Topical DHEA Against Vaginal Atrophy (3-Month Placebo-Controlled Double-Blind Randomized Phase III Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 8
- 主要终点
- Co-primary Endpoint: Change From Baseline to Week 12 of Self-assessment of the Most Bothersome Symptom Dyspareunia
研究概览
简要总结
The purpose of this study is to determine the dose-response of vaginal mucosa parameters to the local action of DHEA (Dehydroepiandrosterone) in postmenopausal women suffering from vaginal atrophy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women (non hysterectomized or hysterectomized)
- •Women between 40 and 75 years of age
- •Willing to participate in the study and sign an informed consent
- •Women having a low maturation index (no greater part of guidance than 5% of superficial cells on vaginal smear)
- •Women having a vaginal pH above 5
- •Women who have self-identified at least one moderate to severe symptoms of vulvovaginal atrophy
排除标准
- •Undiagnosed abnormal genital bleeding
- •Hypertension equal to or above 160/95 mm Hg or not controlled by standard therapy
- •The administration of any investigational drug within 30 days of screening visit
- •Endometrial hyperplasia at biopsy performed at screening or endometrial cancer
- •Use of estrogens/progestins products (vaginal, oral, pellet, transdermal, etc) in the 4 weeks to 6 months (depending on the product used) prior study entry
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
0.25% DHEA
干预措施: DHEA (0.25%) (Drug)
0.5% DHEA
干预措施: DHEA (0.5%) (Drug)
1.0% DHEA
干预措施: DHEA (1.0%) (Drug)
结局指标
主要结局
Co-primary Endpoint: Change From Baseline to Week 12 of Self-assessment of the Most Bothersome Symptom Dyspareunia
时间窗: Baseline and Week 12
The severity of dyspareunia was evaluated by a questionnaire. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells)
时间窗: Baseline and Week 12
The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH.
时间窗: Baseline and Week 12
A pH strip was applied directly to the lateral wall of the vagina using forceps. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Superficial Cells)
时间窗: Baseline and Week 12
The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
次要结局
- Change From Baseline to Week 12 of Vaginal Secretions(Baseline and Week 12)
- Change From Baseline to Week 12 of Vaginal Epithelial Integrity(Baseline and Week 12)
- Change From Baseline to Week 12 of Vaginal Color(Baseline and Week 12)
- Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness(Baseline and Week 12)