MedTrace Logo

Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Phase II Clinical Trials of Org 36286 (Study 38817)(P06054)(COMPLETED)

NCT00702195 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 29

Last updated 2024-08-15

No results posted yet for this study

Summary

The objective of this trial was to evaluate whether Org 36286 treatment in any Phase IIa clinical development trial of Org 36286 for OI or COH in assisted reproductive treatment programs was safe for pregnant subjects and their offspring. Data from subjects who participated in Trials 38805 and 38807 and became pregnant were evaluated.

Conditions

  • Pregnancy

Interventions

DRUG

Org 36286 (corifollitropin alfa)

single dose of Org 36286 (corifollitropin alfa) administered under protocol 38805/38807

DRUG

Placebo

single dose of placebo (administered under protocol 38805)

DRUG

recFSH

150 IU recFSH daily (reference group administered under protocol 38807)

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Eligibility

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

Timeline & Regulatory

Start
2002-01-01
Primary Completion
2003-09-15
Completion
2003-09-15

More Related Trials

Entities

Drugs

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 NCT00702195 on ClinicalTrials.gov