Post-Marketing Surveillance (PMS) Protocol of REKOVELLE Pre-Filled Pen (Follitropin Delta)

Ferring

Status: Completed

Conditions: Infertility, Female

Treatments: Other: Other: Non intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT04654039

000385

Details and patient eligibility

About

This post-marketing surveillance study was conducted in accordance with the regulations for re-examination of domestic new drugs (Standard for Re-Examination of New Drugs: Ministry of Food and Drug Safety [MFDS]: Notification No. 2017-95, 21 Nov, 2017).

It was important to monitor the pattern of drug use in general practice for a long term after marketing authorization, and to investigate and identify potential new adverse events (AEs) and their onset status that were not observed during the drug development phases and any potential factors that affect safety and effectiveness of the new drug.

Enrollment: 728 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who were prescribed with REKOVELLE (follitropin delta) for the first time according to the approved administration method and dose
• Participants who have consented to personal information use

Exclusion criteria

• Participants who are prohibited from use according to the special warnings and precautions for use of REKOVELLE (follitropin delta)

Trial design

728 participants in 1 patient group

Treatment of Infertility

Description:

Non intervention

Treatment:

Other: Other: Non intervention