CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 397 enrolled
Drug / intervention
corifollitropin alfa (Org 36286) +7 moredrug
Likely dose
corifollitropin alfa (Org 36286) 100 µgfrom 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/NCT00702845
NCT00702845Phase 3Completed
CompareCT.gov

A Phase III, Randomized, Double-blind, Active-controlled, Equivalence Clinical Trial to Investigate the Efficacy and Safety of a Single Injection of 100 µg Org 36286 (Corifollitropin Alfa) to Induce Multifollicular Development for Controlled Ovarian Stimulation (COS) Using Daily Recombinant FSH (recFSH) as a Reference

Organon and Co·interventional·Posted Jun 20, 2008·Updated Jun 18, 2024

In Brief

A Phase 3 clinical trial evaluating corifollitropin alfa (Org 36286), recFSH (follitropin beta), and 6 other interventions for Infertility. Completed, enrolled 397 participants.

Detailed Summary

Clinical trial objectives are to investigate the efficacy and safety of a single injection of 100 μg Org 36286 in women weighing 60 kg or less to induce multifollicular development for controlled ovarian stimulation (COS), using daily recFSH as a reference.

Study Details

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

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 20, 2008
Enrollment StartDec 28, 2006
Primary CompletionJul 7, 2007
Study CompletionNov 15, 2007
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 18.0 years ago

Interventions

corifollitropin alfa (Org 36286)drug

100 µg corifollitropin alfa subcutaneous (SC) injection

recFSH (follitropin beta)drug

150 IU recFSH SC injection

gonadatropin releasing hormone (GnRH) antagonist (ganirelix)drug

GnRH antagonist (ganirelix) administered SC at a dose of 0.25 mg/day

human chorion gonadatropin (hCG)drug

hCG 5,000 IU or 10,000 IU administered SC

progesteronebiological

Progesterone was started on the day of oocyte pick-up (OPU) and continued for at least 6 weeks or up to menses. Participants received at least 600 mg/day vaginally or 50 mg/day IM.

placebo-recFSH (follitropin alfa)drug

Placebo-recFSH administered at the equivalent volume of 150 IU/day.

placebo-corifollitropin alfadrug

Single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle.

open-label recFSHbiological

Open-label recFSH administered up to a maximum dose of 200 IU/day.