Ongoing Clinical Trials for Stress Urinary Incontinence
Currently, there is 1 ongoing clinical trial investigating treatments related to stress urinary incontinence and associated conditions in postmenopausal women. This trial is being conducted in Denmark and focuses on vaginal estrogen treatment for women experiencing vaginal atrophy, a condition that can affect bladder function and contribute to urinary 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 clinical trial is investigating how vaginal estrogen treatment affects blood clotting in postmenopausal women who have vaginal atrophy. Vaginal atrophy is a condition where the vaginal walls become thin, dry, and inflamed due to reduced estrogen levels after menopause. This condition can cause discomfort, dryness, and irritation, and may also contribute to urinary symptoms.
Main inclusion criteria:
- Women aged 50 or older who are postmenopausal, meaning they 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 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) can participate
Main exclusion criteria:
- Patients who are not postmenopausal women
- Men
- People who are part of vulnerable populations, such as children, pregnant women, or individuals who cannot make decisions for themselves
Focus and goal of the trial:
The study aims to understand how local vaginal estrogen treatment influences the body’s blood clotting and clot breakdown processes, known as hemostatic balance. This is important because changes in this balance can affect the risk of developing blood clots. Participants will receive the vaginal estrogen treatment for three months, during which researchers will monitor changes in blood parameters. The trial will compare effects in women with and without a previous history of blood clots in the veins.
Throughout the study, participants will undergo an initial assessment to confirm eligibility, followed by treatment administration. They will be monitored over the three-month period, with a final assessment at the end to evaluate any changes in blood clotting parameters.
Investigational drug:
The treatment being tested is vaginal estrogen, specifically a combination of nomegestrol acetate and estradiol hemihydrate. These substances are chemically similar to hormones naturally found in the body. The medication is applied directly to the vaginal area in the form of a cream, tablet, or ring. At the molecular level, estrogen works by binding to estrogen receptors in vaginal tissue, helping to promote growth and maintenance of the vaginal lining. This hormone replacement therapy is designed to relieve symptoms such as dryness, itching, and discomfort.
Summary
Currently, there is one active clinical trial related to conditions affecting postmenopausal women that may impact urinary and vaginal health. This trial is being conducted in Denmark and focuses specifically on understanding the safety profile of vaginal estrogen treatment, particularly its effects on blood clotting mechanisms. The study targets women with vaginal atrophy who require hormone therapy, and includes both women with and without a history of blood clots. The investigational approach uses locally applied estrogen, which represents a standard treatment option being evaluated for its broader physiological effects beyond symptom relief.