Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00445887
Status:
COMPLETED
Last Update Posted:
2019-11-19
First Post:
2007-03-07
Brief Title:
Levonorgestrel in Preventing Ovarian Cancer in Patients at High Risk for Ovarian Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
Phase II Double Blind Randomized Trial Evaluating the Biologic Effect of Levonorgestrel on the Double Blind Randomized Trial Evaluating the Biologic Effect of Levonorgestrel on the Ovarian Epithelium in Women at High Risk for Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2019-11
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 randomized phase II trial is studying how well levonorgestrel works in preventing ovarian cancer in patients at high risk for ovarian cancer Chemoprevention is the use of certain drugs to keep cancer from forming The use of levonorgestrel may prevent ovarian cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the impact of levonorgestrel on the relative frequency of apoptosis in the ovarian epithelium of patients at high risk for ovarian cancer
SECONDARY OBJECTIVES
I Estimate the impact of this drug on proliferation and transforming growth factor-beta TGF-beta expression in the ovarian epithelium of these patients
II Assess the safety of this drug in these patients
OUTLINE This is a prospective randomized placebo-controlled double-blind study Patients are stratified according to menopausal status premenopausal vs postmenopausal Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive oral levonorgestrel once daily
ARM II Patients receive oral placebo once daily
In both arms treatment continues for 4-6 weeks in the absence of disease progression or unacceptable toxicity including on the day of surgery Patients then undergo prophylactic salpingo-oophorectomy After completion of study therapy patients are followed at 1 year
NOTE Patients who are unable to have surgery completed during the expected 4-6 weeks may continue levonorgestrel or placebo for a time period no 5 months Patients unable to undergo surgery within 5 months are removed from the study
I Determine the impact of levonorgestrel on the relative frequency of apoptosis in the ovarian epithelium of patients at high risk for ovarian cancer
SECONDARY OBJECTIVES
I Estimate the impact of this drug on proliferation and transforming growth factor-beta TGF-beta expression in the ovarian epithelium of these patients
II Assess the safety of this drug in these patients
OUTLINE This is a prospective randomized placebo-controlled double-blind study Patients are stratified according to menopausal status premenopausal vs postmenopausal Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive oral levonorgestrel once daily
ARM II Patients receive oral placebo once daily
In both arms treatment continues for 4-6 weeks in the absence of disease progression or unacceptable toxicity including on the day of surgery Patients then undergo prophylactic salpingo-oophorectomy After completion of study therapy patients are followed at 1 year
NOTE Patients who are unable to have surgery completed during the expected 4-6 weeks may continue levonorgestrel or placebo for a time period no 5 months Patients unable to undergo surgery within 5 months are removed from the study
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA101165 | NIH | CTEP | httpsreporternihgovquickSearchU10CA101165 |
| NCI-2009-00588 | REGISTRY | None | None |
| 10-01367 | None | None | None |
| CDR0000532268 | None | None | None |
| GOG-0214 | None | None | None |
| GOG-0214 | OTHER | None | None |
| GOG-0214 | OTHER | None | None |
| GOG-0214 | OTHER | None | None |