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A study to evaluate the effect of valproic acid in women of reproductive age with adenomyosis

Registered drugNo placebo

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What is this trial about?

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

This study focuses on Adenomyosis, a condition where the tissue that normally lines the uterus grows into the muscular wall of the uterus. This condition can cause pelvic pain and heavy periods. The purpose of the study is to evaluate the effect of valproic acid in women with this condition.

Participants may receive valproic acid through an intralesional administration, which means the medicine is injected directly into the affected area, followed by taking valproic acid as an oral medication. Other participants might receive sodium chloride through an injection into the affected area, followed by a placebo taken orally. Some individuals may also use ibuprofen as a rescue medication to help manage pain during the study period.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial administration
A single intralesional administration, which is an injection directly into the affected area, is performed. this involves either sodium valproate at a dose of 40 mg/ml or sodium chloride, which is a salt solution, at a dose of 8 ml.
Step 2
Oral medication phase
Following the injection, oral medication is taken for a period of 29 days.
The medication consists of either sodium valproate in the form of 500 mg prolonged-release tablets or a placebo, which are hard gelatine capsules containing no active substances.
Step 3
Rescue medication use
During the treatment period, ibuprofen tablets of 400 mg may be taken as rescue medication to manage pain.
Step 4
Final assessment
A follow-up visit occurs on day 30, which is 4 days after the completion of the 29-day treatment period.
During this visit, assessments are made regarding pelvic pain, lesion size (the size of the affected area), and overall clinical impressions.

Who can join the trial?

12 criteria

Women who have not yet reached menopause (the period when periods stop permanently) and are between 18 and 45 years old.
Women who agree to use only ibuprofen, which is a common pain reliever, as a rescue medication (extra medicine taken to manage pain that is not controlled by the study treatment), with a limit of 2400 mg per day.
Women who are physically and mentally able to participate and who provide written informed consent (a signed document stating they understand and agree to join the study).
Women who agree to avoid sexual intercourse during the screening, treatment, and wash-out period (the time when the study medicine is cleared from the body) unless they have had permanent procedures like surgical sterilization or bilateral tubal occlusion (a procedure to block the fallopian tubes to prevent pregnancy).
Women with adenomyosis (a condition where the lining of the uterus grows into the muscle wall of the uterus) who experience pelvic pain (pain in the lower abdomen area) rated at 4 or higher on a Visual Analogue Scale (a simple tool used to measure pain intensity where patients mark their pain level on a line).
Women who have experienced this pelvic pain for at least the last 6 months.
Women who have had their condition confirmed by an MRI (a medical imaging test using magnets), a transvaginal ultrasound (an imaging test using a probe inserted into the vagina), or a hysteroscopy (a procedure where a doctor looks inside the uterus with a small camera) within the last 5 years.
Women who show one or more clear areas of adenomyosis during a transvaginal ultrasound.
Women whose adenomyotic lesions (areas of diseased tissue) are suitable for treatment and do not exceed a specific total dose of the study medication.
Women who have a history of difficulty getting pregnant or have had more than one spontaneous abortion (a natural miscarriage).
Women who wish to become pregnant, either through in-vitro fertilization (a medical procedure to help with pregnancy) or naturally, after the study and the wash-out period are finished.
Women who have regular menstrual cycles lasting between 21 and 35 days and are not taking any medicines, such as oral contraceptive pills (birth control pills), that change their period.

Who cannot join the trial?

