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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 : January 11, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition Ovarian Carcinoma
Interventions Other: Laboratory Biomarker Analysis
Drug: Levonorgestrel
Other: Placebo
Enrollment 64
Recruitment Details The protocol opened to accrual 03/10/2008 and closed 11/26/2012Women who were are at increased risk for ovarian cancer and were intending to undergo prophylactic salpingo-oopherectomy were randomized to Levenorgestrel (0.15 mg/day) or Placebo for 4 to 6 weeks.
Pre-assignment Details  
Arm/Group Title Arm I (Levenorgestrel) Arm II (Placebo)
Hide Arm/Group Description Levenorgestrel (0.15 mg/day) for 4 to 6 weeks for 4 to 6 weeks Placebo for 4 to 6 weeks
Period Title: Overall Study
Started 33 31
Completed 33 31
Not Completed 0 0
Arm/Group Title Arm I (Levenorgestrel) Arm II (Placebo) Total
Hide Arm/Group Description Levenorgestrel (0.15 mg/day) for 4 to 6 weeks for 4 to 6 weeks Placebo for 4 to 6 weeks Total of all reporting groups
Overall Number of Baseline Participants 33 31 64
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 31 participants 64 participants
20-29 years
0
   0.0%
0
   0.0%
0
   0.0%
30-39 years
4
  12.1%
6
  19.4%
10
  15.6%
40-49 years
14
  42.4%
13
  41.9%
27
  42.2%
50-59 years
14
  42.4%
9
  29.0%
23
  35.9%
60-69 years
1
   3.0%
3
   9.7%
4
   6.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 31 participants 64 participants
Female
33
 100.0%
31
 100.0%
64
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Median Proportion Cells That Are Apoptotic in Epithelial Ovarian Tissue
Hide Description 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.
Time Frame Surgical specimen (4 - 6 weeks after entry)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with evaluable slides. 14 of the cases did not have ovarian tissue available for evaluation. 50 cases were available for the primary analysis.
Arm/Group Title Arm I (Levenorgestrel) Arm II (Placebo)
Hide Arm/Group Description:
Levenorgestrel (0.15 mg/day) for 4 to 6 weeks for 4 to 6 weeks
Placebo for 4 to 6 weeks
Overall Number of Participants Analyzed 26 24
Median (Inter-Quartile Range)
Unit of Measure: proportion of total cells
.093
(.024 to .25)
.115
(.033 to .329)
2.Primary Outcome
Title Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0
Hide Description 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.
Time Frame Up to 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible and treated patients who had toxicity on study.
Arm/Group Title Grade 1 CTCAE v 3.0 Arm I (Levonorgestrel) Grade 2 CTCAE v 3.0 Arm 1 (Levonorgestrel) Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel) Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel) Grade 5 CTCAE v3.0 Arm I (Levonorgestrel) Grade 1 CTCAE 3.0 Arm II (Placebo) Grade 2 CTCAE 3.0 Arm II (Placebo) Grade 3 CTCAE 3.0 Arm II (Placebo) Grade 4 CTCAE 3.0 Arm II (Placebo) Grade 5 CTCAE 3.0 Arm II (Placebo)
Hide Arm/Group Description:
Number of patients on arm 1 who experienced a grade 1 event using CTCAE v 3.0
Number of patients on arm 1 who experienced a grade 2 event using CTCAE v 3.0
Number of patients on arm 1 who experienced a grade 3 event using CTCAE v 3.0
Number of patients on arm ! who experienced a grade 4 event using CTCAE v. 3.0
Number of patients on arm I who experienced a grade 5 event using CTCAE v. 3.0
Number of patients on arm II who experienced a grade 1 event using CTCAE v.30
Number of patients on arm II who experienced a grade 2 event using CTCAE 3.0
Number of patients on arm II who experienced a grade 3 event using CTCAE 3.0
Number of patients on arm II who experienced a grade 4 event using CTCAE 3.0
Number of patients on arm II who experienced a grade 5 event using CTCAE 3.0
Overall Number of Participants Analyzed 33 33 33 33 33 31 31 31 31 31
Measure Type: Count of Participants
Unit of Measure: Participants
Allergy/Immunology
1
   3.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.2%
0
   0.0%
0
   0.0%
0
   0.0%
Constitutional Symptoms
1
   3.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.2%
0
   0.0%
0
   0.0%
0
   0.0%
Cardiac
1
   3.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Dermatology/Skin
2
   6.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Endocrine
1
   3.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   6.5%
1
   3.2%
0
   0.0%
0
   0.0%
0
   0.0%
Gastrointestinal
1
   3.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.2%
0
   0.0%
0
   0.0%
0
   0.0%
Renal/Genitourinary
2
   6.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hemorrhage/Bleeding
3
   9.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Blood/Bone Marrow
5
  15.2%
2
   6.1%
0
   0.0%
0
   0.0%
0
   0.0%
3
   9.7%
1
   3.2%
0
   0.0%
0
   0.0%
0
   0.0%
Infection
0
   0.0%
0
   0.0%
1
   3.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.2%
0
   0.0%
0
   0.0%
0
   0.0%
Metabolic/Laboratory
2
   6.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   6.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Neurology
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Pulmonary/Upper Respiratory
1
   3.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Pain
3
   9.1%
1
   3.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   6.5%
2
   6.5%
0
   0.0%
0
   0.0%
0
   0.0%
Sexual/Reproductive Function
3
   9.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Proportion of Proliferation as Measured by Ki-67
Hide Description [Not Specified]
Time Frame Time of surgery (4 to 6 weeks after entry)
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible, treated patients with an evaluable sample.
Arm/Group Title Arm I (Levenorgestrel) Arm II (Placebo)
Hide Arm/Group Description:
Levenorgestrel (0.15 mg/day) for 4 to 6 weeks for 4 to 6 weeks
Placebo for 4 to 6 weeks
Overall Number of Participants Analyzed 32 30
Median (Inter-Quartile Range)
Unit of Measure: Proportion of cells exhibiting Ki-67
.003
(0 to .008)
.008
(.002 to .028)
4.Secondary Outcome
Title Patients With High Expression of Transforming Growth Factor-beta 1
Hide Description [Not Specified]
Time Frame Baseline to time of surgery (4 to 6 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible, treated and evaluable for Transforming Growth factor-beta
Arm/Group Title Arm I (Levenorgestrel) Arm II (Placebo)
Hide Arm/Group Description:
Levenorgestrel (0.15 mg/day) for 4 to 6 weeks for 4 to 6 weeks
Placebo for 4 to 6 weeks
Overall Number of Participants Analyzed 29 20
Measure Type: Count of Participants
Unit of Measure: Participants
6
  20.7%
3
  15.0%
5.Other Pre-specified Outcome
Title Median Proportion Cells That Are Apoptotic in Fallopian Tube Tissue
Hide Description 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
Time Frame Surgical specimen (4-6 weeks after entry)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with evaluable slides
Arm/Group Title Arm I (Levenorgestrel) Arm II (Placebo)
Hide Arm/Group Description:
Levenorgestrel (0.15 mg/day) for 4 to 6 weeks for 4 to 6 weeks
Placebo for 4 to 6 weeks
Overall Number of Participants Analyzed 32 30
Median (Inter-Quartile Range)
Unit of Measure: proportion of total cells
