Trial Outcomes & Findings for Investigation of Female Reproductive Hormone Dynamics During Adolescence (NCT NCT02486757)
NCT ID: NCT02486757
Last Updated: 2018-12-24
Results Overview
serum progesterone \> 3 ng/ml or presence of corpus luteum on pelvic ultrasound
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
9 participants
Primary outcome timeframe
20-40 days
Results posted on
2018-12-24
Participant Flow
Participant milestones
| Measure |
Interventional
estradiol 50 mcg transdermal patch x 7 days oral micronized progesterone 0.5 mg/kg/dose TID x 7 days
micronized progesterone
transdermal estradiol
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Interventional
estradiol 50 mcg transdermal patch x 7 days oral micronized progesterone 0.5 mg/kg/dose TID x 7 days
micronized progesterone
transdermal estradiol
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Investigation of Female Reproductive Hormone Dynamics During Adolescence
Baseline characteristics by cohort
| Measure |
Interventional
n=6 Participants
estradiol 50 mcg transdermal patch x 7 days oral micronized progesterone 0.5 mg/kg/dose TID x 7 days
micronized progesterone
transdermal estradiol
|
|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
14.9 years
STANDARD_DEVIATION 1.5 • n=93 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 20-40 daysPopulation: subjects with sufficient data in cycle to determine ovulatory/anovulatory status
serum progesterone \> 3 ng/ml or presence of corpus luteum on pelvic ultrasound
Outcome measures
| Measure |
Interventional
n=5 Participants
estradiol 50 mcg transdermal patch x 7 days oral micronized progesterone 0.5 mg/kg/dose TID x 7 days
micronized progesterone
transdermal estradiol
|
|---|---|
|
Ovulation in Cycle 2
ovulatory
|
3 Participants
|
|
Ovulation in Cycle 2
anovulatory
|
2 Participants
|
Adverse Events
Interventional
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