Metformin for the Treatment of Premature Pubarche in Girls

NCT01316042 | Terminated Results DMC

• 1 other identifier: 35865
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 3

Brief 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

Premature Pubarche

Keywords

Puberty; Hormones

Outcome Measures

Primary Outcomes (1)

• Change in Serum DHEAS Levels

  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.

  1 year

Study Arms (2)

sugar pill

PLACEBO COMPARATOR

2 pills per day for 12 months

Drug: sugar pill

Metformin

ACTIVE COMPARATOR

2 212.5mg pill/day for 12 months

Drug: Metformin, glucophage

Interventions

sugar pill DRUG

2 pills per day for 12 months

sugar pill

Metformin, glucophage DRUG

2 212.5mg pills/day for 12 months

Also known as: metformin

Metformin

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Girls aged 4-10 with pubic hair prior to 8 years of age
• Elevated DHEAS level above age normal levels
• Informed consent from parents and assent from the girl

You may not qualify if:

• Diagnosis of incomplete precocious puberty, peripheral precocious puberty, or evidence of any abnormal pituitary, hypothalamic, adrenal, thyroid, and gonadal function other than premature secretion of adrenal androgens.
• Chronic illness requiring treatment that may interfere with growth and development, i.e. chronic steroid use, renal failure, etc.
• Uncorrected thyroid disease (defined as TSH \< 0.2 mIU/ML or \> 5.5 mIU/mL). A normal level within the last year is adequate for entry.
• Type I or Type II diabetes (defined as a fasting serum glucose \> 125mg/dL on two occasions 83), or patients receiving anti-diabetic medications such as insulin, thiazolidinediones, acarbose, or sulfonylureas; patients currently receiving metformin XR for a diagnosis of Type I or Type II diabetes or for PCOS are also specifically excluded.
• Liver disease defined as AST or ALT \> 2 times normal or total bilirubin \> 2.5 mg/dL.
• Renal disease defined as BUN \> 30 mg/dL or serum creatinine \> 1.4 mg/dL.
• Significant anemia (Hemoglobin \< 10 mg/dL).
• History of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident.
• Known heart disease (New York Heart Association Class II or higher).
• Enrolled simultaneously into other investigative studies that require medications, proscribe the study medications, or otherwise prevent compliance with the protocol. Patients who anticipate taking longer than a one month break during the protocol should not be enrolled.
• Concomitant use other medications known to affect reproductive function or metabolism. These medications include growth hormone, IGF-1, medroxyprogesterone acetate, oral contraceptives, GnRH agonists and antagonists, anti-androgens, gonadotropins, anti-obesity drugs, somatostatin, diazoxide, ACE inhibitors, and calcium channel blockers. The washout period on all these medications will be three months.
• Suspected adrenal or ovarian tumor secreting androgens or other ectopic steroid secreting tumor.
• Suspected Cushing's syndrome.
• Lactose intolerance (the placebo filler is lactose).
• Known hypersensitivity to study medication, including ACTH and GnRH, or their excipients.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (3)

Riley Hospital for Children, Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Children's Hospital of Pittsburgh at the University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Interventions

Sugars; Metformin

Intervention Hierarchy (Ancestors)

Carbohydrates; Biguanides; Guanidines; Amidines; Organic Chemicals

Limitations and Caveats

Early termination of the study due to low recruitment.

Results Point of Contact

• Title: Richard S. Legro, M.D.
• Organization: Milton S. Hershey Medical Center

rlegro@hmc.psu.edu

717-531-8478

Study Officials

• Richard S Legro, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Obstetrics and Gynecology and Public Health Sciences

Study Record Dates

• First Submitted: March 15, 2011
• First Posted: March 16, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: April 1, 2014
• Last Updated: May 12, 2016
• Results First Posted: May 12, 2016

Record last verified: 2016-04

Locations

US (3)