A double-blinded, randomised, placebo-controlled trial of the efficacy of the MonaLisa Touch procedure for the treatment of postmenopausal vulvovaginal symptoms

GRACE Unit - School of Women's and Children's Health, UNSW Sydney, Australia0 个研究点目标入组 94 人开始时间: 2016年10月10日最近更新: 2021年12月6日

试验速览

暂无简介。

•Symptomatic women with any of 1-5:
•1.Post-menopausal women who have not had a menstrual period for at least 12 months (with an intact uterus) and/or have vulvovaginal symptoms substantial enough for them to present to their health care provider due to symptoms
•2.Women who have previously trialled topical intra-vaginal oestrogen preparations without alleviation of symptoms or with side effects to the treatment
•3.Women who have contraindications to topical intra-vaginal oestrogen preparations.
•4.Women who have previously had a hysterectomy and have vaginal atrophy symptoms and have an elevation of FSH (>30) consistent with a post-menopausal state.
•5.Women who have symptoms of vaginal atrophy and do not wish to use topical oestrogen.
•AND have symptoms including one or more of: vaginal dryness; vaginal burning; vaginal itching; dyspareunia or dysuria.

•1.Use of systemic or local hormone replacement therapy in the six months prior to study intervention
•2.Use of vaginal moisturisers or other preparations in the 30 days prior to study intervention.
•3.Current urinary tract infection.
•4.Active genital infections.
•5.Current genital herpes infection.
•6.Pelvic organ prolapse (most substantial prolapse) POPQ system stage 2.
•7.Previous vaginal prolapse surgery where there is mesh repair in the pelvis.
•8.Chronic disease states which will interfere with compliance to study

发起方

GRACE Unit - School of Women's and Children's Health, UNSW Sydney, Australia