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 - ND
- Conditions
- Primary generalized acquired Hypoactive Sexual Desire Disorder in Premenopausal womenMedDRA version: 9.1Level: LLTClassification code 10020933Term: Hypoactive sexual desire disorder
- Registration Number
- EUCTR2007-000032-68-IT
- Lead Sponsor
- BOEHRINGER ING.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 1350
-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. -A score of ?15? or higher on the Female Sexual Distress Scale-Revised (FSDS-R) 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. -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. -In the investigator?s opinion, patients must be reliable, honest, compliant, and agree to cooperate with all trial evaluations as well as to be able to perform them. -Patients must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements. Patients must have sufficient understanding to communicate effectively with the investigator, and be willing to discuss their sexual functioning with the investigative staff. -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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-Assumption of any prohibited medication within 30 days before V1 -Sexual function affected by any medication within 30 days before V1 and before V2 -History of drug dependence or abuse (including alcohol) within the past 1 year -History of multiple severe reactions to psychotropic drugs -Participation in a trial within 1 month before V1 or in any trial of flibanserin -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, according to DSM-IV-TR -Peri-menopause or post menopause stage according to the STRAW criteria. -Findings at V1 of pelvic inflammatory disease, urinary tract or vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy -Pts who are breast feeding or have breastfed within the last 6 months before V2, who are pregnant or have been pregnant within the last 6 months prior to V2 -History of MDD within 6 months before V1, score of >=14 on the Beck Depression Inventory II; history of suicide attempt (Beck Scale for Suicide Ideation) and of any psychiatric disorders that could impact sexual function, safety or compliance -Ongoing non-drug psychotherapeutic treatment at V1 or stopped within 3 months before V1 Any new ones are forbidden -Major life stress or relationship discord that could interfere with sexual activity, except distress about HSDD -Clinically significant ECG abnormalities; QTc intervals >480ms, PR intervals >240ms, and QRS intervals >110ms -History of dementia or other neurodegenerative diseases, organic brain disease, stroke, TIA, brain surgery, significant brain trauma, multiple sclerosis, spinal cord injury, peripheral neuropathy, and epilepsy -Ongoing hepatic impairment (active hepatitis, cirrhosis, hepatic tumor, other hepatic disease), peptic ulcer within 6 months before V1; ALT, AST, or alkaline phosphatase >=2xULN; inflammatory bowel disease or gastrointestinal bleeding within 2 months before V1 -Hypertension (DBP>=95mm/Hg after therapy). Angina pectoris, clinically significant atherosclerotic cardiovascular disease, congestive heart failure, cardiomyopathy, symptomatic cardiac valve disease, clinically significant arrhythmia, vascular disease or any indication for or use of warfarin sodium. -History of renal failure, blood urea nitrogen >=30mg/dL, plasma creatinine >=2mg/dL, known history of chronic glomerulonephritis, sickle cell disease, anemia (Hb<9.5grams/dL), leukopenia [<2.5x10**3/microliter], neutropenia (<1.5x10**3/ microliter), lymphopenia (<0.8x10**3/ microliter), thrombocytopenia (<100x10**3/ microliter) or thrombocytosis (>500 x 10**3/ microliter), COPD, chronic bronchitis, or asthma not controlled with therapy <=twice daily, endocrinologic disorders including gonadotropic hormone disorders or undiagnosed/uncontrolled diabetes mellitus (fasting plasma glucose >=140 mg/dL and 2+ glucosuria). Controlled diabetes and no secondary sequelae of diabetes is allowed -History of uncorrected hypo- or hyper thyroidism. Pts must be euthyroid at V2 and may be taking thyroid replacement therapy if their dose is stable and their compliance is good -History of uncontrolled glaucoma. -HIV infection or AIDS, other clinically significant immunological disorders or auto immune disorders -History of cancer within the last 10 years, oth
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method