The Effect of Hormonal Add-Back Therapy in Adolescents Treated With a GnRH Agonist for Endometriosis: A Randomized Trial
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometriosis |
Drug: Conjugated equine estrogens Drug: Placebo Drug: Norethindrone acetate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effect of Hormonal Add-Back Therapy in Adolescents Treated With a GnRH Agonist for Endometriosis: A Randomized Trial |
- Bone mineral density [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Volumetric bone mineral density [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: I |
Drug: Conjugated equine estrogens
Conjugated estrogens 0.625 mg PO daily
Other Name: Premarin
Drug: Norethindrone acetate
Norethindrone acetate 5 mg PO daily
Other Name: Aygestin
|
|
Placebo Comparator: N
Placebo group
|
Drug: Placebo
Placebo capsule 1 pill PO daily
Drug: Norethindrone acetate
Norethindrone acetate 5 mg PO daily
Other Name: Aygestin
|
Detailed Description:
Endometriosis has become increasingly recognized as a chronic illness which begins during adolescence. Untreated endometriosis may lead to chronic pain and infertility. As recognition of the need for prompt therapy increases, so does the length of time patients will be exposed to treatments. As a result, there exists a pressing need to evaluate adjunctive measures that may limit the associated negative health consequences of treatment.
A gonadotropin-releasing hormone (GnRH) agonist is one medication utilized for patients who have failed other treatments. While GnRH-agonists are effective in relieving symptoms, their long-term use is problematic. GnRH agonists induce a low-estrogen state, causing deleterious effects on bone mineralization. These negative consequences are especially important for our pediatric patients. Adolescence is the critical period in a woman's life for bone acquisition and attainment of peak bone mass. Anything that interferes with this process puts patients at risk for lifelong low bone density and future fracture.
"Add-back" therapy appears to be a promising adjunct to treatment for prevention of this bone loss. Daily therapy with low-doses of hormones preserves bone density in adult patients, without altering the efficacy of the GnRH-agonist. However, no data exist on the effect of add-back therapy in adolescents.
The aim of the current study is to evaluate the safety and efficacy of two add-back regimens, norethindrone acetate + placebo or norethindrone acetate + conjugated estrogens, for the preservation of skeletal health and quality of life in adolescents with endometriosis treated with a GnRH-agonist.
Eligibility| Ages Eligible for Study: | 13 Years to 22 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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 IM 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
Contacts and Locations| Contact: Amy D DiVasta, MD, MMSc | 617-355-3792 | amy.divasta@childrens.harvard.edu |
| Contact: Catherine M Gordon, MD, MSc | 617-355-5484 | catherine.gordon@childrens.harvard.edu |
| United States, Massachusetts | |
| Children's Hospital Boston | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Amy DiVasta, MD 617-355-7181 amy.divasta@childrens.harvard.edu | |
| Principal Investigator: | Amy D DiVasta, MD, MMSc | Children's Hospital Boston |
More Information
No publications provided
| Responsible Party: | Amy DiVasta, Children's Hospital Boston |
| ClinicalTrials.gov Identifier: | NCT00474851 History of Changes |
| Other Study ID Numbers: | 07-01-0004 |
| Study First Received: | May 15, 2007 |
| Last Updated: | June 21, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Children's Hospital Boston:
|
Endometriosis Adolescents Bone density GnRH Agonist Add-back therapy |
Additional relevant MeSH terms:
|
Endometriosis Genital Diseases, Female Estrogens Estrogens, Conjugated (USP) Norethindrone Norethindrone acetate Deslorelin Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
Pharmacologic Actions Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Therapeutic Uses Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013