| 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 establish efficacy of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in 6-month treatment, vs placebo for Hypoactive Sexual Desire Disorder in premenopausal European women. |
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| E.2.2 | Secondary objectives of the trial |
To evaluate safety and tolerability 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 who are 18 years of age and older at the Screen Visit.
2. 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
3. A score of “15” or higher on the Female Sexual Distress Scale-Revised (FSDS-R)© at the Screen Visit.
4. Item Number Two of the Sexual Interest and Desire Inventory - Female© (SIDI-F©) must be rated as "0" or "1" at the Screen Visit.
5. Patients must be willing to try to have sexual activity (e.g., any act involving direct genital stimulation) at least once monthly.
6. Patients must be willing and able to use an eDiary on a daily basis (e.g., have access to a working land line telephone for daily data transmissions).
7. 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.
8. 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.
9. 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 Screen 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.
10. In the investigator’s opinion, patients must be reliable, honest, compliant, and agree to co-operate with all trial evaluations as well as to be able to perform them.
11. 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.
12. 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.
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| E.4 | Principal exclusion criteria |
3. Patients with a history of drug dependence or abuse (including alcohol, as defined in DSM IV-TR or in the opinion of the investigator) within the past 1 year.
6. Patients who meet DSM IV-TR criteria for 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.
7. Patients who indicate that their sexual partner has organic or psychosexual dysfunction that could interfere with a patient’s response to treatment.
8. Patients who have entered the peri-menopause stage (menopausal transition) or the post menopause stage according to the STRAW criteria.
9. Patients with findings at the Screen Visit of pelvic inflammatory disease, urinary tract or vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy.
10. Patients who are breast feeding or have breastfed within the last six months prior to the Baseline Visit.
11. Patients who are pregnant (by serum pregnancy test at the Screen Visit) or have been pregnant within the last 6 months prior to the Baseline Visit.
12. 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®.
13. Patients with a history of any other psychiatric disorders that could impact sexual function, risks patient's safety, or may impact compliance.
14. Patients who are ongoing psychotherapeutic treatment at the screen visit or who stopped psychotherapeutic (non-drug) treatment within 3 months before the Screen Visit. Any new psychotherapeutic treatments are forbidden during the study.
16. 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,
17. Neurologic: Patients with a history of dementia or other neurodegenerative diseases, organic brain disease, stroke, transient ischemic attacks, brain surgery, significant brain trauma, multiple sclerosis, spinal cord injury, peripheral neuropathy, and epilepsy (febrile seizures limited to childhood do not exclude patients),
18. Gastrointestinal and Hepatic: Patients with ongoing hepatic impairment (active hepatitis, cirrhosis, hepatic tumor, or other hepatic disease), peptic ulcer within 6 months prior to the Screen Visit; serum alanine aminotransferase, serum aspartate aminotransferase, or alkaline phosphatase two times upper limit of normal; inflammatory bowel disease, or gastrointestinal bleeding within 2 months before the Screen Visit [e.g., melena, hematemesis, hematochezia, or presumptive (i.e., iron deficiency anemia of unknown origin)],
19. Cardiovascular: Patients with hypertension defined as diastolic blood pressure >=95 millimeters (mm) of mercury (Hg), after treatment. Whether treated or not: 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,
20. Renal: Patients with a history of renal failure, blood urea nitrogen>=30 mg/deciliter (dL), plasma creatinine>= 2 mg/dL, known history of chronic glomerulonephritis,
21. Hematologic: Patients with a history of 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),
22. Respiratory disease: Patients with a history of chronic obstructive pulmonary disease, chronic bronchitis, or asthma not well controlled with medication twice daily or less frequently,
23. Patients with a history of endocrinologic disorders
24. Patients with a history of uncorrected hypo- or hyper thyroidism. Patients must be clinically and biochemically euthyroid at the time of randomization. Patients may be taking thyroid replacement therapy if their dose is stable and their compliance is good for at least 3 months,
25. Patients with a history of uncontrolled glaucoma,
26. Patients with known Human Immunodeficiency Virus infection or Acquired Immunodeficiency Syndrome, other clinically significant immunological disorders or auto immune disorders (e.g., lupus erythematosus, scleroderma, etc.), and
27. 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 change from baseline in the frequency of satisfying sexual events as mesured by the eDiary. The comparison will be made between the four week baseline period and Week 21 to 24. |
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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 | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Information not present in EudraCT |
| E.8.1.3 | Single blind | Information not present in EudraCT |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | Information not present in EudraCT |
| E.8.1.7 | Other | Information not present in EudraCT |
| 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 | Yes |
| 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 | 11 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 75 |
| 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 | Yes |
| 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 |
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