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Study on the Effects of Vaginal Estrogen Treatment with Nomegestrol Acetate and Estradiol Hemihydrate on Blood Clotting in Postmenopausal Women with Vaginal Atrophy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for vaginal atrophy, a condition that often affects postmenopausal women. The treatment being tested involves the use of local vaginal estrogen, specifically a combination of two substances: nomegestrol acetate and estradiol hemihydrate. These substances are chemically similar to the hormones naturally found in the body and are used to help alleviate symptoms associated with vaginal atrophy.

The purpose of the study is to understand how this treatment affects the balance of blood clotting and breakdown in the body, known as the hemostatic balance. This is important because changes in this balance can affect the risk of blood clots. The study will involve postmenopausal women who will receive the treatment for a period of three months. During this time, researchers will monitor changes in blood clotting and breakdown processes to see if the treatment has any significant effects.

Participants in the study will receive the treatment at least three times a week. The study aims to compare the effects of the treatment on women with and without a history of venous thromboembolism (VTE), which is a condition where blood clots form in the veins. By the end of the study, researchers hope to gather valuable information on how local vaginal estrogen treatment influences blood clotting and breakdown in postmenopausal women.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participants will be informed about the purpose and procedures involved. The study aims to assess the effects of local vaginal estrogen treatment on certain blood parameters in postmenopausal women.
Step 2
Initial assessment
Participants will undergo an initial assessment to confirm eligibility. This includes confirming that participants are postmenopausal women aged 50 or older, experiencing symptoms of vaginal atrophy, and have an indication for standard treatment with vaginal estrogen.
Step 3
Treatment administration
Participants will receive a treatment of vaginal estrogen. The dosage is 10 micrograms, administered at least three times a week. This treatment is applied locally, meaning it is used directly in the vaginal area.
Step 4
Monitoring and follow-up
Throughout the study, participants will be monitored to observe any changes in blood parameters related to clotting and breakdown of clots. This monitoring will occur over a period of three months.
Step 5
Final assessment
At the end of the three-month period, a final assessment will be conducted to compare changes in blood parameters. This will help determine the effects of the treatment.

Who can join the trial?

4 criteria

Must be a postmenopausal woman aged 50 or older. Postmenopausal means you have stopped having menstrual periods for at least 12 months.
Must have symptoms of vulva vaginal atrophy. This means experiencing dryness, irritation, or discomfort in the vaginal area.
Must have a need for standard treatment with vaginal estrogen 10 micrograms at least three times a week. Estrogen is a hormone used to relieve symptoms of vaginal atrophy.
Can participate whether or not you have had a previous VTE (Venous Thromboembolism). VTE is a condition where blood clots form in the veins.

Who cannot join the trial?

3 criteria

Patients who are not postmenopausal women cannot participate.
Men cannot participate in the study.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or people who cannot make decisions for themselves.

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Aarhus University Hospital
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Aarhus, Denmark

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Investigated drugs

Vaginal Estrogen is a type of hormone therapy used in this clinical trial. It is applied directly to the vaginal area to help manage symptoms that occur after menopause, such as dryness or discomfort. In this study, the focus is on understanding how this treatment affects blood clotting and the breakdown of clots in postmenopausal women. The researchers are interested in seeing if using vaginal estrogen can change the balance of these processes in the body, which are important for maintaining healthy blood flow and preventing excessive bleeding or clotting.

What is already known about the treatment

Local Vaginal Estrogen – This medication is administered directly to the vaginal area in the form of a cream, tablet, or ring. It is currently used in medicine to treat vaginal atrophy, a condition common in postmenopausal women where the vaginal walls become thin, dry, and inflamed. The main therapeutic indication is to relieve symptoms such as dryness, itching, and discomfort during intercourse. At the molecular level, estrogen works by binding to estrogen receptors in the vaginal tissue, promoting the growth and maintenance of the vaginal lining. It is classified pharmacologically as a hormone replacement therapy.

Investigated diseases

Vaginal Atrophy – Vaginal atrophy, also known as atrophic vaginitis, is a condition characterized by the thinning, drying, and inflammation of the vaginal walls. It occurs most commonly in postmenopausal women due to decreased estrogen levels. The condition can lead to symptoms such as vaginal dryness, itching, and discomfort during intercourse. Over time, the lack of estrogen causes the vaginal tissues to become more fragile and less elastic. This can result in increased susceptibility to irritation and infection. The progression of vaginal atrophy can vary, with symptoms potentially worsening if not addressed.