- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01188603
Pharmacokinetics of Flibanserin in Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD)
May 15, 2014 updated by: Sprout Pharmaceuticals, Inc
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Orlando, Florida, United States
- 511.146.01003 Boehringer Ingelheim Investigational Site
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Kansas
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Wichita, Kansas, United States
- 511.146.01005 Boehringer Ingelheim Investigational Site
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Michigan
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Kalamazoo, Michigan, United States
- 511.146.01001 Boehringer Ingelheim Investigational Site
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Tennessee
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Knoxville, Tennessee, United States
- 511.146.01004 Boehringer Ingelheim Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: flibanserin
flibanserin 100 mg dose every evening
|
all subjects receive flibanserin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Flibanserin: Area Under the Curve; AUC_0-∞
Time Frame: 8 days
|
Geometric mean of the AUC_0-∞ of Flibanserin
|
8 days
|
Flibanserin: AUC τ,ss
Time Frame: 8 days
|
Geometric mean of the AUC τ,ss of Flibanserin
|
8 days
|
Flibanserin: Cmax (Peak Concentration)
Time Frame: 8 days
|
Geometric mean of the Cmax of Flibanserin
|
8 days
|
Flibanserin: Cmax,ss
Time Frame: 8 days
|
Geometric mean of the Cmax,ss of Flibanserin
|
8 days
|
Flibanserin: Tmax,ss
Time Frame: 8 days
|
Median of the tmax,ss of Flibanserin
|
8 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (ACTUAL)
October 1, 2010
Study Completion (ACTUAL)
October 1, 2010
Study Registration Dates
First Submitted
August 24, 2010
First Submitted That Met QC Criteria
August 24, 2010
First Posted (ESTIMATE)
August 25, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
May 21, 2014
Last Update Submitted That Met QC Criteria
May 15, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 511.146
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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