Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 30 and 60 Mg Daily Doses With Placebo
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 826
- 主要终点
- Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear
研究概览
简要总结
The purpose of this study is to determine whether ospemifene is more effective than placebo in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Naturally or surgically postmenopausal
- •Moderate or severe symptoms of vaginal atrophy (ie, vaginal dryness, irritation or itching, difficult or painful urination, pain or bleeding with intercourse)
- •Vaginal pH greater than 5.0
- •5% or fewer superficial cells in maturation index of vaginal smear
排除标准
- •Evidence of endometrial hyperplasia, endometrial cancer, or other abnormal endometrial pathology
- •Abnormal Pap smear
- •Uterine bleeding of unknown origin or uterine polyps
- •Current vaginal infection requiring medication
研究组 & 干预措施
Ospemifene 30 mg/day and nonhormonal vaginal lubricant
Subjects will receive a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2.
干预措施: Ospemifene 30 mg (Drug)
Ospemifene 30 mg/day and nonhormonal vaginal lubricant
Subjects will receive a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2.
干预措施: Nonhormonal vaginal lubricant (Drug)
Ospemifene 60 mg/day and nonhormonal vaginal lubricant
Subjects will receive a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2.
干预措施: Ospemifene 60 mg (Drug)
Ospemifene 60 mg/day and nonhormonal vaginal lubricant
Subjects will receive a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2.
干预措施: Nonhormonal vaginal lubricant (Drug)
Placebo tablets and nonhormonal vaginal lubricant
Subjects will receive a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2.
干预措施: Placebo (Drug)
Placebo tablets and nonhormonal vaginal lubricant
Subjects will receive a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2.
干预措施: Nonhormonal vaginal lubricant (Drug)
结局指标
主要结局
Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear
时间窗: Baseline (Screening) to Week 12
Mean Change From Baseline in the Percentage of Superficial Cells in Maturation Index of Vaginal Smear
时间窗: Baseline (Screening) to Week 12
Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness
时间窗: Baseline (Randomization) to Week 12
This outcome measure was analyzed using Cochran-Mantel-Haenszel (CMH) row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
Mean Change From Baseline in the MBS of Vaginal Pain Associated With Sexual Activity
时间窗: Baseline (Randomization) to Week 12
This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
Mean Change From Baseline in Vaginal pH
时间窗: Baseline (Screening) to Week 12
次要结局
- Change From Baseline in Visual Evaluation of the Vagina(Baseline (Screening) to Week 12)
- Change From Baseline in Severity of VVA Symptoms(Baseline (Randomization) to Week 12)
- Change From Baseline in Estradiol Levels(Baseline (Screening) to Week 12)
- Change From Baseline in Follicle Stimulating Hormone Levels(Baseline (Screening) to Week 12)
- Change From Baseline in Luteinizing Hormone Levels(Baseline (Screening) to Week 12)
- Change From Baseline in Sex Hormone Binding Globulin Levels(Baseline (Screening) to Week 12)
- Change From Baseline in Testosterone (Free) Levels(Baseline (Screening) to Week 12)
- Change From Baseline in Testosterone (Total) Levels(Baseline (Screening) to Week 12)
- Change From Baseline in Urinary Symptoms(Baseline (Randomization) to Week 12)