Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A Phase II dose ranging, 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 5 mg, 15 mg and 30 mg Daily Doses with Placebo - VVA-study
- Conditions
- Vulvar and vaginal atrophy of postmenopausal womenMedDRA version: 9.1Level: LLTClassification code 10050903Term: Postmenopausal symptoms
- Registration Number
- EUCTR2007-002372-33-FI
- Lead Sponsor
- Hormos Medical Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 100
The subject is a woman 40-80 years old at the time of randomization.
The subject is postmenopausal. Postmenopausal is defined as
- at least 12 months since the last spontaneous menstrual bleeding
- hysterectomy with intact ovaries and serum FSH levels > 40 IU/L and
estradiol < 0,20 nmol/L or
- at least 6 weeks post-surgical bilateral oophorectomy.
Subject is hysterectomized or has an intact uterus with endometrial thickness < 4 mm determined by screening transvaginal ultrasound.
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 taken certain hormonal medications (listed in protocol).
Subject has clinically significant abnormal gynecological findings other than vaginal atrophy at screening.
Subject has taken a selective estrogen receptor modulator (SERM) or any other medications that are expected to have estrogenic and/or antiestrogenic vaginal effects within 60 days prior to screening.
Subject has clinically relevant abnormal findings in any safety laboratory tests.
Subject has current history of thromboembolic or blood coagulation disorder.
Subject has current history of celebrovascular 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 efficacy, safety and tolerability of 5, 15, and 30 mg of ospemifene in the treatment of VVA in postmenopausal women. ;Secondary Objective: None. ;Primary end point(s): Percentage of parabasal cells in the MI<br>Percentage of superficial cells in the MI<br>Vaginal pH
- Secondary Outcome Measures
Name Time Method