Testolactone for the Treatment of Girls With LHRH Resistant Precocious Puberty

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001181
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: May 2003
  Purpose

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.


Condition Intervention Phase
Polyostotic Fibrous Dysplasia
Precocious Puberty
Drug: Testolactone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
Official Title: Testolactone Treatment of Girls With LHRH Analog-Resistant Precocious Puberty Due to Autonomous, Non-Neoplastic Ovarian Estrogen Secretion

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 100
Study Start Date: October 1982
Estimated Study Completion Date: May 2003
Detailed Description:

Females with precocious puberty who have low levels of serum gonadotropins and high levels of serum estrogen, or those who have demonstrated an inadequate clinical response to therapy with the luteinizing hormone releasing hormone analog (Lupron, Histerelin, Deslorelin), will be treated with testolactone. Testolactone inhibits aromatase, the last enzyme of estrogen biosynthesis. The goal of treatment is to inhibit estrogen secretion and thus delay secondary sexual maturation and epiphyseal closure until the normal age. The intent is to alleviate the psychological problems and short stature frequently associated with this disorder. Throughout therapy, patients will receive frequent clinical, hormonal, and toxicological monitoring. The initial treatment period will be six months. If patients respond to the treatment and tolerate it well, testolactone will be given until puberty is desired. Patients who exhibit pubertal levels of serum gonadotropins during testolactone therapy, indicating the onset of secondary, gonadotropin-dependent puberty, will receive an LHRH analog in addition to testolactone.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

Patients are girls aged 1-8 years (on entry to the study) with gonadotropin-independent precocious puberty. All ethnic groups are included.

EXCLUSION CRITERIA:

Males are excluded, as are patients with clinically-significant hepatic and/or renal impairment (testolactone is metabolized via the liver and kidneys).

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00001181

Locations
United States, Maryland
National Institute of Child Health and Human Development (NICHD)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001181     History of Changes
Other Study ID Numbers: 820165, 82-CH-0165
Study First Received: November 3, 1999
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
McCune-Albright Syndrome
Aromatase Inhibitor
Teslac

Additional relevant MeSH terms:
Fibrous Dysplasia, Polyostotic
Puberty, Precocious
Fibrous Dysplasia of Bone
Osteochondrodysplasias
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Gonadal Disorders
Endocrine System Diseases
Testolactone
Aromatase Inhibitors
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014