Vulvovaginal pain Trials in Disease

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 investigating how vaginal estrogen treatment affects blood clotting processes in postmenopausal women suffering from vaginal atrophy. The study focuses on understanding the safety profile of this treatment, particularly regarding blood clot formation, which is an important consideration for hormone-based therapies.

Main inclusion criteria:

• Postmenopausal women aged 50 or older who have not had menstrual periods for at least 12 months
• Experiencing symptoms of vaginal atrophy, such as dryness, irritation, or discomfort in the vaginal area
• Have a medical need for standard treatment with vaginal estrogen (10 micrograms at least three times weekly)
• Women both with and without a previous history of venous thromboembolism (blood clots in the veins) can participate

Main exclusion criteria:

• Women who are not postmenopausal
• Men
• Individuals who are part of vulnerable populations, including children, pregnant women, or those unable to make decisions for themselves

Focus and goal:

The primary goal of this three-month study is to evaluate how local vaginal estrogen treatment influences the balance between blood clotting and clot breakdown in the body, known as hemostatic balance. Researchers will monitor participants throughout the treatment period to observe any changes in blood parameters related to clotting. The study aims to compare these effects in women with and without a history of venous thromboembolism. This information is valuable because changes in blood clotting balance can affect the risk of developing blood clots, which is an important safety consideration for hormone therapies.

Investigational treatment:

The study uses vaginal estrogen containing nomegestrol acetate and estradiol hemihydrate. These substances are chemically similar to hormones naturally found in the body. The treatment is applied directly to the vaginal area at a dosage of 10 micrograms, at least three times per week. The estrogen works by binding to estrogen receptors in the vaginal tissue, helping to restore and maintain the vaginal lining, which can relieve symptoms such as dryness, itching, and discomfort.

Summary

Currently, only one clinical trial is recruiting participants for vulvovaginal pain related to vaginal atrophy. This trial is being conducted in Denmark and focuses specifically on postmenopausal women. The study represents an important safety investigation into vaginal estrogen therapy, examining its effects on blood clotting mechanisms rather than just symptom relief. This approach reflects growing attention to understanding the full safety profile of hormone-based treatments in postmenopausal women. Women interested in participating should be experiencing symptoms of vaginal atrophy and have an indication for vaginal estrogen treatment. The trial welcomes both women with and without a history of blood clotting disorders, allowing researchers to compare outcomes across different patient groups.