The Effect of Hormonal Add-Back Therapy in Adolescents Treated With a GnRH Agonist for Endometriosis: A Randomized Trial
1 other identifier
interventional
53
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2007
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2007
CompletedFirst Posted
Study publicly available on registry
May 17, 2007
CompletedStudy Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedResults Posted
Study results publicly available
March 30, 2015
CompletedMarch 30, 2015
March 1, 2015
6.2 years
May 15, 2007
March 4, 2015
March 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bone Mineral Density
Adjusted mean change in total body areal bone mineral density (aBMD) over the 12 month trial
Baseline to 12 months
Secondary Outcomes (1)
Total Body Bone Mineral Content (BMC)
Baseline to 12 months
Study Arms (2)
Norethindrone acetate + estrogens
EXPERIMENTALSubjects randomized to the experimental arm received add-back therapy with norethindrone acetate 5 mg by mouth daily + conjugated equine estrogens 0.625 mg by mouth daily for the 12 months of study participation.
norethindrone acetate + placebo
PLACEBO COMPARATORSubjects randomized to the experimental arm received add-back therapy with norethindrone acetate 5 mg by mouth daily + a placebo capsule by mouth daily for the 12 months of study participation.
Interventions
Norethindrone acetate 5 mg by mouth daily + Conjugated equine estrogens 0.625 mg by mouth daily
norethindrone acetate 5 mg by mouth daily + Placebo capsule 1 pill by mouth daily
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Children's Hospitallead
- Brigham and Women's Hospitalcollaborator
Study Sites (1)
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
Related Publications (2)
Gallagher JS, DiVasta AD, Vitonis AF, Sarda V, Laufer MR, Missmer SA. The Impact of Endometriosis on Quality of Life in Adolescents. J Adolesc Health. 2018 Dec;63(6):766-772. doi: 10.1016/j.jadohealth.2018.06.027.
PMID: 30454733DERIVEDDiVasta AD, Feldman HA, Sadler Gallagher J, Stokes NA, Laufer MR, Hornstein MD, Gordon CM. Hormonal Add-Back Therapy for Females Treated With Gonadotropin-Releasing Hormone Agonist for Endometriosis: A Randomized Controlled Trial. Obstet Gynecol. 2015 Sep;126(3):617-627. doi: 10.1097/AOG.0000000000000964.
PMID: 26181088DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Sample of skeletally mature young women; Measurements of aBMD are two-dimensional and do not yield information regarding skeletal strength or microarchitecture
Results Point of Contact
- Title
- Dr. Amy D. DiVasta
- Organization
- Boston Children's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Amy D DiVasta, MD, MMSc
Boston Children's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 15, 2007
First Posted
May 17, 2007
Study Start
August 1, 2007
Primary Completion
October 1, 2013
Study Completion
January 1, 2015
Last Updated
March 30, 2015
Results First Posted
March 30, 2015
Record last verified: 2015-03