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
干预措施
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
研究组 & 干预措施
WO 2707
Experimental
Formulation containing WO 2707 for intravaginal application
干预措施: WO 2707 (Device)
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
- Participants with premature trial termination due to adverse device effects, adverse events, concomitant medication(From baseline to visit 4 (day 44))
- 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))
研究者
研究点 (1)
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