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Trial Outcomes & Findings for Metformin for the Treatment of Premature Pubarche in Girls (NCT NCT01316042)

NCT ID: NCT01316042

Last Updated: 2016-05-12

Results Overview

Change in DHEAS level was constructed per subject as the 1-year measurement minus the baseline measurement. Only descriptive statistics are provided, statistical tests were not conducted given the extremely small sample size per group.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

1 year

Results posted on

2016-05-12

Participant Flow

Participant milestones

Participant milestones
Measure
Sugar Pill
2 pills per day for 12 months
Metformin
2 212.5mg pill/day for 12 months
Overall Study
STARTED
2
2
Overall Study
COMPLETED
2
1
Overall Study
NOT COMPLETED
0
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Metformin for the Treatment of Premature Pubarche in Girls

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Sugar Pill
n=2 Participants
2 pills per day for 12 months
Metformin
n=2 Participants
2 212.5mg pill/day for 12 months
Total
n=4 Participants
Total of all reporting groups
Age, Continuous
7.5 years
n=93 Participants
6 years
n=4 Participants
6.75 years
n=27 Participants
Sex: Female, Male
Female
2 Participants
n=93 Participants
2 Participants
n=4 Participants
4 Participants
n=27 Participants
Sex: Female, Male
Male
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
DHEAS
177.0 ug/dL
n=93 Participants
67.6 ug/dL
n=4 Participants
122.3 ug/dL
n=27 Participants

PRIMARY outcome

Timeframe: 1 year

Change in DHEAS level was constructed per subject as the 1-year measurement minus the baseline measurement. Only descriptive statistics are provided, statistical tests were not conducted given the extremely small sample size per group.

Outcome measures

Outcome measures
Measure
Sugar Pill
n=2 Participants
2 pills per day for 12 months
Metformin
n=1 Participants
2 212.5mg pill/day for 12 months
Change in Serum DHEAS Levels
10.25 ug/dL
Interval -11.0 to 31.5
4.8 ug/dL
Interval 4.8 to 4.8

Adverse Events

Sugar Pill

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Metformin

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Sugar Pill
n=2 participants at risk
2 pills per day for 12 months
Metformin
n=2 participants at risk
2 212.5mg pill/day for 12 months
Infections and infestations
Ear infection
50.0%
1/2 • Number of events 1 • 1 year
0.00%
0/2 • 1 year
Infections and infestations
Pink eye
0.00%
0/2 • 1 year
50.0%
1/2 • Number of events 1 • 1 year

Additional Information

Richard S. Legro, M.D.

Milton S. Hershey Medical Center

Phone: 717-531-8478

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place