Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004763
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase II Randomized Study of Leuprolide Vs Oral Contraceptive Therapy Vs Leuprolide and Oral Contraceptive Therapy for Ovarian Hyperandrogenism
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-12
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 Evaluate the beneficial effects of leuprolide depot oral contraceptive therapy and leuprolideoral contraceptive therapy in the management of patients with ovarian hyperandrogenism
I Evaluate the beneficial effects of leuprolide depot oral contraceptive therapy and leuprolideoral contraceptive therapy in the management of patients with ovarian hyperandrogenism
Detailed Description:
PROTOCOL OUTLINE This is a randomized study Patients are randomly assigned to a 6-month course of leuprolide versus ethinyl estradiolnorethindrone Ovcon 35 versus leuprolide plus Ovcon 35 Leuprolide is administered intramuscularly in depot form every 28 days
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 |
|---|---|---|---|
| BCM-11717 | None | None | None |