Status:
COMPLETED
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Phase II Clinical Trials of Org 36286 (Study 38817)(P06054)(COMPLETED)
Lead Sponsor:
Organon and Co
Conditions:
Pregnancy
Eligibility:
FEMALE
18-39 years
Brief 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 ...
Detailed Description
This was an open prospective follow-up trial to monitor pregnancy, delivery, and neonatal outcome of women who became pregnant during any Phase IIa clinical trial of Org 36286 for OI or COH for IVF. F...
Eligibility Criteria
Inclusion
- Subjects taking part in any clinical development trial of Org 36286 for OI or COH for IVF in Phase IIa;
- Ongoing pregnancy confirmed by ultrasonography (USS) at or beyond 12 weeks of gestation;
- Able and willing to give written informed consent.
Exclusion
- None
Key Trial Info
Start Date :
January 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 15 2003
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00702195
Start Date
January 1 2002
End Date
September 15 2003
Last Update
August 15 2024
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