NCT04887701已完成不适用
Clinical Outcomes and Safety of a Non-hormonal Medical Device Versus a Sham Device on the Treatment of Vulvovaginal Atrophy (VVA) in Post-Menopausal Women Who Have Failed, Refused, or Are Contraindicated for Hormone Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Madorra
- 入组人数
- 25
- 试验地点
- 6
- 主要终点
- Patient Reported VAS Score
研究概览
简要总结
Randomized (1:1), double-blind, sham-controlled, 2-arm parallel study comparing effectiveness and safety of non-hormonal medical device versus sham device to treat VVA in post-menopausal women.
详细描述
After screening and baseline assessment, participants, ages 21 to 65 years of age, will be randomized and followed for a 12-week intervention period. After the primary endpoint evaluation at week 12, each participant in both arms will immediately commence an open label period using an Active device for week 13 to 1 year to collect further effectiveness and safety data.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with menopause defined by last menstrual period at least 12 months prior to screening, or 6 months of amenorrhea with serum FSH levels > 40 mIU/ml, or 8 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
- •Sexually active women.
- •Participant experiencing subjective moderate-to-severe vaginal pain with sexual intercourse.
- •Participant experiencing subjective moderate-to-severe vaginal dryness.
- •Gynecological exam confirming vaginal atrophy.
- •Willingness to give voluntary written informed consent to participate in the study and comply with protocol requirements.
排除标准
- •Use of systemic or local estrogen therapy, currently or in the last 6 months or planned use during the study.
- •Use of any other treatment for vaginal atrophy, 6 weeks prior to enrollment or planned during the study period.
- •Investigational drugs and also prescription and nonprescription medications/remedies known to treat VVA within 60 days of enrollment or during the study.
- •Vaginal stenosis.
- •Pelvic floor disorders.
- •Prior pelvic radiation therapy including radiation or surgery to the vulva/vagina.
- •Active urinary tract, yeast, or other active gynecologic infections.
- •Active connective tissue disorders such as lupus or Sjogren's syndrome.
- •Active malignancies.
- •Diagnosis of vulvodynia or other pelvic pain in the vagina or vulvar area.
- •Vulvar dermatoses.
- •Laser or radio frequency vaginal rejuvenation treatment or planned treatment during the study.
- •Any medical condition that, in the investigator's opinion, would interfere with their participation and/or completion in the study.
结局指标
主要结局
Patient Reported VAS Score
时间窗: Baseline to 12 weeks
Mean change in the Vaginal Assessment Scale (VAS). The VAS is a scale from 0 to 3 with 0 being no symptoms and 3 being severe symptoms.
Clinician Assessed Changes in VVA
时间窗: Baseline to 12 weeks
Will determine by comparing the mean change between the two arms of the study in clinician assessed changes of VVA by the Vaginal Health Index (VHI). The VHI gives a numerical score (1-5) for each of the 5 parameters measured: issue elasticity, vaginal fluid, PH, mucosa, and vaginal moisture.
次要结局
- Responder Rate PGI-I(12 weeks)
研究者
研究点 (6)
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