Adenomyosis
Conditions
Brief summary
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)
Detailed description
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
DRUGМИГ-400 400 mg филмирани таблетки
DRUGНАТРИЕВ ХЛОРИД СОФАРМА 9 mg/ml инжекционен разтвор
DRUGKонвулекс хроно 500 mg таблетки с удължено освобождаване
DRUGКонвулекс 100 mg/ml инжекционен разтвор/инфузионен разтвор
DRUGComparator 2: hard gelatine capsules (no active compounds)
Sponsors
CCDRD Cooperative Clinical Drug Research and Development AG, Nadezhda Reproductive Science OOD
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Outcome results
None listed