Vulvovaginal dryness 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 clinical trial is investigating how vaginal estrogen treatment affects blood clotting in postmenopausal women experiencing vaginal atrophy. The study focuses on understanding whether local hormone therapy influences the body's natural balance between blood clotting and clot breakdown, which is important for assessing the overall safety of this treatment approach.

Main inclusion criteria:

• Postmenopausal women aged 50 or older who have not had menstrual periods for at least 12 months
• Experiencing symptoms of vulvovaginal atrophy, such as dryness, irritation, or discomfort in the vaginal area
• Having a medical need for standard vaginal estrogen treatment (10 micrograms 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, including children, pregnant women, or those unable to make decisions for themselves

Focus and goal of the trial:

The primary goal of this study is to evaluate how vaginal estrogen therapy affects the hemostatic balance, which refers to the body's system for controlling blood clotting and breakdown. Researchers will monitor participants over a three-month period to observe any changes in blood parameters related to clotting processes. The trial will compare effects in women with and without a history of blood clots in the veins, providing valuable safety information about this commonly prescribed treatment for vaginal dryness and discomfort after menopause.

Participants will undergo an initial assessment to confirm eligibility, followed by regular treatment administration and monitoring throughout the three-month study period. A final assessment will compare blood parameters before and after treatment to determine the therapy's effects on clotting mechanisms.

Investigational treatment:

The trial uses vaginal estrogen containing a combination of nomegestrol acetate and estradiol hemihydrate. This hormone therapy is applied directly to the vaginal area at a dose of 10 micrograms, at least three times per week. Estrogen works by binding to receptors in vaginal tissue, promoting growth and maintenance of the vaginal lining, which helps relieve symptoms such as dryness, itching, and discomfort during intercourse. The treatment is classified as hormone replacement therapy and is already used in standard medical practice for managing vaginal atrophy in postmenopausal women.

Summary

The single ongoing clinical trial for vulvovaginal dryness is being conducted in Denmark and focuses specifically on the safety aspects of vaginal estrogen therapy. The study examines an important question about how this widely used treatment affects blood clotting mechanisms in postmenopausal women. By including both women with and without a history of blood clots, the trial aims to provide comprehensive safety data that could help healthcare providers make more informed treatment decisions. The focus on local vaginal estrogen therapy reflects current standard care practices, while the investigation into hemostatic effects addresses an important safety consideration for hormone-based treatments.