The Effect of Hormonal Add-Back Therapy in Adolescents Treated With a GnRH Agonist for Endometriosis: A Randomized Trial

Completed · Phase 2 · Has a placebo group

Conditions studied: Endometriosis

In brief

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.

Key facts

Study ID

NCT00474851

Run by

Boston Children's Hospital

People needed

53

Starts

2007-08-01

Expected to finish

2015-01-01

Last updated by the study team

2015-03-30

Who can join

Age: 13 and older, up to 22. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 intra-muscular every 3 months

You may not qualify if…

• 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

Where it is running

• Children's Hospital Boston — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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