CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Follitropin Deltadrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04150861
NCT04150861Phase 1Completed
CompareCT.gov

An Open-label Trial Investigating the Pharmacokinetics of FE 999049 Given as a Single Subcutaneous Dose in Gonadotropin Down-regulated Healthy Chinese Women

Ferring Pharmaceuticals·interventional·Posted Nov 5, 2019·Updated Feb 14, 2023

In Brief

A Phase 1 clinical trial evaluating Follitropin Delta for Infertility. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfertility
CountriesChina
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedNov 5, 2019
Enrollment StartJun 23, 2019
Primary CompletionNov 28, 2019
Study CompletionDec 16, 2019
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 6.7 years ago

Interventions

Follitropin Deltadrug

Solution for Injection, subcutaneous administration