Ovarian Carcinoma
Conditions
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.
Interventions
OTHERLaboratory Biomarker Analysis
Correlative studies
DRUGLevonorgestrel
Given orally
OTHERPlacebo
Given orally
Sponsors
National Cancer Institute (NCI)
Gynecologic Oncology Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At increased genetic risk for ovarian cancer AND planning to undergo risk-reducing salpingo-oophorectomy (RRSO) * Has ≥ 1 intact ovary * Patients enrolled on clinical trial GOG-0199 and planning to undergo RRSO allowed * Submission of fixed ovarian tissue (FN01) required * Must meet 1 of the following additional criteria: * Family of the patient has a documented deleterious BRCA1 or BRCA2 mutation and either the patient herself has tested positive for a deleterious BRCA1 or BRCA2 mutation or the patient has a first- or second-degree relative with a deleterious BRCA1 or BRCA2 mutation * No patient with a deleterious BRCA1 or BRCA2 mutation whose first- or second-degree relative has tested negative for the exact same mutation * The family contains members with ≥ 2 ovarian\* and/or breast cancers among the first- or second-degree relatives (male relatives must be counted) of the patient within the same lineage (this condition may be satisfied by multiple primary cancers in the same person or, where breast cancer is required to meet this criterion, ≥ 1 breast cancer must have been diagnosed prior to menopause or at age ≤ 50 years if age at menopause is unknown) * The patient is of Ashkenazi Jewish ethnicity (lineage via the mother) with one first- degree or two second-degree maternal relatives with breast and/or ovarian cancer\* (where breast cancer is required to meet this criterion, ≥ 1 breast cancer must have been diagnosed prior to menopause or at age ≤ 50 years if age at menopause is unknown) * The probability of carrying a BRCA1 or BRCA2 mutation, given the family pedigree of breast and ovarian cancers, exceeds 20%, as calculated by BRCAPRO * No prior history of ovarian cancer, including low malignant potential cancers, or primary papillary serous carcinoma of the peritoneum * No prior or concurrent history of breast cancer, including ductal carcinoma in situ (DCIS) of the breast * Women with a history of hormone receptor-negative breast cancer (both estrogen receptor-negative and progesterone receptor-negative) are eligible * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective nonhormonal contraception prior to the prophylactic salpingo-oophorectomy * No prior history of deep vein thrombosis, stroke, liver disease, or heart attack * No prior history of myocardial infarction * No known bleeding disorders or hypercoagulable states * No other malignancy, including ductal carcinoma in situ, within 1 year of systemic therapy, except for nonmelanoma skin cancer * No prior chemotherapy regimen lasting ≥ 12 months * No oral or intrauterine hormonal contraception or hormonal replacement therapy within the past 3 months or injectable medroxyprogesterone within the past 12 months * No intraperitoneal surgery within the past 3 months (including laparoscopy) * No prior or concurrent radiotherapy to the pelvis * No concurrent hormonal contraception * No concurrent tamoxifen, raloxifene, estrogen, progesterone-like hormones, or other hormonal medication (including hormone replacement therapy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Proportion Cells That Are Apoptotic in Epithelial Ovarian Tissue | 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 | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of Proliferation as Measured by Ki-67 | Time of surgery (4 to 6 weeks after entry) |
| Patients With High Expression of Transforming Growth Factor-beta 1 | Baseline to time of surgery (4 to 6 weeks) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Median Proportion Cells That Are Apoptotic in Fallopian Tube Tissue | 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 |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Arm I (Levenorgestrel) Levenorgestrel (0.15 mg/day) for 4 to 6 weeks for 4 to 6 weeks | 33 |
| Arm II (Placebo) Placebo for 4 to 6 weeks | 31 |
| Total | 64 |
Baseline characteristics
| Characteristic | Arm I (Levenorgestrel) | Arm II (Placebo) | Total |
|---|---|---|---|
| Age, Customized 20-29 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 30-39 years | 4 Participants | 6 Participants | 10 Participants |
| Age, Customized 40-49 years | 14 Participants | 13 Participants | 27 Participants |
| Age, Customized 50-59 years | 14 Participants | 9 Participants | 23 Participants |
| Age, Customized 60-69 years | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Female | 33 Participants | 31 Participants | 64 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 33 | 14 / 31 |
| serious Total, serious adverse events | 0 / 33 | 0 / 31 |
Outcome results
Primary
Median Proportion Cells That Are Apoptotic in Epithelial Ovarian Tissue
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)
Population: 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 | Measure | Value (MEDIAN) |
|---|---|---|
| Arm I (Levenorgestrel) | Median Proportion Cells That Are Apoptotic in Epithelial Ovarian Tissue | .093 proportion of total cells |
| Arm II (Placebo) | Median Proportion Cells That Are Apoptotic in Epithelial Ovarian Tissue | .115 proportion of total cells |
Primary
Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0
