Phase 2
N=53
The Effect of Hormonal Add-Back Therapy in Adolescents Treated With a GnRH Agonist for Endometriosis: A Randomized Trial
Endometriosis
Bottom Line
View on ClinicalTrials.gov: NCT00474851 ↗Enrolled (actual)
53
Serious AEs
25.5%
Results posted
Mar 2015
Primary outcome: Primary: Bone Mineral Density — 0.01; -0.11 g/cm^2 — p=0.10
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Norethindrone acetate + estrogens (Drug); norethindrone acetate + placebo (Drug)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- Female
- Sponsor
- Boston Children's Hospital
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bone Mineral Density |
0.01; -0.11 | 0.10 |
| SECONDARY Total Body Bone Mineral Content (BMC) |
37; 15 | 0.02 sig |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00474851). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.