Trial Outcomes & Findings for KEEPS Mammographic Density And Breast Health Ancillary Study (NCT NCT02524561)
NCT ID: NCT02524561
Last Updated: 2017-03-08
Results Overview
Breast density prior to randomization. Frequency of the BIRADS category according to randomization status. BIRADS is a 1-4 category of breast density as assessed by a radiologist. 1= most fatty and least dense, while 4=most dense.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
517 participants
Primary outcome timeframe
Baseline (Prior to Randomization)
Results posted on
2017-03-08
Participant Flow
Women in the parent study were approached to be part of this ancillary study (MDBHAS). For women who consented we attempted to collect their mammograms. Our collection took place after they started and were randomized in the parent study.
Participant milestones
| Measure |
CEE Pill, Active Progesterone
Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
CEE pill: Conjugated equine estrogens 0.45 mg/day
Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Placebo patch: placebo patch
|
Estradiol Patch, Active Progesterone
Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Estradiol patch: Climara 50 mcg/day
Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Placebo tablet: Placebo tablet
|
Placebo
Placebo tablet, placebo patch, placebo progesterone
Placebo tablet: Placebo tablet
Placebo patch: placebo patch
Placebo progesterone: placebo progesterone
|
|---|---|---|---|
|
Baseline: Pre-randomization Mammogram
STARTED
|
168
|
162
|
187
|
|
Baseline: Pre-randomization Mammogram
Obtained Baseline Mammogram
|
137
|
133
|
151
|
|
Baseline: Pre-randomization Mammogram
COMPLETED
|
168
|
162
|
187
|
|
Baseline: Pre-randomization Mammogram
NOT COMPLETED
|
0
|
0
|
0
|
|
Year 1: Post Randomization Mammograms
STARTED
|
168
|
162
|
187
|
|
Year 1: Post Randomization Mammograms
Obtained Mammogam
|
136
|
123
|
148
|
|
Year 1: Post Randomization Mammograms
COMPLETED
|
168
|
162
|
187
|
|
Year 1: Post Randomization Mammograms
NOT COMPLETED
|
0
|
0
|
0
|
|
Final: Year 3 or 4 Post-randomization
STARTED
|
168
|
162
|
187
|
|
Final: Year 3 or 4 Post-randomization
Obtained Year 3 or 4 Mammogram
|
143
|
139
|
151
|
|
Final: Year 3 or 4 Post-randomization
COMPLETED
|
168
|
162
|
187
|
|
Final: Year 3 or 4 Post-randomization
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
KEEPS Mammographic Density And Breast Health Ancillary Study
Baseline characteristics by cohort
| Measure |
CEE Pill, Active Progesterone
n=155 Participants
Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
CEE pill: Conjugated equine estrogens 0.45 mg/day
Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Placebo patch: placebo patch
|
Estradiol Patch, Active Progesterone
n=154 Participants
Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Estradiol patch: Climara 50 mcg/day
Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Placebo tablet: Placebo tablet
|
Placebo
n=179 Participants
Placebo tablet, placebo patch, placebo progesterone
Placebo tablet: Placebo tablet
Placebo patch: placebo patch
Placebo progesterone: placebo progesterone
|
Total
n=488 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.7 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
52.8 years
STANDARD_DEVIATION 2.5 • n=7 Participants
|
52.6 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
52.7 years
STANDARD_DEVIATION 2.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
155 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
488 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Prior to Randomization)Population: Women with mammograms are included.
Breast density prior to randomization. Frequency of the BIRADS category according to randomization status. BIRADS is a 1-4 category of breast density as assessed by a radiologist. 1= most fatty and least dense, while 4=most dense.