.205
(.07 to .395)
.079
(.01 to .25)
Time Frame Study Treatment - 4 - 6 weeks from enrollment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Levenorgestrel) Arm II (Placebo)
Hide Arm/Group Description Levenorgestrel (0.15 mg/day) for 4 to 6 weeks for 4 to 6 weeks Placebo for 4 to 6 weeks
All-Cause Mortality
Arm I (Levenorgestrel) Arm II (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Levenorgestrel) Arm II (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/31 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Levenorgestrel) Arm II (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   16/33 (48.48%)   14/31 (45.16%) 
Blood and lymphatic system disorders     
Neutrophils * 1  1/33 (3.03%)  0/31 (0.00%) 
Blood/Bone Marrow - Other * 1  0/33 (0.00%)  1/31 (3.23%) 
Leukocytes * 1  0/33 (0.00%)  2/31 (6.45%) 
Hemoglobin * 1  6/33 (18.18%)  3/31 (9.68%) 
Cardiac disorders     
Hypertension * 1  1/33 (3.03%)  0/31 (0.00%) 
Endocrine disorders     
Hot Flashes * 1  1/33 (3.03%)  2/31 (6.45%) 
Hyperthyroidism * 1  0/33 (0.00%)  1/31 (3.23%) 
Gastrointestinal disorders     
Flatulence * 1  0/33 (0.00%)  1/31 (3.23%) 
Distention * 1  0/33 (0.00%)  1/31 (3.23%) 
Constipation * 1  1/33 (3.03%)  0/31 (0.00%) 
General disorders     
Sweating * 1  1/33 (3.03%)  0/31 (0.00%) 
Fever * 1  0/33 (0.00%)  1/31 (3.23%) 
Pain: Chest /Thorax Nos * 1  1/33 (3.03%)  0/31 (0.00%) 
Pain: Head/Headache * 1  2/33 (6.06%)  2/31 (6.45%) 
Pain: Back * 1  0/33 (0.00%)  1/31 (3.23%) 
Pain: Bladder * 1  1/33 (3.03%)  0/31 (0.00%) 
Pain: Abdominal Pain Nos * 1  1/33 (3.03%)  1/31 (3.23%) 
Immune system disorders     
Allergy/Immunology - Other * 1  1/33 (3.03%)  0/31 (0.00%) 
Rhinitis * 1  0/33 (0.00%)  1/31 (3.23%) 
Infections and infestations     
Infection - Other * 1  1/33 (3.03%)  0/31 (0.00%) 
Inf Unknown Anc: Bronchus * 1  0/33 (0.00%)  1/31 (3.23%) 
Inf Unknown Anc: Urinary Tract Nos * 1  1/33 (3.03%)  0/31 (0.00%) 
Inf Unknown Anc: Colon * 1  1/33 (3.03%)  0/31 (0.00%) 
Metabolism and nutrition disorders     
Hypocalcemia * 1  1/33 (3.03%)  1/31 (3.23%) 
Hyperglycemia * 1  1/33 (3.03%)  0/31 (0.00%) 
Hypokalemia * 1  0/33 (0.00%)  1/31 (3.23%) 
Nervous system disorders     
Dizziness * 1  0/33 (0.00%)  1/31 (3.23%) 
Renal and urinary disorders     
Urinary Retention * 1  1/33 (3.03%)  0/31 (0.00%) 
Urinary Frequency * 1  1/33 (3.03%)  0/31 (0.00%) 
Reproductive system and breast disorders     
Sexual/Reproductive Function: Other * 1  1/33 (3.03%)  1/31 (3.23%) 
Vaginal Discharge * 1  2/33 (6.06%)  0/31 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea * 1  1/33 (3.03%)  0/31 (0.00%) 
Skin and subcutaneous tissue disorders     
Acne * 1  2/33 (6.06%)  0/31 (0.00%) 
Dermatology/Skin - Other * 1  0/33 (0.00%)  1/31 (3.23%) 
Vascular disorders     
Hemorrhage, Gu - Vagina * 1  3/33 (9.09%)  1/31 (3.23%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Linda Gedeon for James Kauderer, MA
Organization: NRG Oncology
Phone: 716-845-1169
EMail: lgedeon@gogstats.org
Layout table for additonal information
Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00445887     History of Changes
Other Study ID Numbers: GOG-0214
NCI-2009-00588 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GOG-0214
CDR0000532268
GOG-0214 ( Other Identifier: Gynecologic Oncology Group )
GOG-0214 ( Other Identifier: DCP )
GOG-0214 ( Other Identifier: CTEP )
U10CA101165 ( U.S. NIH Grant/Contract )
First Submitted: March 7, 2007
First Posted: March 9, 2007
Results First Submitted: January 9, 2017
Results First Posted: January 11, 2018
Last Update Posted: January 11, 2018