Trial Outcomes & Findings for Levonorgestrel in Preventing Ovarian Cancer in Patients at High Risk for Ovarian Cancer (NCT NCT00445887)
NCT ID: NCT00445887
Last Updated: 2019-11-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Surgical specimen (4 - 6 weeks after entry)
Results posted on
2019-11-19
Participant Flow
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.
Participant milestones
| Measure |
Arm I (Levenorgestrel)
Levenorgestrel (0.15 mg/day) for 4 to 6 weeks for 4 to 6 weeks
|
Arm II (Placebo)
Placebo for 4 to 6 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
31
|
|
Overall Study
COMPLETED
|
33
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Levonorgestrel in Preventing Ovarian Cancer in Patients at High Risk for Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Levenorgestrel)
n=33 Participants
Levenorgestrel (0.15 mg/day) for 4 to 6 weeks for 4 to 6 weeks
|
Arm II (Placebo)
n=31 Participants
Placebo for 4 to 6 weeks
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
20-29 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Customized
30-39 years
|
4 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Age, Customized
40-49 years
|
14 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Age, Customized
50-59 years
|
14 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Age, Customized
60-69 years
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
64 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Arm I (Levenorgestrel)
n=26 Participants
Levenorgestrel (0.15 mg/day) for 4 to 6 weeks for 4 to 6 weeks
|
Arm II (Placebo)
n=24 Participants
Placebo for 4 to 6 weeks
|
Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel)
Number of patients on arm 1 who experienced a grade 3 event using CTCAE v 3.0
|
Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel)
Number of patients on arm ! who experienced a grade 4 event using CTCAE v. 3.0
|
Grade 5 CTCAE v3.0 Arm I (Levonorgestrel)
Number of patients on arm I who experienced a grade 5 event using CTCAE v. 3.0
|
Grade 1 CTCAE 3.0 Arm II (Placebo)
Number of patients on arm II who experienced a grade 1 event using CTCAE v.30
|
Grade 2 CTCAE 3.0 Arm II (Placebo)
Number of patients on arm II who experienced a grade 2 event using CTCAE 3.0
|
Grade 3 CTCAE 3.0 Arm II (Placebo)
Number of patients on arm II who experienced a grade 3 event using CTCAE 3.0
|
Grade 4 CTCAE 3.0 Arm II (Placebo)
Number of patients on arm II who experienced a grade 4 event using CTCAE 3.0
|
Grade 5 CTCAE 3.0 Arm II (Placebo)
Number of patients on arm II who experienced a grade 5 event using CTCAE 3.0
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Median Proportion Cells That Are Apoptotic in Epithelial Ovarian Tissue
|
.093 proportion of total cells
Interval 0.024 to 0.25
|
.115 proportion of total cells
Interval 0.033 to 0.329
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 20 weeksPopulation: All eligible and treated patients who had toxicity on study.
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.
