Trial Outcomes & Findings for Oophorectomy, Estrogen Therapy and Cardiovascular Disease Risk in Young Women (NCT NCT03815929)
NCT ID: NCT03815929
Last Updated: 2024-10-23
Results Overview
Augmented pressure, a measure of arterial stiffness was recorded through high-fidelity pressure waveforms and compared at planned time frames
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Baseline, 6 months, and 12 months
Results posted on
2024-10-23
Participant Flow
Participant milestones
| Measure |
Standard Replacement Therapy Regimen
100 mcg transdermal estradiol patch (or equivalent oral dose)
Estradiol 100 Micrograms Patch: Standard
|
Titrated Replacement Therapy Regimen
Transdermal estradiol patch (or equivalent oral dose) titrated to achieve pre-menopausal estradiol level
Estradiol Patch: Individualized
|
Timed Control Group
Healthy age-matched subjects not on hormone therapy
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
5
|
|
Overall Study
Baseline
|
15
|
15
|
5
|
|
Overall Study
6-month
|
12
|
12
|
4
|
|
Overall Study
12-month
|
11
|
12
|
4
|
|
Overall Study
COMPLETED
|
11
|
12
|
4
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
1
|
Reasons for withdrawal
| Measure |
Standard Replacement Therapy Regimen
100 mcg transdermal estradiol patch (or equivalent oral dose)
Estradiol 100 Micrograms Patch: Standard
|
Titrated Replacement Therapy Regimen
Transdermal estradiol patch (or equivalent oral dose) titrated to achieve pre-menopausal estradiol level
Estradiol Patch: Individualized
|
Timed Control Group
Healthy age-matched subjects not on hormone therapy
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
0
|
|
Overall Study
Physician Decision
|
2
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard Replacement Therapy Regimen
n=15 Participants
100 mcg transdermal estradiol patch (or equivalent oral dose)
Estradiol 100 Micrograms Patch: Standard
|
Titrated Replacement Therapy Regimen
n=15 Participants
Transdermal estradiol patch (or equivalent oral dose) titrated to achieve pre-menopausal estradiol level
Estradiol Patch: Individualized
|
Timed Control Group
n=5 Participants
Healthy age-matched subjects not on hormone therapy
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
21-45 years old
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
5 Participants
n=5 Participants
|
35 Participants
n=35 Participants
|
|
Age, Customized
>46 years old
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=35 Participants
|
|
Age, Customized
< 20 years old
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
5 Participants
n=5 Participants
|
35 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=35 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
15 participants
n=15 Participants
|
15 participants
n=15 Participants
|
5 participants
n=5 Participants
|
35 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 months, and 12 monthsAugmented pressure, a measure of arterial stiffness was recorded through high-fidelity pressure waveforms and compared at planned time frames
Outcome measures
| Measure |
Standard Replacement Therapy Regimen
n=10 Participants
100 mcg transdermal estradiol patch (or equivalent oral dose)
Estradiol 100 Micrograms Patch: Standard
|
Titrated Replacement Therapy Regimen
n=12 Participants
Transdermal estradiol patch (or equivalent oral dose) titrated to achieve pre-menopausal estradiol level
Estradiol Patch: Individualized
|
Timed Control Group
n=4 Participants
Healthy age-matched subjects not on hormone therapy
|
|---|---|---|---|
|
Arterial Stiffness
Baseline augmented pressure
|
10.1 mm Hg
Standard Deviation 6.9
|
14.8 mm Hg
Standard Deviation 4.3
|
6.4 mm Hg
Standard Deviation 3.7
|
|
Arterial Stiffness
6 months augmented pressure
|
12.7 mm Hg
Standard Deviation 6.0
|
16.8 mm Hg
Standard Deviation 6.4
|
5.1 mm Hg
Standard Deviation 3.1
|
|
Arterial Stiffness
