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Testolactone for the Treatment of Girls With LHRH Resistant Precocious Puberty

NCT00001181 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2008-03-04

No results posted yet for this study

Summary

The normal changes of puberty, such as breast enlargement, pubic hair and menstrual periods, usually begin between the ages of 9 and 15 in response to hormones produced in the body. Some children's bodies produce these hormones before the normal age and start puberty too early. This condition is known as precocious puberty.

The hormones responsible for the onset of puberty come from the pituitary gland and the ovaries. The hormones from the pituitary gland act on the ovaries to produce different hormones that cause the breasts to grow, pubic hair to develop, and menstruation.

Many children with precocious puberty can be treated with a medication known as lutenizing hormone-releasing hormone analog (Lupron, Histerelin, Deslorelin). This drug is made in a laboratory and is designed to act like the natural hormone LHRH, which is made in the pituitary gland. The drug causes the pituitary gland to decrease the amount of hormones it is releasing and thereby decrease the amount of hormones released by the ovaries. However, some girls already have low levels of pituitary hormones and yet their ovaries still produce hormones. Researchers do not believe that LHRH analog therapy will work for these children.

Testolactone is a drug that acts directly on the ovary. It works by preventing the last step of estrogen production in the ovary. The goal of this treatment is to stop estrogen production and delay the onset of puberty until the normal age.

Researchers will give patients with LHRHa resistant precocious puberty Testolactone for six months. If the initial treatment is successful and patients do not experience very bad side effects, they will continue to receive the medication until puberty is desired. Throughout the therapy patients will receive frequent monitoring of their general state of health, hormone levels, and medication levels.

Conditions

  • Polyostotic Fibrous Dysplasia
  • Precocious Puberty

Interventions

DRUG

Testolactone

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    lead NIH

Study Design

Purpose
TREATMENT

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1982-10-31
Completion
2003-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00001181 on ClinicalTrials.gov