AuthorisedTherapeutic exploratory (Phase II)Interventional

Randomized, Double-blind, Placebo-controlled, Proof-of-concept Phase II Trial Investigating the Effect of Valproic Acid in Women with Adenomyosis.

This research study is investigating a new treatment for adenomyosis, a condition where the womb lining grows into the muscle wall. The study is particularly interested in a medication known as valproic acid. We want to find out if this medication can help reduce the pain and other symptoms that women with adenomyosis experience. The study involves giving some participants the active medication and others a placebo – a dummy drug that looks the same but has no active ingredients. This helps us compare the effects fairly. Participants will be treated for 29 days, and we'll be carefully checking how their pain levels change and if they need less pain medication during this time. The goal is to see if valproic acid could be a helpful new option for managing adenomyosis.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

CCDRD Cooperative Clinical Drug Research and Development AG, Nadezhda Reproductive Science OOD

Enrolment target

Start

03 Apr 2026

Adenomyosis

What is this study about?

This study is looking into a condition called adenomyosis. Adenomyosis is when the tissue that normally lines the womb starts to grow into the muscular wall of the womb itself. This can cause various problems, often leading to heavy periods, severe period pain, and pelvic pain that isn't related to periods. It can make everyday life very difficult for many women.

Currently, there are different ways to manage adenomyosis, but doctors are always looking for better and more effective treatments. This particular study is focusing on a medication called valproic acid. This drug is already used for other health conditions, but researchers want to see if it could also be helpful for women with adenomyosis, specifically to reduce their pain and improve their overall symptoms.

During the study, some women will receive valproic acid, while others will receive a placebo – a tablet that looks identical but contains no active medicine. This allows the researchers to fairly compare if the valproic acid is truly making a difference. The study will last for 29 days of treatment, and doctors will carefully track how participants' pain levels change, if they need less pain relief, and how they feel overall. These studies are important because they help doctors find new and better ways to help people living with conditions like adenomyosis.

Key takeaways

This study is testing a new medication (valproic acid) for adenomyosis.
It aims to see if the drug can reduce pain and improve symptoms.
Some participants will receive the active drug, others a dummy drug (placebo).
The treatment period is 29 days, with follow-up appointments.
Women aged 18 and over with adenomyosis can potentially join.
Close medical monitoring is provided throughout the study.

Who may be eligible?

This study is open to women aged 18 years and older who have been diagnosed with adenomyosis. There is no upper age limit, so as long as you are over 18, you might be able to take part.

The research team will need to check a few other things to make sure the study is right for you and that taking part would be safe. This includes looking at your general health and any other medications you might be taking. For example, if you are pregnant, planning to get pregnant soon, or breastfeeding, you would likely not be able to join this study.

If you're interested, the study doctors will go through a full list of criteria with you to see if you meet all the requirements. It's important that participants are a good fit for the study to ensure accurate results and your safety.

Quick self-check

I am a woman.
I am 18 years old or older.
I have been diagnosed with adenomyosis.
I am not pregnant or planning to become pregnant soon.
I am willing to follow the study schedule and visits.

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, here’s a general idea of what would be involved.

First, you would have a screening visit where doctors check if you are suitable for the study. If you are, you would then start the study treatment. You would receive either the study medication (valproic acid) or a placebo (a dummy drug), which you would take for 29 days.

During these 29 days, and for a short while after, you would have several visits to the clinic. At these visits, doctors and nurses would ask you about your pain levels and any other symptoms you are experiencing. They would also keep track of how much pain relief, like ibuprofen, you might be taking. You might also have some scans or checks to see if there are any changes in the adenomyosis itself. After the treatment period, there will be a follow-up visit to see how you are doing. The total duration of your active participation, including follow-up, would last around a month, plus a potential follow-up if you decide to try for pregnancy after the study.

Potential risks and benefits

Taking part in a clinical trial could offer some potential benefits. You might receive a new treatment for adenomyosis that is not yet widely available, and you'll receive close medical attention and monitoring throughout the study. However, there's no guarantee that the treatment will work for you or improve your symptoms. There are also potential risks involved; the study medication, like all medicines, can have side effects, which the research team will explain fully. The placebo group won't receive the active drug, so their symptoms may not improve. You are free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

—
Bulgaria

Common questions

What is adenomyosis?

Adenomyosis is a condition where the tissue that normally lines the womb starts to grow into the muscular wall of the womb. This can cause severe period pain, heavy bleeding, and pelvic pain.

What is valproic acid?

Valproic acid is a medication that's currently used for other health conditions. Researchers are studying if it could also help reduce pain and symptoms in women with adenomyosis.

What is a 'placebo'?

A placebo is a 'dummy' tablet that looks just like the real medicine but contains no active drug. It helps researchers compare if the real medicine is actually working.

How long will I be taking part in the study?

The treatment part of the study involves taking medication for 29 days. There will be clinic visits during and after this period, and the total active part will be about a month.

Can I get pregnant during the study?

If you are planning to get pregnant or are pregnant, you would most likely not be able to join this study. The study also tracks pregnancy rates after treatment in some women.