Clinical Trial: Vaginal Progesterone Versus Placebo for the Treatment of Vaginal Atrophy
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Vaginal Progesterone Versus Placebo for the Treatment of Vaginal Atrophy - a Double Blind Randomized Control Trial
Brief Summary:
Atrophic vaginitis affects the majority of post-menopausal women. It is characterized by dryness and inflammation of the vagina, with thinning of the vaginal tissues. Atrophic vaginitis is caused by the decreased effect of estrogens post menopause. Traditionally, local estrogens have been used to treat atrophic vaginitis
Studies have shown that there are progesterone receptors in vaginal tissues. The use of progesterone to treat atrophic vaginitis has not yet been studied. However, its use has been studied in other populations including as a fertility medication in pregnant women.
There is a significant group of women who cannot use, choose not to use, or do not respond to estrogenic therapies. The goal of this study is to evaluate the efficacy of vaginal progesterone in the treatment of urogenital atrophy, compared to placebo. This study is a randomized, double-blind, placebo controlled trial. The ultimate goal is to expand the treatment options for patients with symptoms of vaginal atrophy.
Detailed Summary:
Introduction
Atrophic vaginitis is a condition that affects the majority of postmenopausal women. It is characterized by dryness and inflammation of the vagina, with thinning of the vaginal tissues. Atrophic vaginitis is caused by the decreased effect of estrogens post menopause. This condition becomes more significant over time, as systemic levels of estrogen decline. This is in contrast to vasomotor symptoms of the peri-menopause and early post-menopause, which generally subside as time passes. Therefore, because of an aging demographic, it is a condition that will have an ever-growing population requiring its treatment. However, only a minority of women that suffer from atrophic vaginitis seek medical help. Instead, many women make difficult lifestyle changes to deal with their symptoms. This may include avoiding sexual activity to avoid the associated pain with intercourse.
The vagina has a significant of estrogen receptors. Effects of estrogens on the vagina have been well studied. Currently, there are numerous estrogenic therapy options, both systemic and local, to treat symptoms of vaginal atrophy. Recent evidence supports the efficacy of this population of lower vaginal estrogen doses (10mcg) than previously used (25mcg). Emerging evidence is demonstrating efficacy for ultra-low doses of estrogen therapies. The search for such low doses of estrogen therapy suggests an ongoing distrust among both the public and the scientific community for the acceptability of estrogen therapy. Despite these lower does, many women are still unable or unwilling to use local estrogen therapy. The options for such women are limited.
Studies have shown that there are progesterone receptors in vaginal tissues. The use of progesterone to treat atrophic vaginitis has not yet been studied. H
Sponsor: Mount Sinai Hospital, Canada
Current Primary Outcome: Improvement in the patient's perception of their most bothersome vulvovaginal symptom as described by a detailed rating scale (eg. dryness, dyspareunia) [ Time Frame: 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Change in physician-assigned vaginal health index score based on a detailed rating scale [ Time Frame: 12 weeks ]
Original Secondary Outcome: Same as current
Information By: Mount Sinai Hospital, Canada
Dates:
Date Received: May 29, 2015
Date Started: December 2016
Date Completion: December 2018
Last Updated: December 5, 2016
Last Verified: December 2016
