Overview

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