DHEA Against Vaginal Atrophy - Safety Study of 12 Months
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 530
- 试验地点
- 41
- 主要终点
- Long-term Safety of Intravaginal Prasterone (DHEA): Serum Steroid Levels
研究概览
简要总结
The purpose of this Phase III trial is to assess the long-term safety of intravaginal dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal atrophy aged 40 to 75 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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)
- •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.
- •Willing to have endometrial biopsy at screening and end of study (Week 52).
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
DHEA
0.5% DHEA (intravaginal)
干预措施: DHEA (Drug)
结局指标
主要结局
Long-term Safety of Intravaginal Prasterone (DHEA): Serum Steroid Levels
时间窗: Baseline and Week 52
The long-term safety of intravaginal prasterone has been evaluated on different parameters including the serum levels of DHEA and its metabolites. For this purpose, blood samples were collected at Baseline and different post-Baseline timepoints for the determination of serum steroid levels by a central laboratory using validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methods. The serum levels of dehydroepiandrosterone (DHEA), estradiol (E2) and testosterone (TESTO) obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.
Long-term Safety of Intravaginal Prasterone (DHEA): Endometrium
时间窗: Baseline and Week 52 (or discontinuation)
The long-term safety of intravaginal prasterone has been evaluated on different parameters including the endometrium. For this purpose, endometrial biopsies were performed at screening and at the end of the study (52 weeks) or at discontinuation visit for women who were exposed to intravaginal DHEA (prasterone) for at least 12 weeks. At screening, the endometrium had to be atrophic/inactive for women to be enrolled in the study. Only the end-of-study data are presented.
次要结局
- Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Superficial Cells).(Baseline and Week 52)
- Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Parabasal Cells).(Baseline and Week 52)
- Change From Baseline to Week 52 of Vaginal pH.(Baseline and Week 52)
- Change From Baseline to Week 52 of Self-assessment of VVA Symptom Dyspareunia(Baseline and Week 52)
- Change From Baseline to Week 52 of Self-assessment of VVA Symptom Vaginal Dryness(Baseline and Week 52)
- Change From Baseline to Week 52 of Self-assessment of VVA Symptom Irritation/Itching(Baseline and Week 52)