An exploratory, double blind, randomized, parallel group, placebo controlled, multicentric study to evaluate the efficacy and safety of ProvestraTM in female sexual dysfunction (FSD).

eading Edge MarketingPO Box CR-56766, Suite 1210Nassau Bahamas0 个研究点目标入组 60 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Sexually active female aged between 21-55 yrs, in a stable monogamous relationship with a male partner for at least 6 months and who has been involved in sexual intercourse over the last four weeks
•Females who have mixed desire / arousal /orgasm disorder and are distressed due to it since at least 3 months
•Females with a baseline FSFI score of ≤ 20 and/or a domain score of <3 in at least 1 domain
•Willing to attempt sexual activity at least twice a week during the study period.

•Women whose sexual dysfunction is limited to certain types of stimulation, situation or specific partners.
•BMI > 40 kg/m2
•Evidence of unresolved sexual trauma or abuse.
•Primary anorgasmia, vaginismus, sexual pain disorder, sexual aversion disorder, or persistent sexual arousal disorder.
•?Female sexual dysfunction caused by untreated endocrine disease, e.g., hypopituitarism, hypothyroidism, diabetes mellitus; Hyperprolactinemia
•Chronic or complicated urinary tract or vaginal infections within previous 12 months (as determined by history).
•Pelvic inflammatory disease within previous 12 months.
•Currently active sexually transmitted disease.
•Chronic dyspareunia not attributable to vaginal dryness within previous 12 months.
•Currently active moderate to severe vaginitis.
•Cervical dysplasia within previous 12 months.
•Significant cervicitis as manifested by mucopurulent discharge from the cervix.
•Significant gynecologic conditions such as uterine fibroids, vulvar vestibulitis, or vaginismus that may (in the investigator?s opinion) interfere with the subject?s ability to comply with study procedures.
•Psychoses, bipolar and anxiety disorders.
•History or evidence of significant cardiac, renal or hepatic disease within previous 6 months.
•Significant central nervous system diseases within the last 6 months, i.e., stroke, spinal cord injury, multiple sclerosis, etc

发起方

eading Edge MarketingPO Box CR-56766, Suite 1210Nassau Bahamas