Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005654
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-05-02
Brief Title:
Randomized Study of the Effect of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Obese Women With Polycystic Ovary Syndrome
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-04
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:
OBJECTIVES
I Determine whether reduction of serum insulin levels by metformin increases ovulatory response to clomiphene or spontaneous ovulation in obese women with polycystic ovary syndrome
I Determine whether reduction of serum insulin levels by metformin increases ovulatory response to clomiphene or spontaneous ovulation in obese women with polycystic ovary syndrome
Detailed Description:
PROTOCOL OUTLINE This is a randomized double blind placebo controlled multicenter study Patients are randomized to one of two treatment arms
Patients receive oral metformin arm I or oral placebo arm II three times daily for 8 weeks All patients who do not ovulate by day 28 receive oral clomiphene citrate daily on days 36-40
Patients receive oral metformin arm I or oral placebo arm II three times daily for 8 weeks All patients who do not ovulate by day 28 receive oral clomiphene citrate daily on days 36-40
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UVA-WSE023 | None | None | None |