Outcome measures
| Measure |
Arm I (Levenorgestrel)
n=33 Participants
Levenorgestrel (0.15 mg/day) for 4 to 6 weeks for 4 to 6 weeks
|
Arm II (Placebo)
n=33 Participants
Placebo for 4 to 6 weeks
|
Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel)
n=33 Participants
Number of patients on arm 1 who experienced a grade 3 event using CTCAE v 3.0
|
Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel)
n=33 Participants
Number of patients on arm ! who experienced a grade 4 event using CTCAE v. 3.0
|
Grade 5 CTCAE v3.0 Arm I (Levonorgestrel)
n=33 Participants
Number of patients on arm I who experienced a grade 5 event using CTCAE v. 3.0
|
Grade 1 CTCAE 3.0 Arm II (Placebo)
n=31 Participants
Number of patients on arm II who experienced a grade 1 event using CTCAE v.30
|
Grade 2 CTCAE 3.0 Arm II (Placebo)
n=31 Participants
Number of patients on arm II who experienced a grade 2 event using CTCAE 3.0
|
Grade 3 CTCAE 3.0 Arm II (Placebo)
n=31 Participants
Number of patients on arm II who experienced a grade 3 event using CTCAE 3.0
|
Grade 4 CTCAE 3.0 Arm II (Placebo)
n=31 Participants
Number of patients on arm II who experienced a grade 4 event using CTCAE 3.0
|
Grade 5 CTCAE 3.0 Arm II (Placebo)
n=31 Participants
Number of patients on arm II who experienced a grade 5 event using CTCAE 3.0
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0
Pain
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0
Allergy/Immunology
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0
Constitutional Symptoms
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0
Cardiac
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0
Dermatology/Skin
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0
Endocrine
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0
Gastrointestinal
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0
Renal/Genitourinary
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0
Hemorrhage/Bleeding
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0
Blood/Bone Marrow
|
5 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0
Infection
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0
Metabolic/Laboratory
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0
Neurology
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0
Pulmonary/Upper Respiratory
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0
Sexual/Reproductive Function
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Time of surgery (4 to 6 weeks after entry)Population: All eligible, treated patients with an evaluable sample.
Outcome measures
| Measure |
Arm I (Levenorgestrel)
n=32 Participants
Levenorgestrel (0.15 mg/day) for 4 to 6 weeks for 4 to 6 weeks
|
Arm II (Placebo)
n=30 Participants
Placebo for 4 to 6 weeks
|
Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel)
Number of patients on arm 1 who experienced a grade 3 event using CTCAE v 3.0
|
Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel)
Number of patients on arm ! who experienced a grade 4 event using CTCAE v. 3.0
|
Grade 5 CTCAE v3.0 Arm I (Levonorgestrel)
Number of patients on arm I who experienced a grade 5 event using CTCAE v. 3.0
|
Grade 1 CTCAE 3.0 Arm II (Placebo)
Number of patients on arm II who experienced a grade 1 event using CTCAE v.30
|
Grade 2 CTCAE 3.0 Arm II (Placebo)
Number of patients on arm II who experienced a grade 2 event using CTCAE 3.0
|
Grade 3 CTCAE 3.0 Arm II (Placebo)
Number of patients on arm II who experienced a grade 3 event using CTCAE 3.0
|
Grade 4 CTCAE 3.0 Arm II (Placebo)
Number of patients on arm II who experienced a grade 4 event using CTCAE 3.0
|
Grade 5 CTCAE 3.0 Arm II (Placebo)
Number of patients on arm II who experienced a grade 5 event using CTCAE 3.0
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Proliferation as Measured by Ki-67
|
.003 Proportion of cells exhibiting Ki-67
Interval 0.0 to 0.008
|
.008 Proportion of cells exhibiting Ki-67
Interval 0.002 to 0.028
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to time of surgery (4 to 6 weeks)Population: All eligible, treated and evaluable for Transforming Growth factor-beta
Outcome measures
| Measure |
Arm I (Levenorgestrel)
n=29 Participants
Levenorgestrel (0.15 mg/day) for 4 to 6 weeks for 4 to 6 weeks
|
Arm II (Placebo)
n=20 Participants
Placebo for 4 to 6 weeks
