Study identification

EU PAS number

EUPAS11131

Study ID

47862

Official title and acronym

A Post-Marketing Observational Study of Implanon® Radiopaque among Chinese Women Aged 18 and Older Requesting Contraception (MK-8415-038)

DARWIN EU® study

No

Study countries

China

Study description

This is a post-marketing observational study intended to evaluate participant and physician satisfaction, serious adverse events (SAEs), drug related adverse events (AEs) including topical AEs as well as overall contraceptive effectiveness in routine clinical practice. The primary objective is to evaluate the overall safety profile of Implanon® Radiopaque.

Study status

Finalised
Research institutions and networks

Institutions

Merck Sharp & Dohme LLC
United States
First published:
08/07/2025
Institution Pharmaceutical company
Merck Sharp & Dohme (China) Ltd. Level 7,Tower E3, The Towers, Oriental, Beijing,100738 China

Contact details

Clinical Trials Disclosure Merck Sharp & Dohme Corp.

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:

Date of final study report

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

More details on funding

Merck Sharp & Dohme Corp.
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable