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Clinical Trials in the EU / 2025-523076-23-00
Authorised, recruiting Phase II

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

2025-523076-23-00 · tracked via the Priya Life Science EU tracker
Sponsor
CCDRD Cooperative Clinical Drug Research and Development AG, Nadezhda Reproductive Science OOD
Sponsor type
Pharmaceutical company, Laboratory/Research/Testing facility
Therapeutic area
Female Urogenital Diseases and Pregnancy Complications
Decision date
03/04/2026
Enrollment target
60
Sites
Bulgaria

Condition studied

Adenomyosis

Investigational medicinal product(s)

МИГ-400 400 mg филмирани таблеткиНАТРИЕВ ХЛОРИД СОФАРМА 9 mg/ml инжекционен разтворKонвулекс хроно 500 mg таблетки с удължено освобождаванеКонвулекс 100 mg/ml инжекционен разтвор/инфузионен разтворComparator 2: hard gelatine capsules (no active compounds)

Eligibility

Age group
18-64 years
Sex
Female

Primary endpoint

Pre−post absolute change between baseline and final value after 29 days treatment in AAPP, Final value at the end of 29 days of treatment in the amount of analgesic rescue medication taken (ibuprofen 400 mg tablets)

Endpoint detail

Pre−post absolute change of each pain type associated with adenomyosis (non-menstrual pelvic pain, dysmenorrhea, dyspareunia) as documented on a VAS (in units) at each visit, Clinical Global Impressions (CGI) scale after EoT on Day 30 (+4 days) visit), Patient Global Impression of Change (PGIC) scale after EoT on Day 30 (+4 days) visit), Pre−post absolute change in the lesion(s) size after EoT on Day 30 (+4 days) visit), Pregnancy rate after the first in vitro fertilization cycle performed after a wash-out period of at least 30 days after the end of treatment

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-523076-23-00 on CTIS ↗ ← All trials in the EU