12 months augmented pressure
|
12.9 mm Hg
Standard Deviation 6.7
|
17.3 mm Hg
Standard Deviation 7.2
|
6.5 mm Hg
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: Baseline, 6 months, and 12 monthsChange in mean blood pressure in response to isometric hand grip exercise (30% maximum voluntary contraction)
Outcome measures
| Measure |
Standard Replacement Therapy Regimen
n=9 Participants
100 mcg transdermal estradiol patch (or equivalent oral dose)
Estradiol 100 Micrograms Patch: Standard
|
Titrated Replacement Therapy Regimen
n=11 Participants
Transdermal estradiol patch (or equivalent oral dose) titrated to achieve pre-menopausal estradiol level
Estradiol Patch: Individualized
|
Timed Control Group
n=4 Participants
Healthy age-matched subjects not on hormone therapy
|
|---|---|---|---|
|
Mean Blood Pressure Reactivity to Isometric Hand Grip Exercise
6-month mean blood pressure reactivity
|
11.7 mm Hg
Standard Deviation 5.0
|
15.3 mm Hg
Standard Deviation 5.3
|
10.7 mm Hg
Standard Deviation 2.6
|
|
Mean Blood Pressure Reactivity to Isometric Hand Grip Exercise
12-month mean blood pressure reactivity
|
16.2 mm Hg
Standard Deviation 7.1
|
12.4 mm Hg
Standard Deviation 7.6
|
13.9 mm Hg
Standard Deviation 9.9
|
|
Mean Blood Pressure Reactivity to Isometric Hand Grip Exercise
baseline mean blood pressure reactivity
|
11.6 mm Hg
Standard Deviation 4.6
|
11.4 mm Hg
Standard Deviation 5.9
|
8.3 mm Hg
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Baseline, 6 months, and 12 monthsMaximum change in mean blood pressure during 3-minute cold pressor test (immersing hand up to wrist in ice water while changes in blood pressure monitored)
Outcome measures
| Measure |
Standard Replacement Therapy Regimen
n=8 Participants
100 mcg transdermal estradiol patch (or equivalent oral dose)
Estradiol 100 Micrograms Patch: Standard
|
Titrated Replacement Therapy Regimen
n=10 Participants
Transdermal estradiol patch (or equivalent oral dose) titrated to achieve pre-menopausal estradiol level
Estradiol Patch: Individualized
|
Timed Control Group
n=4 Participants
Healthy age-matched subjects not on hormone therapy
|
|---|---|---|---|
|
Mean Blood Pressure Reactivity to Cold Stress
Baseline mean blood pressure reactivity
|
22 mm Hg
Standard Deviation 10
|
20 mm Hg
Standard Deviation 9
|
20 mm Hg
Standard Deviation 8
|
|
Mean Blood Pressure Reactivity to Cold Stress
6-month mean blood pressure reactivity
|
21 mm Hg
Standard Deviation 13
|
25 mm Hg
Standard Deviation 9
|
18 mm Hg
Standard Deviation 5
|
|
Mean Blood Pressure Reactivity to Cold Stress
12-month mean blood pressure reactivity
|
26 mm Hg
Standard Deviation 12
|
25 mm Hg
Standard Deviation 7
|
17 mm Hg
Standard Deviation 3
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsMeasurements of whole-body fat using Dual energy x-ray absorptiometry (DXA)
Outcome measures
| Measure |
Standard Replacement Therapy Regimen
n=10 Participants
100 mcg transdermal estradiol patch (or equivalent oral dose)
Estradiol 100 Micrograms Patch: Standard
|
Titrated Replacement Therapy Regimen
n=15 Participants
Transdermal estradiol patch (or equivalent oral dose) titrated to achieve pre-menopausal estradiol level
Estradiol Patch: Individualized
|
Timed Control Group
n=4 Participants
Healthy age-matched subjects not on hormone therapy
|
|---|---|---|---|
|
Changes in Whole Body Fat
Baseline total body fat
|
30712 gm
Standard Deviation 12958
|
43363 gm
Standard Deviation 26212
|
199936 gm
Standard Deviation 14221
|
|
Changes in Whole Body Fat
12-month total body fat
|
31868 gm
Standard Deviation 18020
|
42660 gm
Standard Deviation 25938
|
16735 gm
Standard Deviation 3114
|
Adverse Events
Standard Replacement Therapy Regimen
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Titrated Replacement Therapy Regimen
