A Twenty Eight –Week, Open-Label, Safety Study of Flibanserin 50 milligrams to 100 milligrams dailyin Premenopausal European Women With Hypoactive Sexual Desire Disorder - Magnolia

• Conditions: Primary generalized acquired Hypoactive Sexual Desire Disorder in Premenopausal women; MedDRA version: 9.1Level: LLTClassification code 10020933Term: Hypoactive sexual desire disorder

• Registration Number: EUCTR2007-004076-38-SE
• Lead Sponsor: Boehringer Ingelheim AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-08
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 450

Inclusion Criteria

1. Women with the primary diagnosis of HSDD in the 511.77 parent study who still needs to be treated according to the investigator's opinion and medical history update and willing to continue in this extension study.
2. 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) and 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.
3. The patient must be on time for scheduled visits and agree to co-operate with all trial evaluations as well as to be able to perform them.
4. 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.
5. 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

Exclusion Criteria

1. 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®.
2. 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.
3. Patients who are pregnant (by serum pregnancy test at the Baseline Visit) or have been pregnant within the month prior to the Baseline Visit.
6. Clinically significant ECG abnormalities at the Screen 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,
7. At baseline, Serum aspartate aminotransferase or alkaline phosphatase >= two times upper limit of normal, blood urea nitrogen >= 30 mg/dL, plasma creatinine>=3mg/dL. Patients with a history of coagulation disorders, abnormal tendency to bleed, sickle cell disease, anemia (hemoglobin <9.5 grams/dL), leukopenia [<2.5 x 103/microliter], neutropenia (<1.5 x 103/microliter), lymphopenia (<0.8 x 103/microliter), thrombocytopenia (<100 x 103/microliter) or thrombocytosis (>500 x 103/microliter),
9.Patients with a history of breast cancer and other 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 in female patients treated with flibanserin in the 511.77 parent study and to investigate the distribution of preferred dose regimens during maintenance;Secondary Objective: To evaluate tolerability and efficacy of flibanserin in such patients.<br>;Primary end point(s): The primary endpoint is the proportion of patien,ts with the common, expected AE to flibanserin individually adn collectively; the proportion of discontinuations due to AEs; and the proportion of serious AEs(SAEs) related to study medication.