EUCTR2007-002939-90-SE进行中（未招募）不适用
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.
Hormos Medical Ltd0 个研究点目标入组 350 人开始时间: 2007年10月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 350
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •- 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
排除标准
- •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.
研究者
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