E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Primary generalized acquired Hypoactive Sexual Desire Disorder in Premenopausal women |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020933 |
E.1.2 | Term | Hypoactive sexual desire disorder |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
To evaluate tolerability and efficacy of flibanserin in HSDD patients |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-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 investigtors opinion and medical history update and willing to continue in this extension study. This continuation requires adequate compliance, in the investigators 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. |
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E.4 | Principal exclusion criteria |
-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 investigators 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. |
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |