Levonorgestrel in Preventing Ovarian Cancer in Patients at High Risk for Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT00445887|
Recruitment Status : Completed
First Posted : March 9, 2007
Results First Posted : January 11, 2018
Last Update Posted : November 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Carcinoma||Other: Laboratory Biomarker Analysis Drug: Levonorgestrel Other: Placebo||Phase 2|
I. Determine the impact of levonorgestrel on the relative frequency of apoptosis in the ovarian epithelium of patients at high risk for ovarian cancer.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Study Start Date :||March 10, 2008|
|Actual Primary Completion Date :||December 11, 2013|
Experimental: Arm I (levonorgestrel)
Patients receive oral levonorgestrel once daily.
Other: Laboratory Biomarker Analysis
Placebo Comparator: Arm II (placebo)
Patients receive oral placebo once daily.
Other: Laboratory Biomarker Analysis
- Median Proportion Cells That Are Apoptotic in Epithelial Ovarian Tissue [ Time Frame: Surgical specimen (4 - 6 weeks after entry) ]The median proportion of cells that are considered to be apoptotic are counted in the ovarian tissue sample, among the total number of cells available in the sample slide.
- Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 [ Time Frame: Up to 20 weeks ]Participants were graded using CTCAE v.30 criteria. Grade 1 is the least severe grade. Each adverse event lists criteria for grading, grade 1 being mild, up to grade 5. Grade 4 is generally life threatening. Grade 5 is death.
- Proportion of Proliferation as Measured by Ki-67 [ Time Frame: Time of surgery (4 to 6 weeks after entry) ]
- Patients With High Expression of Transforming Growth Factor-beta 1 [ Time Frame: Baseline to time of surgery (4 to 6 weeks) ]
- Median Proportion Cells That Are Apoptotic in Fallopian Tube Tissue [ Time Frame: Surgical specimen (4-6 weeks after entry) ]The median proportion of cells that are considered to be apoptotic are counted in the fallopian tube tissue sample, among the total number of cells available in the sample slide
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445887
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|Principal Investigator:||Gustavo C Rodriguez||Gynecologic Oncology Group|