Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 558
- 试验地点
- 38
- 主要终点
- Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia
研究概览
简要总结
The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on symptoms of vulvovaginal atrophy due to menopause and to collect further data on subjects exposed to intravaginal DHEA in order to meet the ICH E1 guideline requirements.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Main criteria:
- •Postmenopausal women (hysterectomized or not)
- •Women between 40 and 80 years of age
- •Women having ≤5% of superficial cells on vaginal smear at baseline
- •Women having a vaginal pH above 5 at baseline
- •Women who have self-identified moderate or severe symptom(s) of vaginal atrophy
- •Willing to participate in the study and sign an informed consent
排除标准
- •Main criteria:
- •Previous enrollment in EndoCeutics studies performed with intravaginal DHEA
- •Previous diagnosis of cancer, except skin cancer (non melanoma)
- •Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication
- •The administration of any investigational drug within 30 days of screening visit
- •Clinically significant abnormal serum biochemistry, urinalysis or hematology
研究组 & 干预措施
Placebo
Placebo vaginal ovule daily for 12 weeks
干预措施: Placebo (Drug)
Prasterone
Prasterone (DHEA) vaginal ovule daily for 12 weeks
干预措施: Prasterone (DHEA) (Drug)
结局指标
主要结局
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia
时间窗: Baseline and Week 12
The severity of dyspareunia was evaluated by a questionnaire filled out by women. 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.
Change From Baseline to Week 12 in Vaginal pH
时间窗: Baseline and Week 12
A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. 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.
Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear
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.
Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear
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.
次要结局
- Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions(Baseline and Week 12)
- Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color(Baseline and Week 12)
- Change From Baseline to Week 12 in Severity of Vaginal Dryness(Baseline and Week 12)
- Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness(Baseline and Week 12)
- Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity(Baseline and Week 12)