Efficacy and Long-Term Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A 52-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing 60 mg Oral Daily Dose of Ospemifene with Placebo - 52 wks VVA study
- Conditions
- Vulvar and vaginal atrophy of postmenopausal womenMedDRA version: 9.1Level: LLTClassification code 10047782Term: Vulvovaginal atrophy
- Registration Number
- EUCTR2007-002939-90-DK
- Lead Sponsor
- Hormos Medical Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 350
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy and long-term safety of ospemifene to support the overall safety profile of ospemifene in the treatment of VVA.;Secondary Objective: None.;Primary end point(s): Change from baseline to Week 12 in the following: <br><br>•Percentage of parabasal cells in the MI <br>•Percentage of superficial cells in the MI <br>•Vaginal pH<br>
- Secondary Outcome Measures
Name Time Method