Open-Label Vulvoscopy Photography Study of Changes in Vulva, Vestibule, Urethral Meatus and Vagina 20 Weeks Post Daily Administration of 6.5 Mg Vaginal Prasterone in Menopausal Women With Moderate to Severe Dyspareunia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Vulvoscopic changes to the vulva, vestibule, urethral meatus and vaginal region on VGTA scale
研究概览
简要总结
Open label study at a single research center. Subjects meeting inclusion and exclusion criteria will receive 6.5 mg prasterone vaginal inserts daily for twenty weeks. A physical examination and vulvoscopy with photography of the vulva, vestibule, urethral meatus and vagina will be performed at baseline and every 4 weeks for 20 weeks. Pain diaries will be completed between visits.
详细描述
This is an open label study to be conducted at a single research center, San Diego Sexual Medicine. Subjects meeting inclusion and exclusion criteria will receive 6.5 mg prasterone vaginal inserts daily for twenty weeks. After the informed consent is signed, a baseline physical examination and vulvoscopy with detailed photography of the vulva, vestibule, urethral meatus and vagina will be performed. Physical examination and vulvoscopy with detailed photography of the vulva, vestibule, urethral meatus and vagina will be repeated prospectively every 4 weeks for a total of 20 weeks. Therefore, physical examination and vulvoscopy with detailed photography of the vulva, vestibule, urethral meatus and vagina will be performed prospectively at baseline (vulvoscopy session 1), 4 weeks (vulvoscopy session 2), 8 weeks (vulvoscopy session 3), 12 weeks (vulvoscopy session 4), 16 weeks (vulvoscopy session 5) and 20 weeks (vulvoscopy session 6) following daily administration of 6.5 mg prasterone. In addition, pain diaries will be dispensed at each visit and collected at the following visit, with questions regarding pain during sexual activity.
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
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •provides written informed consent and HIPAA authorization before any study procedures are conducted;
- •has a body mass index (BMI) < 37 kg/m2
- •is menopausal either naturally (at least 12 months amenorrheic) or 6 weeks after a bilateral salpingo-oophorectomy prior to natural menopause; subjects with hysterectomy only must have a serum FSH > 40 mIU/mL;
- •has vulvovaginal atrophy with moderate to severe dyspareunia;
- •has at least one score ≥ 2 on cotton-tipped swab test
- •agrees to comply with the study procedures and visits.
排除标准
- •has a hypersensitivity to DHEA;
- •has used prasterone in the past 6 months;
- •has documented or suspected breast cancer;
- •has undiagnosed genital bleeding:
- •has clinically significant findings on physical examination;
- •has uncontrolled hypertension;
- •has any chronic medical condition or psychologic disorder that the Principal Investigator feels makes her ineligible for the study;
- •is currently on local or systemic androgen therapy including local or systemic testosterone (washout 14 days for local or topical androgen or non-depot injection, 1 month for depot, 6 months for pellet;
- •is currently on local or systemic estrogen therapy or androgen therapy (washout 14 days for vaginal estrogen, 60 days for oral/transdermal therapy);
- •is currently using a selective estrogen receptor modulator (SERM) or products that have estrogenic or anti-estrogenic effects within last month;
- •has a history of substance abuse within 12 months prior, or consuming > 14 alcoholic drinks per week;
- •has received an investigational drug within 30 days prior to signing consent;
- •has any condition or exhibits behavior that indicates to the Principal Investigator that the Subject is unlikely to be compliant with study procedures and visits.
研究组 & 干预措施
Prasterone
6.5 mg vaginal inserts of prasterone will be used daily once the patient meets inclusion and exclusion for 20 weeks.
干预措施: Prasterone (Drug)
结局指标
主要结局
Vulvoscopic changes to the vulva, vestibule, urethral meatus and vaginal region on VGTA scale
时间窗: Twenty weeks
The primary objective of this study is to prospectively document, using vulvoscopy with detailed photography, the visible changes to the vulva, vestibule, urethral meatus and vaginal region in menopausal women with moderate to severe dyspareunia using 6.5 mg daily prasterone for twenty weeks, comparing baseline to 20 weeks. Photographs will be assessed by an independent reviewer using a ten-parameter Likert rating scale, the Vulvoscopic Genitourinary Tissue Appearance (VGTA) scale. This scale assesses for labia majora resorption, labia minora resorption, clitoral atrophy, urethral meatal prolapse, introital stenosis, pallor, erythema, mucosa inflammation, loss of vaginal ruggation, and anterior vaginal wall atrophy. VGTA values for each parameter are 0 (normal), 1(mild), 2 (moderate) or 3 (severe). Each parameter will be calculated separately as well as the total score as primary outcome measure.
次要结局
- Subject diary(Twenty weeks)
- Changes in pain as noted on cotton-tipped swab (Q-tips®) test.(Twenty weeks)