|
Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel)
Number of patients on arm 1 who experienced a grade 3 event using CTCAE v 3.0
|
Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel)
Number of patients on arm ! who experienced a grade 4 event using CTCAE v. 3.0
|
Grade 5 CTCAE v3.0 Arm I (Levonorgestrel)
Number of patients on arm I who experienced a grade 5 event using CTCAE v. 3.0
|
Grade 1 CTCAE 3.0 Arm II (Placebo)
Number of patients on arm II who experienced a grade 1 event using CTCAE v.30
|
Grade 2 CTCAE 3.0 Arm II (Placebo)
Number of patients on arm II who experienced a grade 2 event using CTCAE 3.0
|
Grade 3 CTCAE 3.0 Arm II (Placebo)
Number of patients on arm II who experienced a grade 3 event using CTCAE 3.0
|
Grade 4 CTCAE 3.0 Arm II (Placebo)
Number of patients on arm II who experienced a grade 4 event using CTCAE 3.0
|
Grade 5 CTCAE 3.0 Arm II (Placebo)
Number of patients on arm II who experienced a grade 5 event using CTCAE 3.0
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Patients With High Expression of Transforming Growth Factor-beta 1
|
6 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Surgical specimen (4-6 weeks after entry)Population: Patients with evaluable slides
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
Outcome measures
| Measure |
Arm I (Levenorgestrel)
n=32 Participants
Levenorgestrel (0.15 mg/day) for 4 to 6 weeks for 4 to 6 weeks
|
Arm II (Placebo)
n=30 Participants
Placebo for 4 to 6 weeks
|
Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel)
Number of patients on arm 1 who experienced a grade 3 event using CTCAE v 3.0
|
Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel)
Number of patients on arm ! who experienced a grade 4 event using CTCAE v. 3.0
|
Grade 5 CTCAE v3.0 Arm I (Levonorgestrel)
Number of patients on arm I who experienced a grade 5 event using CTCAE v. 3.0
|
Grade 1 CTCAE 3.0 Arm II (Placebo)
Number of patients on arm II who experienced a grade 1 event using CTCAE v.30
|
Grade 2 CTCAE 3.0 Arm II (Placebo)
Number of patients on arm II who experienced a grade 2 event using CTCAE 3.0
|
Grade 3 CTCAE 3.0 Arm II (Placebo)
Number of patients on arm II who experienced a grade 3 event using CTCAE 3.0
|
Grade 4 CTCAE 3.0 Arm II (Placebo)
Number of patients on arm II who experienced a grade 4 event using CTCAE 3.0
|
Grade 5 CTCAE 3.0 Arm II (Placebo)
Number of patients on arm II who experienced a grade 5 event using CTCAE 3.0
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Median Proportion Cells That Are Apoptotic in Fallopian Tube Tissue
|
.205 proportion of total cells
Interval 0.07 to 0.395
|
.079 proportion of total cells
Interval 0.01 to 0.25
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Arm I (Levenorgestrel)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Arm II (Placebo)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (Levenorgestrel)
n=33 participants at risk
Levenorgestrel (0.15 mg/day) for 4 to 6 weeks for 4 to 6 weeks
|
Arm II (Placebo)
n=31 participants at risk
Placebo for 4 to 6 weeks
|
|---|---|---|
|
Immune system disorders
Allergy/Immunology - Other
|
3.0%
1/33 • Study Treatment - 4 - 6 weeks from enrollment
|
0.00%
0/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
Immune system disorders
Rhinitis
|
0.00%
0/33 • Study Treatment - 4 - 6 weeks from enrollment
|
3.2%
1/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
Blood and lymphatic system disorders
Neutrophils
|
3.0%
1/33 • Study Treatment - 4 - 6 weeks from enrollment
|
0.00%
0/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other
|
0.00%
0/33 • Study Treatment - 4 - 6 weeks from enrollment
|
3.2%
1/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
Blood and lymphatic system disorders
Leukocytes
|
0.00%
0/33 • Study Treatment - 4 - 6 weeks from enrollment
|
6.5%
2/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
Blood and lymphatic system disorders
Hemoglobin
|
18.2%
6/33 • Study Treatment - 4 - 6 weeks from enrollment
|
9.7%
3/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
Cardiac disorders
Hypertension
|
3.0%
1/33 • Study Treatment - 4 - 6 weeks from enrollment
|
0.00%
0/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
General disorders
Sweating
|
3.0%
1/33 • Study Treatment - 4 - 6 weeks from enrollment
