At a glance
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Use of Estriol at Distal Third of the Vaginal Wall Relieving Coital Pain in Women After Menopause: a Randomized, Blinded and Controlled Trial
In Brief
A Phase 1 clinical trial evaluating Estriol, Distal estriol, and 1 other intervention for Dyspareunia and 2 related conditions. Completed, enrolled 125 participants across 1 site.
Detailed Summary
Hypoestrogenism leads to vaginal wall changes resulting in diminished vaginal lubrication and, consequently, causing pain during intercourse. Topical estrogen therapy (THT) may control this complaint. However, there are limitations on its use, especially in patients with breast cancer and diagnosed endometrial cancer. This randomized clinical trial aims to assess the impact of local estriol therapy in postmenopausal women complaining of coital pain and to assess serum concentrations of estriol in these women after estriol use. One-hundred-thirty-two women aged between 40 and 65 years will be randomized into three groups: Women using estriol 1 mg / 1g at the proximal third of vagina every other night - estriol proximal group (PEG), women in using estriol 1 mg / 1g at the distal third of the vagina every other night - estriol distal group (DEG), gel group (GG) using water-based during intercourse.
Study Details
Timeline
Interventions
Women using drug 1 mg / 1g in the proximal third of the vagina every other night for 12 weeks
Women using drug 1 mg / 1g at the distal third of the vagina every other night for 12 weeks
Women using a base water gel lubricant during intercourse