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 in female patients treated with flibanserin in the 511.77 parent study and to investigate the distribution of preferred dose regimens during maintenance |
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E.2.2 | Secondary objectives of the trial |
To evaluate tolerability and efficacy of flibanserin in such patients.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 updtae 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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. |
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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 | Yes |
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 | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
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 | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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.8.5.1 | Number of sites anticipated in the EEA | 84 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 24 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 24 |