An open label, observational, non-interventional, unicentric, clinical investigation to evaluate the efficacy and safety of woman ISDIN Vaginal Moisturizer on symptomatic vaginal atrophy in 43 post menopausal woman during 12 weeks in the alleviation of vaginal atrophy symptoms

Isdin (Spain)0 个研究点目标入组 43 人开始时间: 2024年1月19日最近更新: 2024年9月9日

适应症

试验速览

暂无简介。

•1. Woman aged 18-75 years old.
•2. Postmenopausal woman (=12 months since last spontaneous menstrual period, or having 6 months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels >40 IU/L), both natural post menopause or iatrogenic conditions.
•3. At least one of the following symptoms of vaginal atrophy, assessed as moderate to severe:
•3.1. Vaginal dryness,
•3.2. Vulvovaginal irritation/itching experienced at least weekly within the past 30 days,
•3.3. Vaginal pain associated with sexual activity at least once monthly.
•4. Vulvovaginal atrophy with VHI <15.
•5. Vaginal pH >5.0
•6. Women with active sex life.

•1. Patients that present clinical signs of vaginal infections and other vaginal disorders.
•2. Patients are currently using product for Vulva Vaginal Dryness (VVD) or VDA.
•3. Patients in previous treatment with either oral or topical hormonal products within 1 month. Use of estrogens/progestins products (vaginal, oral, pellet, transdermal, etc.) in the 4 weeks to 6 months (depending on the product used) prior to study entrance.
•4. Positive history of hypersensitivity to any component of the medical device.
•5. Presence of other malignancies including cervical, ovarian, and uterine cancers.
•6. Operative history of hysterectomy or oophorectomy.
•7. Current use of medication for urogynecologic problems.
•8. Unexplained vaginal bleeding.
•9. Pregnant or breastfeeding.
•10. Not having performed any regenerative gynecology technique (laser, radiofrequency or filler insertion).

发起方

Isdin (Spain)