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
Population: All eligible and treated patients who had toxicity on study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Levenorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Sexual/Reproductive Function | 3 Participants |
| Arm I (Levenorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Allergy/Immunology | 1 Participants |
| Arm I (Levenorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Neurology | 0 Participants |
| Arm I (Levenorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Gastrointestinal | 1 Participants |
| Arm I (Levenorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Constitutional Symptoms | 1 Participants |
| Arm I (Levenorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Infection | 0 Participants |
| Arm I (Levenorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Hemorrhage/Bleeding | 3 Participants |
| Arm I (Levenorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Cardiac | 1 Participants |
| Arm I (Levenorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Blood/Bone Marrow | 5 Participants |
| Arm I (Levenorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Pain | 3 Participants |
| Arm I (Levenorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Metabolic/Laboratory | 2 Participants |
| Arm I (Levenorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Dermatology/Skin | 2 Participants |
| Arm I (Levenorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Pulmonary/Upper Respiratory | 1 Participants |
| Arm I (Levenorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Renal/Genitourinary | 2 Participants |
| Arm I (Levenorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Endocrine | 1 Participants |
| Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Renal/Genitourinary | 0 Participants |
| Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Pain | 1 Participants |
| Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Pulmonary/Upper Respiratory | 0 Participants |
| Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Cardiac | 0 Participants |
| Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Infection | 0 Participants |
| Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Metabolic/Laboratory | 0 Participants |
| Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Blood/Bone Marrow | 2 Participants |
| Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Endocrine | 0 Participants |
| Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Dermatology/Skin | 0 Participants |
| Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Neurology | 0 Participants |
| Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Gastrointestinal | 0 Participants |
| Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Sexual/Reproductive Function | 0 Participants |
| Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Allergy/Immunology | 0 Participants |
| Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Constitutional Symptoms | 0 Participants |
| Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Hemorrhage/Bleeding | 0 Participants |
| Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Gastrointestinal | 0 Participants |
| Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Allergy/Immunology | 0 Participants |
| Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Pulmonary/Upper Respiratory | 0 Participants |
| Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Hemorrhage/Bleeding | 0 Participants |
| Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Pain | 0 Participants |
| Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Renal/Genitourinary | 0 Participants |
| Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Neurology | 0 Participants |
| Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Constitutional Symptoms | 0 Participants |
| Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Cardiac | 0 Participants |
| Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Dermatology/Skin | 0 Participants |
| Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Infection | 1 Participants |
| Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Endocrine | 0 Participants |
| Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Sexual/Reproductive Function | 0 Participants |
| Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Blood/Bone Marrow | 0 Participants |
| Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Metabolic/Laboratory | 0 Participants |
| Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Neurology | 0 Participants |
| Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Blood/Bone Marrow | 0 Participants |
| Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Constitutional Symptoms | 0 Participants |
| Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Pain | 0 Participants |
| Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Cardiac | 0 Participants |
| Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Allergy/Immunology | 0 Participants |
| Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Pulmonary/Upper Respiratory | 0 Participants |
| Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Dermatology/Skin | 0 Participants |
| Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Endocrine | 0 Participants |
| Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Gastrointestinal | 0 Participants |
| Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Metabolic/Laboratory | 0 Participants |
| Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Renal/Genitourinary | 0 Participants |
| Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Sexual/Reproductive Function | 0 Participants |
| Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Infection | 0 Participants |
| Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Hemorrhage/Bleeding | 0 Participants |
| Grade 5 CTCAE v3.0 Arm I (Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Neurology | 0 Participants |
| Grade 5 CTCAE v3.0 Arm I (Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Sexual/Reproductive Function | 0 Participants |
| Grade 5 CTCAE v3.0 Arm I (Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Dermatology/Skin | 0 Participants |
| Grade 5 CTCAE v3.0 Arm I (Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Constitutional Symptoms | 0 Participants |
| Grade 5 CTCAE v3.0 Arm I (Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Renal/Genitourinary | 0 Participants |
| Grade 5 CTCAE v3.0 Arm I (Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Blood/Bone Marrow | 0 Participants |
| Grade 5 CTCAE v3.0 Arm I (Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Pulmonary/Upper Respiratory | 0 Participants |
| Grade 5 CTCAE v3.0 Arm I (Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Infection | 0 Participants |
| Grade 5 CTCAE v3.0 Arm I (Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Hemorrhage/Bleeding | 0 Participants |
| Grade 5 CTCAE v3.0 Arm I (Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Cardiac | 0 Participants |
| Grade 5 CTCAE v3.0 Arm I (Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Gastrointestinal | 0 Participants |
| Grade 5 CTCAE v3.0 Arm I (Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Metabolic/Laboratory | 0 Participants |
| Grade 5 CTCAE v3.0 Arm I (Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Pain | 0 Participants |
| Grade 5 CTCAE v3.0 Arm I (Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Allergy/Immunology | 0 Participants |
| Grade 5 CTCAE v3.0 Arm I (Levonorgestrel) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Endocrine | 0 Participants |
| Grade 1 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Hemorrhage/Bleeding | 1 Participants |
| Grade 1 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Allergy/Immunology | 0 Participants |
| Grade 1 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Constitutional Symptoms | 0 Participants |
| Grade 1 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Cardiac | 0 Participants |
| Grade 1 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Dermatology/Skin | 1 Participants |
| Grade 1 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Endocrine | 2 Participants |
| Grade 1 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Gastrointestinal | 0 Participants |
| Grade 1 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Renal/Genitourinary | 0 Participants |
| Grade 1 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Blood/Bone Marrow | 3 Participants |
| Grade 1 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Infection | 0 Participants |
| Grade 1 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Metabolic/Laboratory | 2 Participants |
| Grade 1 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Neurology | 1 Participants |
| Grade 1 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Pulmonary/Upper Respiratory | 0 Participants |
| Grade 1 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Pain | 2 Participants |
| Grade 1 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Sexual/Reproductive Function | 1 Participants |
| Grade 2 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Neurology | 0 Participants |
| Grade 2 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Metabolic/Laboratory | 0 Participants |
| Grade 2 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Hemorrhage/Bleeding | 0 Participants |
| Grade 2 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Sexual/Reproductive Function | 0 Participants |
| Grade 2 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Endocrine | 1 Participants |
| Grade 2 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Cardiac | 0 Participants |
| Grade 2 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Infection | 1 Participants |
| Grade 2 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Blood/Bone Marrow | 1 Participants |
| Grade 2 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Pain | 2 Participants |
| Grade 2 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Constitutional Symptoms | 1 Participants |
| Grade 2 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Renal/Genitourinary | 0 Participants |
| Grade 2 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Pulmonary/Upper Respiratory | 0 Participants |
| Grade 2 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Dermatology/Skin | 0 Participants |
| Grade 2 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Allergy/Immunology | 1 Participants |
| Grade 2 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Gastrointestinal | 1 Participants |
| Grade 3 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Infection | 0 Participants |
| Grade 3 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Renal/Genitourinary | 0 Participants |
| Grade 3 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Hemorrhage/Bleeding | 0 Participants |
| Grade 3 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Gastrointestinal | 0 Participants |
| Grade 3 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Metabolic/Laboratory | 0 Participants |
