Trial Outcomes & Findings for Comparison of Transdermal and Oral Estrogens in Adolescent Girls With Ovarian Failure (NCT NCT01023178)
NCT ID: NCT01023178
Last Updated: 2017-01-20
Results Overview
Estradiol blood levels at end of study compared across groups to determine effect of dosing methods. Significance of levels depends on the stage of puberty and goals of therapy.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
end of study (up to 2 years)
Results posted on
2017-01-20
Participant Flow
from 2007-2011 study participants were recruited from pediatric endocrinology clinics at Lucile Packard Children's Hospital at Stanford.
Participant milestones
| Measure |
Transdermal 17Beta Estradiol
17Beta Estradiol - transdermal: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months
Progesterone, micronized: Given starting at 18 months
|
Oral Conjugated Equine Estrogen
Conjugated estrogens: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months
Progesterone, micronized: Given starting at 18 months
|
Oral 17beta Estradiol
17beta Estradiol: Oral pill given daily at increasing doses every 6 months for 18 months.
Progesterone, micronized: Given starting at 18 months
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
8
|
7
|
|
Overall Study
COMPLETED
|
3
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Transdermal and Oral Estrogens in Adolescent Girls With Ovarian Failure
Baseline characteristics by cohort
| Measure |
Transdermal 17Beta Estradiol
n=5 Participants
17Beta Estradiol - transdermal: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months
Progesterone, micronized: Given starting at 18 months
|
Oral Conjugated Equine Estrogen
n=8 Participants
Conjugated estrogens: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months
Progesterone, micronized: Given starting at 18 months
|
Oral 17beta Estradiol
n=7 Participants
17beta Estradiol: Oral pill given daily at increasing doses every 6 months for 18 months.
Progesterone, micronized: Given starting at 18 months
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
14.2 years
STANDARD_DEVIATION 0.5 • n=5 Participants
|
13.8 years
STANDARD_DEVIATION 0.4 • n=7 Participants
|
14.5 years
STANDARD_DEVIATION 0.6 • n=5 Participants
|
14.2 years
STANDARD_DEVIATION 0.6 • n=4 Participants
|
|
Sex/Gender, Customized
Female
|
5 participants
n=5 Participants
|
8 participants
n=7 Participants
|
7 participants
n=5 Participants
|
20 participants
n=4 Participants
|
|
Follicle Stimulating Hormone (FSH)
|
76 mIU/mL
n=5 Participants
|
86 mIU/mL
n=7 Participants
|
71 mIU/mL
n=5 Participants
|
78 mIU/mL
n=4 Participants
|
|
Luteinizing Hormone (LH)
|
14 mIU/mL
n=5 Participants
|
26 mIU/mL
n=7 Participants
|
13 mIU/mL
n=5 Participants
|
18 mIU/mL
n=4 Participants
|
PRIMARY outcome
Timeframe: end of study (up to 2 years)Estradiol blood levels at end of study compared across groups to determine effect of dosing methods. Significance of levels depends on the stage of puberty and goals of therapy.
Outcome measures
| Measure |
Transdermal 17Beta Estradiol
n=3 Participants
17Beta Estradiol - transdermal: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months
Progesterone, micronized: Given starting at 18 months
|
Oral Conjugated Equine Estrogen
n=6 Participants
Conjugated estrogens: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months
Progesterone, micronized: Given starting at 18 months
|
Oral 17beta Estradiol
n=4 Participants
17beta Estradiol: Oral pill given daily at increasing doses every 6 months for 18 months.
Progesterone, micronized: Given starting at 18 months
|
|---|---|---|---|
|
Estradiol
|
53 pg/mL
Standard Error 19
|
14 pg/mL
Standard Error 5
|
12 pg/mL
Standard Error 5
|
Adverse Events
Transdermal 17Beta Estradiol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Oral Conjugated Equine Estrogen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Oral 17beta Estradiol
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