NCT05211505已完成4 期
Prospective, Open-label Trial Investigating the Efficacy and Tolerability of WO 2707, a MoistCream Cremolum, in Postmenopausal Women Suffering From Symptoms of Vaginal Dryness
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Change of TSS (Total severity score) for subjective symptoms of atrophy
研究概览
简要总结
The objective of the clinical investigation is to evaluate the efficacy and tolerability of WO 2707, a MoistCream Cremolum, with respect to the application in postmenopausal women with symptoms of vaginal dryness.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Post-menopausal women with the subjective symptomatology of vulvovaginal atrophy with a sum score (0-16) of the parameters dryness, itching, burning and pain unrelated to sexual intercourse of at least 3 AND a score of at least "2" (moderate) for the parameter dryness at screening and visit 1 (day 1)
- •Thereof at least for 48 included patients: sexual activity with dyspareunia
- •Thereof at least 32 included sexually active patients with at least moderate (score of "2") dyspareunia
- •Natural cessation of last menstruation more than 12 months before screening OR bilateral oophorectomy with or without hysterectomy more than 3 months before screening
- •Signed written informed consent before participation in the clinical investigation
排除标准
- •Vaginal inflammation which is not caused by vulvovaginal atrophy
- •Non-healed vaginal surgery
- •Systemic hormonal replacement therapy (tablets, patches, injections, dermal products), or phytohormonal therapy or use of SERMs (selective estrogen receptor modulators) within 3 months before visit 1 (day 1) and / or during the conduct of this clinical investigation
- •Local hormonal therapy (vagina/vulva) within 3 months before Screening (also when used for the brightening/pretreatment of cytological smears)
- •Any use of products (including lubricants), other than the investigational medicinal device, applied intravaginally or on the vulva during the clinical investigation (except usual cleansing products)
- •Systemic corticosteroids within 21 days before visit 1 (day 1) and during the conduct of this clinical investigation (corticoid asthma sprays are allowed)
- •Use of antibiotics, antiseptics or antimycotics with expected or suspected systemic or vaginal/vulvar bioavailability within 21 days before visit 1 (day 1) and / or during this clinical investigation
- •Known hypersensitivity against any of the ingredients of the investigational medical device
- •Employees of the investigation sites who are directly involved in this clinical investigation or employees of the sponsor's company
结局指标
主要结局
Change of TSS (Total severity score) for subjective symptoms of atrophy
时间窗: From baseline to visit 3 (day 38)
The severity of each of the subjective symptoms dryness, itching, burning and pain unrelated to sexual intercourse will be assessed according to the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe The total severity score will be calculated as the sum score of the subjective symptoms resulting in a minimum score of 0 (best) and a maximal score of 16 (worst).
次要结局
- Change of TSS (Total severity score) for subjective symptoms of atrophy(From baseline to visit 2 (day 8), visit 2 (day 8) to visit 3 (day 38) and visit 3 (day 38) to visit 4 (day 44))
- Change of severity scoring for each of the subjective symptoms (dryness, itching, burning and pain unrelated to sexual intercourse)(From baseline to visit 2 (day 8) and visit 3 (day 38), visit 2 (day 8) to visit 3 (day 38) and visit 3 (day 38) to visit 4 (day 44))
- Change of each DIVA domain score (A - D) and change of total DIVA score (excluding questions 12 to 15)(From baseline to visit 3 (day 38))
- Change of each DIVA domain score (A - D) and change of total DIVA score in the subgroup of sexually active women with dyspareunia(From baseline to visit 3 (day 38))
- Change of each single parameter and of sum score over objective assessment of VHI(From baseline to visit 3 (day 38))
- Change of vaginal pH(From baseline to visit 3 (day 38))
- Patient questionnaire(Day 3, visit 3 (day 38), visit 4 (day 44))
- Change of severity scoring for dyspareunia for the subgroup of sexually active women with dyspareunia(From baseline to visit 2 (day 8) and visit 3 (day 38), visit 2 (day 8) to visit 3 (day 38) and visit 3 (day 38) to visit 4 (day 44))
- Change of impairment of daily life due to dyspareunia (VAS) for the subgroup of sexually active women with dyspareunia(From baseline to visit 2 (day 8) and visit 3 (day 38), visit 2 (day 8) to visit 3 (day 38) and visit 3 (day 38) to visit 4 (day 44))
- Global judgement of efficacy by the investigator(On visit 3 (day 38))
- Global judgement of efficacy by the patient(On visit 3 (day 38))
- Global judgement of tolerability by the investigator(On visit 3 (day 38))
- Global judgement of tolerability by the patient(On visit 3 (day 38))
- Participants with premature trial termination due to adverse device effects, adverse events, concomitant medication(From baseline to visit 4 (day 44))
研究者
研究点 (1)
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