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

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Children's Hospital; Boston Children’s Hospital
• Collaborator: Brigham and Women's Hospital
• Treatments: Deslorelin; Estrogens; Estrogens, Conjugated (USP); Norethindrone; Norethindrone Acetate

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 intra-muscular 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