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

Hormos Medical Ltd0 个研究点目标入组 100 人开始时间: 2007年5月11日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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.

发起方

Hormos Medical Ltd