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NCT01316042 · ClinicalTrials.gov registry record · NA

Metformin for the Treatment of Premature Pubarche in Girls

A NA study, sponsored by Milton S. Hershey Medical Center.

Terminated
Registry status
NA
Development phase
4
Enrollment target

NCT01316042: Clinical Trial NA study, sponsored by Milton S. Hershey Medical Center.

NCT01316042 is a NA study that was terminated before completion, run by Milton S. Hershey Medical Center. The registered enrollment target is 4 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01316042, a NA study, was terminated before completion, sponsored by Milton S. Hershey Medical Center.

TERMINATED
Registry status
NA
Development phase
4 participants
Enrollment target

Study Summary

The primary objective of this study is to determine the safety and efficacy of metformin in lowering serum DHEAS levels in girls with premature pubarche and secondary, to observe changes in hormones associated with pubertal development including gonadotropins, sex steroids, insulin, adipocytokines, and growth factors.

Primary Outcome

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.

Interventions

  • DRUG sugar pill
  • DRUG Metformin, glucophage

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2011-05
Est. Completion 2014-04
Phase NA
Milton S. Hershey Medical Center

396 total trials

Why NCT01316042 stopped before completion

NCT01316042 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 2 interventions - of which sugar pill is the first listed.

NCT01316042 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01316042 about?

NCT01316042 is a clinical study titled "Metformin for the Treatment of Premature Pubarche in Girls". The primary objective of this study is to determine the safety and efficacy of metformin in lowering serum DHEAS levels in girls with premature pubarche and secondary, to observe changes in hormones associated with pubertal development including gonadotropins, sex steroids, insulin, adipocytokines, ...

What is the current status of trial NCT01316042?

This trial is currently terminated. It is a NA study. The enrollment target is 4 participants. The study started on 2011-05. Estimated completion is 2014-04.

What interventions are being tested in trial NCT01316042?

The interventions under investigation include: sugar pill (DRUG), Metformin, glucophage (DRUG).

Who is sponsoring clinical trial NCT01316042?

This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01316042's enrollment target sits among peer trials

4 1996th of 2000 higher than 5 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01316042, the US trial registry maintained by the National Library of Medicine. NCT01316042 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.