29 criteria

A history of being allergic or having a bad reaction to the study medicine, any of its ingredients (the substances used to make the medicine), or the rescue medication (medicine used to treat symptoms if the study drug does not work).
Having myomas, which are non-cancerous growths in the uterus, that are larger than 3 cm when seen on an ultrasound or MRI (special imaging tests).
Having abnormal results from a cervical smear (a test that checks the health of the cervix), specifically those classified as class III or higher in the Papanicolaou system, class IIp or higher in the Munich III system, or ASC-US or higher in the Bethesda system.
Having had surgery to treat adenomyosis (a condition where the lining of the uterus grows into the muscle wall of the uterus) within the last 3 months.
Having chronic pelvic pain (long-term pain in the lower abdomen) that is not caused by adenomyosis.
Having hepatitis, which is an inflammation of the liver, either occurring suddenly (acute) or lasting for a long time (chronic).
Having hepatic insufficiency, which means the liver is not working properly.
A family history of severe hepatitis, particularly when caused by drugs.
Having hepatic porphyria, a group of rare disorders that affect the production of certain substances needed by the body.
Having any abnormal clinical or laboratory findings that the doctor believes are important for your health.
Testing positive for HBs-Ag (a marker for Hepatitis B), anti-HCV (a marker for Hepatitis C), or HIV-1/HIV-2 antibodies (markers for the virus that causes AIDS).
Using an intrauterine device (IUD); this device must be removed before joining the study.
Using antipsychotics (medicines for mental health conditions) or analgesics (pain relievers) other than ibuprofen during the screening period. This includes opioids (strong pain medicines), NSAIDs (non-steroidal anti-inflammatory drugs), paracetamol, or metamizole, except for very short-term use for certain urgent needs.
A history of using illegal drugs or alcohol abuse within the last 6 months.
Participating in another clinical trial within the last 3 months.
Having already participated in this specific study before.
Having any condition that the doctor believes might make it difficult to follow the study procedures or assessments (the tests and rules of the study).
Being unable to cooperate or being unreliable during the screening period.
Being unwilling or unable to properly fill out the study diary (a written record of symptoms and activities).
Being a relative or dependent of the lead doctor or the company sponsoring the study, or being an employee at the study site.
Having a legal incapacity or any other situation that prevents you from understanding what the study involves and its possible effects.
Being in custody or under the control of a judicial order.
Having thoughts of suicide during the screening or at the start of the study.
Having known reasons why valproic acid cannot be used, such as epilepsy (seizure disorder), systemic lupus erythematosus (an autoimmune disease), urea cycle enzyme deficiencies (problems processing proteins), impaired kidney function, carnitine deficiency, or mitochondrial disorders (problems with the energy-producing parts of cells).
Being pregnant, breast-feeding, planning to become pregnant, or having recently given birth, had an abortion, or stopped breastfeeding within a specific timeframe.
Using certain hormonal agents (medicines that affect hormones) within a specific timeframe before the study begins.
A history of any type of cancer, including breast cancer.
Having other significant gynecological conditions (problems related to the female reproductive system), such as uterine fibroids (growths in the uterus) that need treatment.
Having an ovarian cyst (a fluid-filled sac on the ovary) of unknown cause.

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Investigated drugs

Sodium valproate
is the medication being tested in this study. In this trial, it is used in two ways: first, it is injected directly into the affected area, and then it is taken by mouth as a pill. The goal is to see if this treatment helps reduce pelvic pain caused by adenomyosis.
Ibuprofen
is used as a background medication. This is a common medicine used to help reduce pain and inflammation.

What is already known about the treatment

Ibuprofen
This medication is taken as a pill that you swallow. It is a well-known medicine used to reduce pain and inflammation in various conditions. It works by blocking specific enzymes in the body that produce chemicals responsible for causing pain and swelling. This drug belongs to a group of medicines known as non-steroidal anti-inflammatory drugs.
Sodium chloride
This is a salt solution that is administered through an injection directly into a specific area of the body. It is widely used in medical practice as a basic liquid for various treatments and to maintain fluid balance. In this context, it acts as a simple saline solution to compare against the active test substance. It is classified as an electrolyte or a medicinal salt.
Valproic acid
This medication is available as a pill that is swallowed or as a liquid that is injected directly into a specific area. It is an established medicine used primarily to control seizures and manage certain mood disorders. At a molecular level, it works by increasing the levels of a calming chemical in the brain to reduce nerve activity. It belongs to a category of drugs known as anticonvulsants.

Investigated diseases

Adenomyosis - This condition occurs when the tissue that normally lines the uterus begins to grow into the muscular wall of the uterus. As the disease progresses, this misplaced tissue can cause the uterine wall to thicken. This process often leads to various types of pelvic discomfort. The symptoms can include pain during menstrual periods and pain during sexual intercourse. The condition may also result in non-menstrual pelvic pain.

Adenomyosis

Trial detailsLast updated 2 Oct 2026

Age: 18+ years
Phase: Phase II
Trial ID i: 2025-523076-23-00
Protocol code: CHP23001
Estimated enrolment: 60 patients
Sponsor: CCDRD Cooperative Clinical Drug Research and Development AG

Want to learn more about this trial or check if you can participate?

Trial detailsLast updated 2 Oct 2026

Age18+ yearsPhasePhase IITrial ID2025-523076-23-00Protocol codeCHP23001Estimated enrolment60 patientsSponsorCCDRD Cooperative Clinical Drug Research and Development AG

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

A study to evaluate the effect of valproic acid in women of reproductive age with adenomyosis

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What is this trial about?

schedule The research process

Initial administration

Oral medication phase

Rescue medication use

Final assessment

Who can join the trial?

Who cannot join the trial?

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Trial locations

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medication Investigated drugs

What is already known about the treatment

Ibuprofen

Sodium chloride

Valproic acid

stethoscope Investigated diseases

Ongoing clinical trials in Adenomyosis

Endometriosis+1

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The research process

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Investigated drugs

Investigated diseases