|
0.00%
0/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
General disorders
Fever
|
0.00%
0/33 • Study Treatment - 4 - 6 weeks from enrollment
|
3.2%
1/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
Skin and subcutaneous tissue disorders
Acne
|
6.1%
2/33 • Study Treatment - 4 - 6 weeks from enrollment
|
0.00%
0/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
0.00%
0/33 • Study Treatment - 4 - 6 weeks from enrollment
|
3.2%
1/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
Endocrine disorders
Hot Flashes
|
3.0%
1/33 • Study Treatment - 4 - 6 weeks from enrollment
|
6.5%
2/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/33 • Study Treatment - 4 - 6 weeks from enrollment
|
3.2%
1/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/33 • Study Treatment - 4 - 6 weeks from enrollment
|
3.2%
1/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
Gastrointestinal disorders
Distention
|
0.00%
0/33 • Study Treatment - 4 - 6 weeks from enrollment
|
3.2%
1/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
Gastrointestinal disorders
Constipation
|
3.0%
1/33 • Study Treatment - 4 - 6 weeks from enrollment
|
0.00%
0/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
Vascular disorders
Hemorrhage, Gu - Vagina
|
9.1%
3/33 • Study Treatment - 4 - 6 weeks from enrollment
|
3.2%
1/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
Infections and infestations
Infection - Other
|
3.0%
1/33 • Study Treatment - 4 - 6 weeks from enrollment
|
0.00%
0/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
Infections and infestations
Inf Unknown Anc: Bronchus
|
0.00%
0/33 • Study Treatment - 4 - 6 weeks from enrollment
|
3.2%
1/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
Infections and infestations
Inf Unknown Anc: Urinary Tract Nos
|
3.0%
1/33 • Study Treatment - 4 - 6 weeks from enrollment
|
0.00%
0/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
Infections and infestations
Inf Unknown Anc: Colon
|
3.0%
1/33 • Study Treatment - 4 - 6 weeks from enrollment
|
0.00%
0/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.0%
1/33 • Study Treatment - 4 - 6 weeks from enrollment
|
3.2%
1/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.0%
1/33 • Study Treatment - 4 - 6 weeks from enrollment
|
0.00%
0/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/33 • Study Treatment - 4 - 6 weeks from enrollment
|
3.2%
1/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
Nervous system disorders
Dizziness
|
0.00%
0/33 • Study Treatment - 4 - 6 weeks from enrollment
|
3.2%
1/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
General disorders
Pain: Chest /Thorax Nos
|
3.0%
1/33 • Study Treatment - 4 - 6 weeks from enrollment
|
0.00%
0/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
General disorders
Pain: Head/Headache
|
6.1%
2/33 • Study Treatment - 4 - 6 weeks from enrollment
|
6.5%
2/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
General disorders
Pain: Back
|
0.00%
0/33 • Study Treatment - 4 - 6 weeks from enrollment
|
3.2%
1/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
General disorders
Pain: Bladder
|
3.0%
1/33 • Study Treatment - 4 - 6 weeks from enrollment
|
0.00%
0/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
General disorders
Pain: Abdominal Pain Nos
|
3.0%
1/33 • Study Treatment - 4 - 6 weeks from enrollment
|
3.2%
1/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.0%
1/33 • Study Treatment - 4 - 6 weeks from enrollment
|
0.00%
0/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
Renal and urinary disorders
Urinary Retention
|
3.0%
1/33 • Study Treatment - 4 - 6 weeks from enrollment
|
0.00%
0/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
Renal and urinary disorders
Urinary Frequency
|
3.0%
1/33 • Study Treatment - 4 - 6 weeks from enrollment
|
0.00%
0/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
Reproductive system and breast disorders
Sexual/Reproductive Function: Other
|
3.0%
1/33 • Study Treatment - 4 - 6 weeks from enrollment
|
3.2%
1/31 • Study Treatment - 4 - 6 weeks from enrollment
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
6.1%
2/33 • Study Treatment - 4 - 6 weeks from enrollment
|
0.00%
0/31 • Study Treatment - 4 - 6 weeks from enrollment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place