E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Vulvar and vaginal atrophy of postmenopausal women |
|
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 efficacy and long-term safety of ospemifene to support the overall safety profile of ospemifene in the treatment of VVA. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The subject is a woman 40 to 80 years old at the time of randomization.
The subject is postmenopausal.
Subject has an intact uterus.
The subject has 5% or fewer superficial cells in the maturation index of the vaginal smear
The subject has vaginal pH greater than 5.0
|
|
E.4 | Principal exclusion criteria |
Subject has double-layer endometrial thickness ≥4 mm on endometrial ultrasound at screening.
Subject has evidence of hyperplasia, cancer or other pathology from the endometrial biopsy at screening.
Subject has abnormal Papanicolaou test result at screening.
Subject has clinically significant abnormal gynecological findings other than signs of vaginal atrophy.
Subject has taken certain hormonal medications (lited in protocol).
Subject has taken selective estrogen receptor modulator (SERM) or any other medications that are expected to have clinically significant estrogenic and/or antiestrogenic effects within 60 days prior to screening.
Subject has clinically significant abnormal findings at physical examination at screening.
Subject is heterozygous or homozygous for Factor V Leiden (test done at screening).
Subject has current or history of thromboembolic or blood coagulation disorder.
Subject has current or history of cerebrovascular incident. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline to Week 12 in the following:
• Percentage of parabasal cells in the MI
• Percentage of superficial cells in the MI
• Vaginal pH
|
|
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 | 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 | 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 | 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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
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 | 0 |
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 |
E.8.9.2 | In all countries concerned by the trial days | 0 |