Outcome measures
| Measure |
CEE Pill, Active Progesterone
n=137 Participants
Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
CEE pill: Conjugated equine estrogens 0.45 mg/day
Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Placebo patch: placebo patch
|
Estradiol Patch, Active Progesterone
n=133 Participants
Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Estradiol patch: Climara 50 mcg/day
Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Placebo tablet: Placebo tablet
|
Placebo
n=151 Participants
Placebo tablet, placebo patch, placebo progesterone
Placebo tablet: Placebo tablet
Placebo patch: placebo patch
Placebo progesterone: placebo progesterone
|
|---|---|---|---|
|
BIRADS Breast Density
BIRADS 1
|
9 participants
|
9 participants
|
15 participants
|
|
BIRADS Breast Density
BIRADS 2
|
42 participants
|
48 participants
|
53 participants
|
|
BIRADS Breast Density
BIRADS 3
|
79 participants
|
65 participants
|
77 participants
|
|
BIRADS Breast Density
BIRADS 4
|
7 participants
|
11 participants
|
6 participants
|
PRIMARY outcome
Timeframe: Year 1Population: Women with mammograms 1 year after randomization
Frequency of the BIRADS category 1 year after randomization. BIRADS is a 1-4 category of breast density as assessed by a radiologist. 1= most fatty and least dense, while 4=most dense.
Outcome measures
| Measure |
CEE Pill, Active Progesterone
n=136 Participants
Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
CEE pill: Conjugated equine estrogens 0.45 mg/day
Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Placebo patch: placebo patch
|
Estradiol Patch, Active Progesterone
n=123 Participants
Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Estradiol patch: Climara 50 mcg/day
Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Placebo tablet: Placebo tablet
|
Placebo
n=148 Participants
Placebo tablet, placebo patch, placebo progesterone
Placebo tablet: Placebo tablet
Placebo patch: placebo patch
Placebo progesterone: placebo progesterone
|
|---|---|---|---|
|
BIRADS Breast Density
BIRADS 1
|
10 participants
|
9 participants
|
17 participants
|
|
BIRADS Breast Density
BIRADS 2
|
47 participants
|
44 participants
|
54 participants
|
|
BIRADS Breast Density
BIRADS 3
|
74 participants
|
67 participants
|
70 participants
|
|
BIRADS Breast Density
BIRADS 4
|
5 participants
|
3 participants
|
6 participants
|
PRIMARY outcome
Timeframe: Latest (Year 3 of 4)Population: Women with mammograms 3-4 years after randomization
Frequency of the BIRADS category 3-4 years after randomization. BIRADS is a 1-4 category of breast density as assessed by a radiologist. 1= most fatty and least dense, while 4=most dense.
Outcome measures
| Measure |
CEE Pill, Active Progesterone
n=143 Participants
Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
CEE pill: Conjugated equine estrogens 0.45 mg/day
Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Placebo patch: placebo patch
|
Estradiol Patch, Active Progesterone
n=139 Participants
Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Estradiol patch: Climara 50 mcg/day
Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Placebo tablet: Placebo tablet
|
Placebo
n=151 Participants
Placebo tablet, placebo patch, placebo progesterone
Placebo tablet: Placebo tablet
Placebo patch: placebo patch
Placebo progesterone: placebo progesterone
|
|---|---|---|---|
|
BIRADS Breast Density
BIRADS 1
|
9 participants
|
10 participants
|
18 participants
|
|
BIRADS Breast Density
BIRADS 2
|
61 participants
|
54 participants
|
70 participants
|
|
BIRADS Breast Density
BIRADS 3
|
68 participants
|
66 participants
|
55 participants
|
|
BIRADS Breast Density
BIRADS 4
|
5 participants
|
9 participants
|
8 participants
|
SECONDARY outcome
Timeframe: baseline to 3 yearsPopulation: Women with mammography reports
Abnormal mammogram requiring additional imaging modality such as MRI or ultrasound, or a breast biopsy. Information obtained from mammography reports.
Outcome measures
| Measure |
CEE Pill, Active Progesterone
n=155 Participants
Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
CEE pill: Conjugated equine estrogens 0.45 mg/day
Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Placebo patch: placebo patch
|
Estradiol Patch, Active Progesterone
n=151 Participants
Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Estradiol patch: Climara 50 mcg/day
Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Placebo tablet: Placebo tablet
|
Placebo
n=174 Participants
Placebo tablet, placebo patch, placebo progesterone
Placebo tablet: Placebo tablet
Placebo patch: placebo patch
Placebo progesterone: placebo progesterone
|
|---|---|---|---|
|
Abnormal Mammogram/Biopsy
|
50 Participants
|
63 Participants
|
55 Participants
|
Adverse Events
CEE Pill, Active Progesterone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Estradiol Patch, Active Progesterone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place