	2570 (73.0)

Primary outcome: Flibanserin: AUC τ,ss

Time frame: 8 days. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Flibanserin n = 24
Value	3000 (60.9)

Population analysed: All patients with values for the area under the concentration-time curve of the analyte in plasma over a dosing interval τ at steady state (AUC τ,ss)

Primary outcome: Flibanserin: Cmax (Peak Concentration)

Time frame: 8 days. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Flibanserin n = 22
Value	298 (56.4)

Population analysed: All patients with values for the maximum concentration of Flibanserin in plasma after single dose (Cmax)

Primary outcome: Flibanserin: Cmax,ss

Time frame: 8 days. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Flibanserin n = 24
Value	406 (60.7)

Population analysed: All patients with values for the maximum concentration of Flibanserin in plasma after single dose at steady state (Cmax,ss)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Flibanserin	0 of 24 (0%)	13 of 24 (54.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 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.

Sprout Pharmaceuticals study chair

Sprout Pharmaceuticals

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing flibanserin 100 mg dose every evening in people with Sexual Dysfunctions, Psychological, run by Sprout Pharmaceuticals, Inc at 4 sites in United States.

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 4 inclusion and 20 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 21 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 4 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 10 Apr 2012). 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?

Flibanserin: Area Under the Curve; AUC_0-∞ (time frame: 8 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01188603.

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 21 May 2014.