A Twenty-Eight Week, Open-Label, Safety Study of Flibanserin 50 milligrams to 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
- EUCTR2007-004076-38-IT
- Lead Sponsor
- BOEHRINGER ING.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 450
-Women with a primary diagnosis of HSDD (according to the DSM-IV-TR in the parent 511.77 study), who still needs to be treated according to the investigtor?s opinion and medical history update and willing to continue in this extension study. This continuation requires adequate compliance, in the investigator?s judgement, with trial medication and the trial visits required in the parent clinical 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 Baseline Visit and continue to use that medically acceptable method of contraception during the trial. However, if the use of a contraceptive is judged to be a contributing factor to the patient's HSDD, the patient should be excluded from the trial. -The patient must be on time for scheduled visits; her medical disclosures must agree with objective information obtained during the Baseline Visit; her statements about medical history must be self-consistent and she must agree to co-operate 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 Baseline 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
-Patients with a history of MDD within 6 months prior the Baseline 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. -Patients with a history of participation in a trial of another investigational medication (except the Flibanserin parent trial) within 1 month prior to the Baseline Visit. -Patients with findings at the Baseline Visit of pelvic inflammatory disease, urinary tract or vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy. -Patients who are pregnant (by serum pregnancy test at the Baseline Visit) or have been pregnant within the month prior to the Baseline Visit. -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 Baseline Visit, according to the investigator?s 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. -At Baseline Visit, serum aspartate aminotransferase, or alkaline phosphatase >= two times upper limit of normal, blood urea nitrogen >=30 mg/deciliter (dL), plasma creatinine >= 2 mg/dL. Patients with a history of coagulation disorders, abnormal tendency to bleed, sicke cell disease, anemia (hemoglobin <9.5 grams/dL), leukopenia [<2.5 x 10**3/microL], neutropenia (<1.5 x 10**3/microL), lymphopenia (<0.8 x 10**3/microL), thrombocytopenia (<100 x 10**3/microL) or thrombocytosis (>500 x 10**3/microL), or fasting plasma glucose >=140 mg/dL and 2+ glucosuria. -Patients receiving medication that were excluded in their parent safety and efficacy trial of flibanserin (within the same time frame before the Baseline Visit), i.e., causing sexual dysfunction or safety-relevant interactions (e.g., antidepressants, anxiolytics, antipsychotics, mood stabilizers, anticonvulsants, anticoagulants). -At the Baseline Visit, patients with a history of cancer within the last 10 years, other than non-invasive, previously resected skin cancer.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To document the safety profile of flibanserin over 28 additional weeks of treatment in female patients treated with flibanserin in the 511.77 parent study.;Secondary Objective: To evaluate tolerability and efficacy of flibanserin in HSDD patients;Primary end point(s): The primary endpoint is the proportion of patients with the common, expected AE to flibanserin individually and collectively; the proportion of discontinuations due to AEs; and the proportion of serious AEs (SAEs) related to study medication
- Secondary Outcome Measures
Name Time Method