Ongoing Clinical Trials for Vulvovaginal Discomfort
There is currently 1 ongoing clinical trial investigating treatment options for vulvovaginal discomfort in postmenopausal women. The trial focuses on understanding how local vaginal estrogen treatment affects blood clotting processes while relieving symptoms of vaginal atrophy.
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 clinical trial is being conducted in Denmark and aims to better understand how vaginal estrogen treatment affects blood clotting in postmenopausal women experiencing vaginal discomfort and dryness.
Main inclusion criteria:
- Postmenopausal women aged 50 or older who have not had menstrual periods for at least 12 months
- Experiencing symptoms such as vaginal dryness, irritation, or discomfort
- Have a medical need for treatment with vaginal estrogen at a dose of 10 micrograms, applied at least three times per week
- Women with or without a history of venous thromboembolism (blood clots in the veins) may participate
Main exclusion criteria:
- Women who are not postmenopausal
- Men
- Individuals who belong to vulnerable populations, such as those unable to make their own medical decisions
Focus and goal of the trial:
The study focuses on understanding how local vaginal estrogen treatment influences the body’s blood clotting and clot breakdown processes, known as hemostatic balance. This is particularly important because changes in this balance can affect the risk of developing blood clots. The trial will monitor postmenopausal women over a three-month treatment period to observe any significant effects on blood clotting parameters. Researchers are especially interested in comparing these effects between women with and without a previous history of blood clots in the veins.
The treatment involves applying vaginal estrogen directly to the vaginal area at least three times weekly. Throughout the study, participants will undergo monitoring to track changes in their blood parameters related to clotting processes. A final assessment at the end of the three-month period will help determine the treatment’s overall effects.
Investigational drug:
The treatment being tested uses vaginal estrogen, specifically a combination of nomegestrol acetate and estradiol hemihydrate. These substances are chemically similar to hormones naturally found in the body. The estrogen is applied locally to the vaginal area in the form of a cream, tablet, or ring. It works by binding to estrogen receptors in vaginal tissue, which helps promote the growth and maintenance of the vaginal lining. This hormone replacement therapy is designed to relieve symptoms such as dryness, itching, and discomfort while the study examines its effects on blood clotting processes.
Summary
Currently, there is one active clinical trial addressing vulvovaginal discomfort in postmenopausal women. The study is being conducted in Denmark and takes a unique approach by examining not only the symptom-relieving effects of vaginal estrogen treatment but also its impact on blood clotting mechanisms. This research is particularly relevant for understanding the safety profile of local estrogen therapy in women who may have different levels of risk for blood clot formation. The trial specifically includes both women with and without a history of venous thromboembolism, allowing researchers to gather comprehensive safety data across different patient profiles.
