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.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 350

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.
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

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.

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 long-term safety of 60 mg Ospemifene daily;Secondary Objective: To assess efficacy of 60 mg Ospemifene daily ;Primary end point(s): The primary endpoint is to get supportive data for the overall safety profile of long-term treatment with Ospemifene.

Secondary Outcome Measures

Name	Time	Method

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