| Grade 3 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Endocrine | 0 Participants |
| Grade 3 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Neurology | 0 Participants |
| Grade 3 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Dermatology/Skin | 0 Participants |
| Grade 3 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Sexual/Reproductive Function | 0 Participants |
| Grade 3 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Pulmonary/Upper Respiratory | 0 Participants |
| Grade 3 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Cardiac | 0 Participants |
| Grade 3 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Constitutional Symptoms | 0 Participants |
| Grade 3 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Pain | 0 Participants |
| Grade 3 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Allergy/Immunology | 0 Participants |
| Grade 3 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Blood/Bone Marrow | 0 Participants |
| Grade 4 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Dermatology/Skin | 0 Participants |
| Grade 4 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Blood/Bone Marrow | 0 Participants |
| Grade 4 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Gastrointestinal | 0 Participants |
| Grade 4 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Cardiac | 0 Participants |
| Grade 4 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Hemorrhage/Bleeding | 0 Participants |
| Grade 4 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Pulmonary/Upper Respiratory | 0 Participants |
| Grade 4 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Renal/Genitourinary | 0 Participants |
| Grade 4 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Constitutional Symptoms | 0 Participants |
| Grade 4 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Sexual/Reproductive Function | 0 Participants |
| Grade 4 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Infection | 0 Participants |
| Grade 4 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Pain | 0 Participants |
| Grade 4 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Endocrine | 0 Participants |
| Grade 4 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Metabolic/Laboratory | 0 Participants |
| Grade 4 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Allergy/Immunology | 0 Participants |
| Grade 4 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Neurology | 0 Participants |
| Grade 5 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Metabolic/Laboratory | 0 Participants |
| Grade 5 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Dermatology/Skin | 0 Participants |
| Grade 5 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Blood/Bone Marrow | 0 Participants |
| Grade 5 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Cardiac | 0 Participants |
| Grade 5 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Neurology | 0 Participants |
| Grade 5 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Hemorrhage/Bleeding | 0 Participants |
| Grade 5 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Gastrointestinal | 0 Participants |
| Grade 5 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Pain | 0 Participants |
| Grade 5 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Endocrine | 0 Participants |
| Grade 5 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Pulmonary/Upper Respiratory | 0 Participants |
| Grade 5 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Sexual/Reproductive Function | 0 Participants |
| Grade 5 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Constitutional Symptoms | 0 Participants |
| Grade 5 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Allergy/Immunology | 0 Participants |
| Grade 5 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Renal/Genitourinary | 0 Participants |
| Grade 5 CTCAE 3.0 Arm II (Placebo) | Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 | Infection | 0 Participants |
Secondary
Patients With High Expression of Transforming Growth Factor-beta 1
Time frame: Baseline to time of surgery (4 to 6 weeks)
Population: All eligible, treated and evaluable for Transforming Growth factor-beta
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm I (Levenorgestrel) | Patients With High Expression of Transforming Growth Factor-beta 1 | 6 Participants |
| Arm II (Placebo) | Patients With High Expression of Transforming Growth Factor-beta 1 | 3 Participants |
Secondary
Proportion of Proliferation as Measured by Ki-67
Time frame: Time of surgery (4 to 6 weeks after entry)
Population: All eligible, treated patients with an evaluable sample.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm I (Levenorgestrel) | Proportion of Proliferation as Measured by Ki-67 | .003 Proportion of cells exhibiting Ki-67 |
| Arm II (Placebo) | Proportion of Proliferation as Measured by Ki-67 | .008 Proportion of cells exhibiting Ki-67 |
Other Pre-specified
Median Proportion Cells That Are Apoptotic in Fallopian Tube Tissue
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)
Population: Patients with evaluable slides
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm I (Levenorgestrel) | Median Proportion Cells That Are Apoptotic in Fallopian Tube Tissue | .205 proportion of total cells |
| Arm II (Placebo) | Median Proportion Cells That Are Apoptotic in Fallopian Tube Tissue | .079 proportion of total cells |