Study identification

EU PAS number

EUPAS5783

Study ID

22392

Official title and acronym

Post-authorization surveillance study comparing the efficacy and safety of Medabon (mifepristone/misoprostol) to historical data for early pregnancy termination (Medabon PASS)

DARWIN EU® study

No

Study countries

Sweden
United Kingdom

Study description

This is an open-label, non-interventional, prospective, observational, post-authorization study of the outcomes and safety associated with the use of Medabon for the medical termination of developing intra-uterine pregnancy of up to 63 days of amenorrhoea. This study is designed to obtain descriptive information on the safety and efficacy of Medabon in women undergoing termination of early pregnancy, and to evaluate and compare the emergency evacuation rate, continuing pregnancy rate and requirement for surgical intervention to the historical rates for this combination treatment. Subjects requesting medical abortion for which treatment with mifepristone/misoprostol is medically appropriate will be treated with Medabon per institutional practice and according to the European Summary of Product Characteristics, and followed for at least 14 days for treatment outcome, adverse events, and the requirement for other subsequent interventional treatment.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Juliette Omtzigt

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Sun Pharmaceutical Industries Europe B.V.
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)