Ongoing Clinical Trials for Vaginal Haemorrhage
Currently, there is 1 ongoing clinical trial investigating treatments related to vaginal haemorrhage. This trial is focused on understanding how vaginal estrogen treatment affects blood clotting processes in postmenopausal women with vaginal atrophy, a condition that can be associated with vaginal bleeding symptoms.
Clinical trial locations
Study on the Effects of Vaginal Estrogen Treatment with Nomegestrol Acetate and Estradiol Hemihydrate on Blood Clotting in Postmenopausal Women with Vaginal Atrophy
This trial is being conducted in Denmark and focuses on understanding how local vaginal estrogen treatment affects blood clotting processes in postmenopausal women. The treatment being studied involves a combination of nomegestrol acetate and estradiol hemihydrate, two substances that are similar to hormones naturally found in the body.
Main inclusion criteria:
- You must be a postmenopausal woman aged 50 or older, meaning you have not had menstrual periods for at least 12 months
- You must be experiencing symptoms of vulva vaginal atrophy, such as dryness, irritation, or discomfort in the vaginal area
- You must have a medical need for standard treatment with vaginal estrogen (10 micrograms at least three times a week)
- You can participate whether or not you have had a previous venous thromboembolism, which is a condition where blood clots form in the veins
Main exclusion criteria:
- You cannot participate if you are not a postmenopausal woman
- Men cannot participate in the study
- Members of vulnerable populations, such as children, pregnant women, or people who cannot make decisions for themselves, cannot participate
Focus and goal of the trial: The main purpose of this study is to understand how vaginal estrogen treatment influences the balance between blood clotting and the breakdown of blood clots in the body. This balance is important because changes can affect the risk of developing blood clots. The researchers will monitor participants over a three-month period to observe any changes in blood parameters related to clotting. The study will compare effects in women with and without a history of blood clots in the veins.
Investigational drug: The treatment being tested is vaginal estrogen, applied directly to the vaginal area. It works by binding to estrogen receptors in the vaginal tissue, helping to restore and maintain the vaginal lining. In this trial, the specific formulation contains nomegestrol acetate and estradiol hemihydrate, and is administered at least three times a week at a dose of 10 micrograms.
Summary
Currently, only one clinical trial is investigating treatments related to vaginal haemorrhage, specifically in the context of postmenopausal vaginal atrophy. This trial is taking place in Denmark and focuses on understanding the relationship between local vaginal estrogen treatment and blood clotting processes. The study is particularly relevant for postmenopausal women who require vaginal estrogen therapy and aims to provide important safety information about how this treatment affects the body’s clotting mechanisms. Women with and without a history of blood clots can participate, which will help researchers better understand the treatment’s effects across different patient groups.