Trials / Completed
CompletedNCT04150861
Rekovelle PK Trial in Chinese Women
An Open-label Trial Investigating the Pharmacokinetics of FE 999049 Given as a Single Subcutaneous Dose in Gonadotropin Down-regulated Healthy Chinese Women
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Ferring Pharmaceuticals · Industry
- Sex
- Female
- Age
- 21 Years – 40 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Follitropin Delta | Solution for Injection, subcutaneous administration |
Timeline
- Start date
- 2019-06-23
- Primary completion
- 2019-11-28
- Completion
- 2019-12-16
- First posted
- 2019-11-05
- Last updated
- 2023-02-14
- Results posted
- 2020-12-24
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04150861. Inclusion in this directory is not an endorsement.