Trials Sponsors Conditions Drugs Pricing

Conditions

Adenomyosis

Outcome Measures

Primary Outcomes (2)

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)

Secondary Outcomes (5)

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

Interventions

МИГ-400 400 mg филмирани таблеткиType not reported

НАТРИЕВ ХЛОРИД СОФАРМА 9 mg/ml инжекционен разтворType not reported

Kонвулекс хроно 500 mg таблетки с удължено освобождаване

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
МИГ-400 400 mg филмирани таблетки
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

МИГ-400 400 mg филмирани таблетки
Named ingredient: Ibuprofen
View registry record

Eligibility Criteria

Sexfemale

Age GroupsAdult (18-64)

You may qualify if:

[1] Premenopausal female, between 18 and 45 years of age inclusive, at the time of signing consent
[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

Sponsors & Collaborators

CCDRD Cooperative Clinical Drug Research and Development AG
Industrylead
Nadezhda Reproductive Science OOD
Type not reportedco_sponsor

Study Sites (1)

Mbal Za Zhensko Zdrave Nadezhda OOD

Sofia, 1330, Bulgaria

Georgi Stamenov+359884700704 georgistamenov@abv.bg

Central Study Contacts

Spas Petkov, Managing Director

+359887224426 Spas.Petkov@huvepharma.com

Spas Petkov, Managing Director

+359887224426

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

December 2, 2025

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2025-523076-23-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-29 08:43:39 UTC

Documents

2025-523076-23-00_CSP_Valproic_Acid_public

You may not qualify if:

[1] History of hypersensitivity or intolerance to the active substance or any of the excipients of the study and rescue medication
[2] Presence of an intrauterine device (IUD); participants with IUDs must have them removed prior to enrollment
[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
[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
+14 more criteria

Treatment of adenomyosis in women of reproductive age.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (5)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (5)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations