Overview

Rekovelle PK Trial in Chinese Women

Status:
Completed
Trial end date:
2019-12-16
Target enrollment:
Participant gender:
Summary
FE 999049 is a gonadotropin preparation containing recombinant human follicle stimulating hormone (rhFSH) under development by Ferring Pharmaceuticals. It is intended for controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle. In previous trials the exposure to and dose proportionality of FE 999049 in a clinically relevant dose range in Caucasian and Japanese healthy women have been shown to be very similar. This is a trial in healthy Chinese women investigating the pharmacokinetics, safety, and tolerability of a single subcutaneous dose of FE 999049.
Phase:
Phase 1
Details
Lead Sponsor:
Ferring Pharmaceuticals
Treatments:
Follicle Stimulating Hormone