Authorised Therapeutic exploratory (Phase II) Adenomyosis

Treatment of adenomyosis in women of reproductive age.

EU CTIS ID: 2025-523076-23-00

What this study is testing

To evaluate the effect of valproic acid after a single intralesional administration of valproic acid followed by oral dosing of valproic acid as compared to placebo or a single intralesional administration of valproic acid followed by placebo oral dosing, for the treatment of adenomyosis in reproductive-age women, as measured by the overall effect on pelvic pain documented on a Visual Analog Scale (VAS) and considering the intake of rescue medication.

Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

[1] Premenopausal female, between 18 and 45 years of age inclusive, at the time of signing consent
[10] Patients who agree to use only ibuprofen 400 mg as rescue medication up to a total daily dose of not more than 2400 mg
[11] Patients willing and able (e.g. mental and physical condition) to participate in all aspects of the study as evidenced by providing signed written informed consent according to chapter 5.3 of clinical trial protocol
[12] Patient agrees to sexual abstinence during the entire duration of the screening, treatment and for the wash-out period of the study. Does not apply if the patient can confirm either of the following: • surgical sterilization or bilateral tubal occlusion.
[2] Patients with Adenomyosis - Associated Pelvic Pain (AAPP: i.e., any type of pelvic pain associated with adenomyosis: non-menstrual pelvic pain, dysmenorrhea and/or dyspareunia) as measured by Visual Analogue Scale (VAS) ≥ 40 units (as defined in chapter 9.3.1) at least once during screening period
[3] Patients with a history of AAPP for at least the past 6 months prior to the initial screening period

You likely can't join if

[1] History of hypersensitivity or intolerance to the active substance or any of the excipients of the study and rescue medication
[10] Visible myomas > 3 cm on ultrasound/MRI
[11] Cervical smear with pathological findings: class III or higher according to Papanicolaou, class IIp or higher according to the Munich III nomenclature or ASC-US or higher according to the Bethesda system
[12] Surgical treatment of adenomyosis within 3 months prior to the screening period
[13] Presence of chronic pelvic pain other than pain due to adenomyosis
[14] Acute or chronic hepatitis

See the full eligibility criteria

Who can join

[1] Premenopausal female, between 18 and 45 years of age inclusive, at the time of signing consent
[10] Patients who agree to use only ibuprofen 400 mg as rescue medication up to a total daily dose of not more than 2400 mg
[11] Patients willing and able (e.g. mental and physical condition) to participate in all aspects of the study as evidenced by providing signed written informed consent according to chapter 5.3 of clinical trial protocol
[12] Patient agrees to sexual abstinence during the entire duration of the screening, treatment and for the wash-out period of the study. Does not apply if the patient can confirm either of the following: • surgical sterilization or bilateral tubal occlusion.
[2] Patients with Adenomyosis - Associated Pelvic Pain (AAPP: i.e., any type of pelvic pain associated with adenomyosis: non-menstrual pelvic pain, dysmenorrhea and/or dyspareunia) as measured by Visual Analogue Scale (VAS) ≥ 40 units (as defined in chapter 9.3.1) at least once during screening period
[3] Patients with a history of AAPP for at least the past 6 months prior to the initial screening period
[4] Adenomyosis diagnosed by MRI or transvaginal ultrasound, or by means of hysteroscopy in the past 5 years
[5] Patients with one or more distinctive adenomyotic lesions, confirmed by transvaginal ultrasonography (TVUS) at screening
[6] Presence of one or more lesions suitable for treatment with Convulex, with the total dose not exceeding 40 mg (equivalent to 8 mL of the final solution at 5 mg/mL concentration), as identified under ultrasound guidance
[7] Patients with history of infertility and/or more than one spontaneous abortion
[8] Patients seeking to achieve pregnancy either through in-vitro fertilization (IVF) (optional) or spontaneous conception after the end of treatment with study medication and the wash-out period
[9] Patients with a history of regular menstrual cycles (21-35 days) while not being on any pharmacological treatment that could alter the menstrual cycle (e.g. oral contraceptive pills)

What rules you out

[1] History of hypersensitivity or intolerance to the active substance or any of the excipients of the study and rescue medication
[10] Visible myomas > 3 cm on ultrasound/MRI
[11] Cervical smear with pathological findings: class III or higher according to Papanicolaou, class IIp or higher according to the Munich III nomenclature or ASC-US or higher according to the Bethesda system
[12] Surgical treatment of adenomyosis within 3 months prior to the screening period
[13] Presence of chronic pelvic pain other than pain due to adenomyosis
[14] Acute or chronic hepatitis
[15] Hepatic insufficiency
[16] Family history of severe hepatitis, especially drug related
[17] Known hepatic porphyria
[18] Abnormal clinical and/or laboratory findings considered by the investigator as clinically relevant
[19] Positive results for HBs-Ag, anti-HCV and HIV-1/HIV-2-antibodies
[2] Presence of an intrauterine device (IUD); participants with IUDs must have them removed prior to enrollment
[20] The use of antipsychotics or analgesics other than ibuprofen—including opioids, NSAIDs, paracetamol, or metamizole—is prohibited during the screening period. Short-term use (up to 3 days) of NSAIDs (other than ibuprofen) or metamizole is allowed for acute conditions (e.g., flu-like symptoms, emergency dental procedures or other acute conditions). The use of Fentanyl, Propofol, and Metoclopramide is also permitted only as short-term venous anaesthesia for the intralesional application of the study drug
[21] History of illicit drug or alcohol abuse within 6 months prior to screening visit
[22] Participation in another trial within 3 months before the screening period
[23] Previous enrolment in this study
[24] Any condition that, in the judgment of the investigator, may interfere with adherence to study procedures or study assessments
[25] Unreliability or lack of cooperation during the screening period
[26] Unwillingness or inability to complete the (paper) DIARY properly during the screening period
[27] Relatives and dependents of the PI/Sponsor; study site employees directly subordinate to the PI or sub-investigators
[28] Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study
[29] Patients who are known or suspected to be in custody or submitted to an institution due to a judicial order.
[3] Positive suicidal ideation at screening or Day 0
[4] Known contraindications to the use of valproic acid (VPA), as specified in the SmPC, including epilepsy, systemic lupus erythematosus (SLE), hereditary enzyme deficiencies affecting the urea cycle, impaired kidney function, uncorrected systemic primary carnitine deficiency, or mitochondrial disorders caused by mutations in the nuclear gene encoding the mitochondrial enzyme polymerase γ (POLG), such as Alpers-Huttenlocher Syndrome
[5] Subject is pregnant or breast-feeding or is planning a pregnancy within the duration of the screening, treatment, and wash-out periods of the study or is less than 6 months postpartum or post-lactation or less than 1-month post-abortion, at the time of entry into the screening period
[6] Previous or concomitant use of hormonal agents before the screening period: ≤ 24 weeks for GnRH agonists and hormonal implants (or longer, depending on the specific implant type); ≤ 12 weeks for depot progestogens and danazol; ≤ 6 weeks for oral and vaginal contraceptives
[7] Patients with history of any type of cancer (including breast cancer)
[8] Other clinically significant gynaecological condition already known or identified during the screening period such as symptomatic uterine fibroids requiring treatment
[9] Presence of ovarian cyst of unknown etiology

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.