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

2 1 1

What is this study about?

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.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Mbal Za Zhensko Zdrave Nadezhda OOD	Sofia	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Not yet recruiting	02.03.2026

Trial locations

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.

Investigated diseases:

Adenomyosis

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.

Trial ID:

2025-523076-23-00

Protocol code:

CHP23001

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?