DHEA Against Vaginal Atrophy (Placebo-controlled, Double-blind and Randomized Phase III Study of 3-month Intravaginal DHEA)
概览
- 阶段
- 3 期
- 干预措施
- Placebo
- 疾病 / 适应症
- Vaginal Atrophy
- 发起方
- EndoCeutics Inc.
- 入组人数
- 255
- 试验地点
- 33
- 主要终点
- Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear
- 状态
- 已完成
- 最后更新
- 8年前
概览
简要总结
The purpose of this Phase III trial is to confirm the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
研究者
入排标准
入选标准
- •Postmenopausal women (hysterectomized or non-hysterectomized)
- •Women between 40 and 75 years of age.
- •Willing to participate in the study and sign an informed consent.
- •Women who have self-identified symptom(s)of vaginal atrophy.
- •For non-hysterectomized women, willing to have endometrial biopsy at screening and end of study.
排除标准
- •Undiagnosed abnormal genital bleeding.
- •Hypertension equal to or above 140/90 mm Hg.
- •The administration of any investigational drug within 30 days of screening visit.
- •Endometrial hyperplasia, cancer or endometrial histology showing proliferative, secretory or menstrual type characteristics at histologic evaluation of endometrial biopsy performed at screening.
研究组 & 干预措施
Placebo
干预措施: Placebo
0.25% DHEA
干预措施: DHEA
0.5% DHEA
干预措施: DHEA
结局指标
主要结局
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 cell 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 the 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 Superficial Cells in the Maturation Index of the Vaginal Smear
时间窗: Baseline and Week 12
The percentage of superficial cell 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 the 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 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 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.
次要结局
- 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 Secretions(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)
- 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 Color(Baseline and Week 12)