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A Phase 2, Trial to Investigate the Dose-Response Relationship of a Single Injection of Org 36286 (Corifollitropin Alfa) to Initiate Multiple Follicular Growth in a Controlled Ovarian (Study 38826)(P06055)(COMPLETED)

NCT00598208 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 325

Last updated 2024-08-15

No results posted yet for this study

Summary

The primary objective of this trial is to investigate the dose -response relationship of a single injection of Org 38286 to initiate multifollicular growth for the first seven days in a controlled ovarian hyperstimulation (COH) protocol for IVF or ICSI.

Conditions

  • Fertilization

Interventions

DRUG

corifollitropin alfa

On Cycle Day 2, a single injection of 60 μg, 120 μg, or 180 μg Org 36286 was administered. One week later (Treatment Day 8), treatment was continued with a fixed daily subcutaneous (SC) dose of 150 IU Puregon® up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and up to and including the Day of hCG. The maximum total treatment duration was 19 days.

DRUG

Follitropin beta injection

Starting on Cycle Day 2, a fixed daily dose of 150 IU Puregon® SC was administered for the entire stimulation period up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and given up to and including the day of hCG. The maximum total treatment duration was 19 days.

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2003-05-19
Primary Completion
2004-03-15
Completion
2004-03-15

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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 NCT00598208 on ClinicalTrials.gov