Randomised, double-blind, placebo-controlled trial assessing the efficacy of Mi-Gel in the treatment of women with entry dyspareunia

Women's Health & Research Institute of Australia0 个研究点目标入组 80 人开始时间: 2019年8月20日最近更新: 2021年11月29日

适应症

试验速览

暂无简介。

•1. Aged less than 18
•2. Not sexually active
•3. Current use of amitriptyline or oestriol (topical or oral)
•(Patients would be suitable for inclusion after a wash out period of six weeks)
•4. Pudendal Nerve Block procedure within the last three months or planning on having a Pudendal Nerve Block procedure during the course of the trial
•5. Known allergy to amitriptyline or oestriol
•6. Contraindication to use of amitriptyline or oestriol
•7. Pregnant or unwilling to use methods to avoid potential pregnancy, as determined by a urine test
•8. Other peri-vaginal infections or vulvovaginal disorders including current acute/chronic candidiasis or active DIV/psoriasis/lichen sclerosis
•9. Endometrial hyperplasia or undiagnosed genital bleeding
•10. Previous myocardial infarction, thrombosis, breast cancer, cancer of any sexual organs, liver disease and/or porphyria
•11. History of chemotherapy or radiation therapy
•12. Lack of lubrication due to chronic conditions such as diabetes mellitus, atherosclerosis or auto-immune disorders
•13. Current diagnosis of vaginismus
•14. The investigator believes the candidate would not make a good clinical trial patient

发起方

Women's Health & Research Institute of Australia