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Timed Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Replacement Therapy Regimen
n=15 participants at risk
100 mcg transdermal estradiol patch (or equivalent oral dose)
Estradiol 100 Micrograms Patch: Standard
|
Titrated Replacement Therapy Regimen
n=15 participants at risk
Transdermal estradiol patch (or equivalent oral dose) titrated to achieve pre-menopausal estradiol level
Estradiol Patch: Individualized
|
Timed Control Group
n=5 participants at risk
Healthy age-matched subjects not on hormone therapy
|
|---|---|---|---|
|
Gastrointestinal disorders
Intestinal obstruction
|
6.7%
1/15 • Number of events 1 • 12 months
|
0.00%
0/15 • 12 months
|
0.00%
0/5 • 12 months
|
|
Cardiac disorders
Sinus tachycardia of unknown etiology after planned oophorectomy & liver procedure
|
6.7%
1/15 • Number of events 1 • 12 months
|
0.00%
0/15 • 12 months
|
0.00%
0/5 • 12 months
|
|
General disorders
Liver Infarct (extended hospital stay)
|
0.00%
0/15 • 12 months
|
6.7%
1/15 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
|
General disorders
non-focal Bile leak from disease resection (extended hospital stay)
|
0.00%
0/15 • 12 months
|
6.7%
1/15 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
Other adverse events
| Measure |
Standard Replacement Therapy Regimen
n=15 participants at risk
100 mcg transdermal estradiol patch (or equivalent oral dose)
Estradiol 100 Micrograms Patch: Standard
|
Titrated Replacement Therapy Regimen
n=15 participants at risk
Transdermal estradiol patch (or equivalent oral dose) titrated to achieve pre-menopausal estradiol level
Estradiol Patch: Individualized
|
Timed Control Group
n=5 participants at risk
Healthy age-matched subjects not on hormone therapy
|
|---|---|---|---|
|
General disorders
Rash at patch site
|
6.7%
1/15 • Number of events 1 • 12 months
|
6.7%
1/15 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
|
General disorders
Passed out after blood draw at CRTU
|
0.00%
0/15 • 12 months
|
6.7%
1/15 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
|
General disorders
Moderate bilateral pleural effusion
|
0.00%
0/15 • 12 months
|
6.7%
1/15 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
|
General disorders
Ovarian Cancer Stage IIIc high grade Serious Carcinoma
|
0.00%
0/15 • 12 months
|
6.7%
1/15 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
|
General disorders
COVID 19
|
0.00%
0/15 • 12 months
|
6.7%
1/15 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
|
General disorders
Decreased Libido
|
0.00%
0/15 • 12 months
|
6.7%
1/15 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
|
General disorders
Bladder Issues
|
0.00%
0/15 • 12 months
|
6.7%
1/15 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
|
General disorders
Headache/vomitting/allergic reaction to MRI
|
0.00%
0/15 • 12 months
|
6.7%
1/15 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
|
Reproductive system and breast disorders
Vaginal cuff dehiscence
|
0.00%
0/15 • 12 months
|
6.7%
1/15 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
|
Reproductive system and breast disorders
Pain with intercourse, vaginal dryness, and low sex drive
|
0.00%
0/15 • 12 months
|
6.7%
1/15 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
|
General disorders
Migraine with vomitting during blood pressure regulation baseline testing
|
6.7%
1/15 • Number of events 1 • 12 months
|
0.00%
0/15 • 12 months
|
0.00%
0/5 • 12 months
|
|
General disorders
Itching from patch site
|
6.7%
1/15 • Number of events 1 • 12 months
|
0.00%
0/15 • 12 months
|
0.00%
0/5 • 12 months
|
|
Reproductive system and breast disorders
Vaginal cuff dehiscence with infection
|
0.00%
0/15 • 12 months
|
6.7%
1/15 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
|
General disorders
Estradiol gives burnt taste in mouth
|
0.00%
0/15 • 12 months
|
6.7%
1/15 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place