Trials / Terminated
TerminatedNCT01316042
Metformin for the Treatment of Premature Pubarche in Girls
A Double Blind Randomized Controlled 12 Month Trial of Metformin for the Treatment of Premature Pubarche in Girls
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- Milton S. Hershey Medical Center · Academic / Other
- Sex
- Female
- Age
- 4 Years – 10 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | sugar pill | 2 pills per day for 12 months |
| DRUG | Metformin, glucophage | 2 212.5mg pills/day for 12 months |
Timeline
- Start date
- 2011-05-01
- Primary completion
- 2013-12-01
- Completion
- 2014-04-01
- First posted
- 2011-03-16
- Last updated
- 2016-05-12
- Results posted
- 2016-05-12
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01316042. Inclusion in this directory is not an endorsement.