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To Investigate Efficacy and Safety of a Single Injection of Org 36286 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (Ensure)(P05690/MK-8962-001)

NCT00702845 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 397

Last updated 2024-06-18

Study results available
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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.

Conditions

Interventions

DRUG

corifollitropin alfa (Org 36286)

100 µg corifollitropin alfa subcutaneous (SC) injection

DRUG

recFSH (follitropin beta)

150 IU recFSH SC injection

DRUG

gonadatropin releasing hormone (GnRH) antagonist (ganirelix)

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

DRUG

human chorion gonadatropin (hCG)

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

BIOLOGICAL

progesterone

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.

DRUG

placebo-recFSH (follitropin alfa)

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

DRUG

placebo-corifollitropin alfa

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

BIOLOGICAL

open-label recFSH

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

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
36 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-28
Primary Completion
2007-07-07
Completion
2007-11-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00702845 on ClinicalTrials.gov