Post-marketing Observational Study to Characterize the Safety and Effectiveness Profile of Orgalutran® in Chinese Women Undergoing Controlled Ovarian Hyperstimulation for Assisted Reproduction Techniques (MK-8761-050)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/22133
• EU PAS number:
  EUPAS8737
• Study ID:
  22133
• Official title and acronym:
  Post-marketing Observational Study to Characterize the Safety and Effectiveness Profile of Orgalutran® in Chinese Women Undergoing Controlled Ovarian Hyperstimulation for Assisted Reproduction Techniques (MK-8761-050)
• DARWIN EU® study:
  No
• Study countries:
  China
• Study description:
  This is a post-marketing observational study of Orgalutran in Chinese women undergoing controlled overian hyperstimulation during an assisted reproductive technology protocol. The primary objective is to characterize the safety and effectiveness of Orgalutran in the Chinese population in the setting of routine clinical practice in China.
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck & Co.

Multiple centres: 20 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 02/10/2014

Study start date

Planned: 30/04/2015

Actual: 28/04/2015

Data analysis start date

Planned: 13/06/2017

Actual: 06/06/2017

Date of final study report

Planned: 20/12/2017

Actual: 05/12/2017

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