E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Vulvar and vaginal atrophy |
|
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 | 10047782 |
E.1.2 | Term | Vulvovaginal atrophy |
|
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 assess the long-term safety of 60 mg Ospemifene daily |
|
E.2.2 | Secondary objectives of the trial |
To assess efficacy of 60 mg Ospemifene daily |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subject: - has signed a written informed consent. - has agreed to follow dosing instruction and complete required study visits. - is a woman between 40 to 80 years. - is postmenopausal. - has an intact uterus. - has negative mammogram obtained at screening or within the last 3 months. - has 5% fewer superficial cells in the maturation index of the vaginal smear. - has vaginal pH greater than 5.0. |
|
E.4 | Principal exclusion criteria |
Subject has at screening: - doubble-layer endometrial tickness > or equal 4mm on endometrial ultrasound. - evidence of hyperplasia, cancer or other pathology from the endometrial biopsy. - abnormal Papanicolaou test result. - symptomatic and/or large uterine fibroids. - uteine bleeding of unknown origin. - uterine polyps. - vaginal infection. - clinically significant abnormal gynecological findings other than vaginal atrophy. - taken hormonal medications such as: a) vaginal products (within 14 days) b) oral or transdermal estrogen and/or progestin therapy (within 60 days) c) intrauterine progestin therapy (within 60 days) d) progestin implants or estrogen injectable drugs (within 90 days) e) estrogen pellet therapy or progestin injectable drugs (within 6 months) - taken selective estrogen receptor modulators, tibolone or other medications that are expected to have clinically significant estrogenic/antiestrogenic effects (within 60 days). - regularly used herbal or dietary supplements, phytoestrogens or OTC agents known to possibly have estrogenic effects (within 30 days). - clinically significant abnormal findings at physical examination, ECG and safety laboratory tests. - liver enzymes more than twice the upper limit of normal. - BMI of > or equal to 30. - systolic blood pressure > or equal to180 mmHg or diastolic blood pressure > or equal to100 mmHg. - suspicion of malignancy on mammography, clinical suspicion of any other kind of malignancy, or history of malignancy (within 10 years). - current or history of severe renal or hepatic impairment, thromboembolic or blood coagulation disorder or cerebrovascular incident.
Subject is: - using heparin, systemic itraconazole or ketoconazole or digitalis alkaloids. - heterozygous or homozygous for Factor V Leiden. - consuming more than 14 drinks containing alcohol per week.
Subject has: - been participating in another clinical intervention study within 30 days or in any clinical study of Ospemifene. - any physical or mental condition that the investigator think may interfere with the compliance of the subject.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is to get supportive data for the overall safety profile of long-term treatment with Ospemifene. |
|
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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
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 | Yes |
E.7.1.3.1 | Other trial type description |
Safety confirmatory (Phase III) |
|
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
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 | 20 |
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 | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |