Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-27 @ 11:08 PM
Study NCT ID:
NCT01599494
Status:
WITHDRAWN
Last Update Posted:
2022-02-03
First Post:
2012-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Efficacy and Safety Study of Corifollitropin Alfa (MK-8962) in Contrast to Recombinant FSH for Use in Controlled Ovarian Stimulation of Indian Women (P07056, Also Known as MK-8962-029)
Sponsor:
Organon and Co
Organization:
Study Overview
Official Title:
A Multi-center, Open-label, Randomized Trial in India to Investigate the Efficacy and Safety of a Single Injection of MK-8962 (Corifollitropin Alfa) to Induce Multifollicular Development for Controlled Ovarian Stimulation Using Daily Recombinant FSH as a Reference (Phase III, Protocol No. MK-8962-029-00 [Also Known as SCH900962, P07056])
Status:
WITHDRAWN
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study, conducted in India, will be recruiting women participants who are between the ages of 18 and 42, and who have an indication for controlled ovarian stimulation (COS), but have not yet undergone in-vitro fertilization and/or intracytoplasmic sperm injection (IVF/ICSI). The study is designed to compare the difference in oocyte (immature egg cell) production after administration of the investigative drug, MK-8962 (corifollitropin alfa) + recombinant follicle stimulating hormone (recFSH), in contrast to use of only the reference drug, recFSH.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| MK-8962-029 | OTHER | Merck | View |