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The Effect of Hormonal Add-Back Therapy in Adolescents Treated With a GnRH Agonist for Endometriosis: A Randomized Trial
This study is not yet open for participant recruitment.
Verified by Children's Hospital Boston, May 2007
Sponsors and Collaborators: Children's Hospital Boston
Brigham and Women's Hospital
Information provided by: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00474851
  Purpose

The purpose of this study is to determine whether a regimen of norethindrone acetate + placebo or norethindrone acetate + conjugated estrogens is superior in maintaining skeletal health and quality of life in adolescents treated with a GnRH agonist for endometriosis.


Condition Intervention Phase
Endometriosis
Drug: Norethindrone acetate
Drug: conjugated estrogens
Phase II

MedlinePlus related topics: Endometriosis Minerals
Drug Information available for: Gonadorelin Gonadorelin hydrochloride LH-RH Estrogens, conjugated Norethindrone acetate Norethindrone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: The Effect of Hormonal Add-Back Therapy in Adolescents Treated With a GnRH Agonist for Endometriosis: A Randomized Trial

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Bone mineral density [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Volumetric bone mineral density [ Time Frame: 12 months ]
  • Quality of life [ Time Frame: 12 months ]

Estimated Enrollment: 50
Detailed Description:

Endometriosis has become increasingly recognized as a chronic illness which begins during adolescence. Untreated endometriosis may lead to chronic pain and infertility. As recognition of the need for prompt therapy increases, so does the length of time patients will be exposed to treatments. As a result, there exists a pressing need to evaluate adjunctive measures that may limit the associated negative health consequences of treatment.

A gonadotropin-releasing hormone (GnRH) agonist is one medication utilized for patients who have failed other treatments. While GnRH-agonists are effective in relieving symptoms, their long-term use is problematic. GnRH agonists induce a low-estrogen state, causing deleterious effects on bone mineralization. These negative consequences are especially important for our pediatric patients. Adolescence is the critical period in a woman’s life for bone acquisition and attainment of peak bone mass. Anything that interferes with this process puts patients at risk for lifelong low bone density and future fracture.

“Add-back” therapy appears to be a promising adjunct to treatment for prevention of this bone loss. Daily therapy with low-doses of hormones preserves bone density in adult patients, without altering the efficacy of the GnRH-agonist. However, no data exist on the effect of add-back therapy in adolescents.

The aim of the current study is to evaluate the safety and efficacy of two add-back regimens, norethindrone acetate + placebo or norethindrone acetate + conjugated estrogens, for the preservation of skeletal health and quality of life in adolescents with endometriosis treated with a GnRH-agonist.

  Eligibility

Ages Eligible for Study:   13 Years to 22 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 13-22 years, at least two years post-menarche
  • Body mass index (BMI, kg/m2) between 18 -30 kg/m2
  • Surgical diagnosis of endometriosis
  • Clinical decision to treat with a GnRH agonist, leuprolide depot (Lupron Depot®; TAP Pharmaceuticals, Inc.) 11.25 mg IM every 3 months

Exclusion Criteria:

  • Concomitant chronic diseases which affect bone health, such as cystic fibrosis, inflammatory bowel disease, renal disease, or diabetes mellitus
  • Markedly impaired liver function or liver failure
  • Personal history of thromboembolic event (such as deep venous thrombosis)
  • Medication use known to affect bone metabolism:

    • Glucocorticoid therapy (including inhaled steroids) or anticonvulsants used in the last 6 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00474851

Contacts
Contact: Amy D DiVasta, MD, MMSc 617-355-3792 amy.divasta@childrens.harvard.edu
Contact: Catherine M Gordon, MD, MSc 617-355-5484 catherine.gordon@childrens.harvard.edu

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
Brigham and Women's Hospital
Investigators
Principal Investigator: Amy D DiVasta, MD, MMSc Children's Hospital Boston
  More Information

Study ID Numbers: 07-01-0004
Study First Received: May 15, 2007
Last Updated: May 15, 2007
ClinicalTrials.gov Identifier: NCT00474851  
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital Boston:
Endometriosis
Adolescents
Bone density
GnRH Agonist
Add-back therapy

Study placed in the following topic categories:
Genital Diseases, Female
Deslorelin
Estrogens, Conjugated (USP)
Norethindrone
Endometriosis
Norethindrone acetate

Additional relevant MeSH terms:
Estrogens
Molecular Mechanisms of Pharmacological Action
Contraceptive Agents
Physiological Effects of Drugs
Contraceptives, Oral
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Enzyme Inhibitors
Reproductive Control Agents
Hormones
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on January 16, 2009