Abstract | OBJECTIVE: METHODS: Adolescents and young women (n=51) received a random, double-blind assignment to add-back with norethindrone acetate (5 mg/day) plus conjugated equine estrogens (0.625 mg/day) or norethindrone acetate plus placebo for 12 months. Body composition, bone mineral content, and bone mineral density (BMD) were obtained by dual-energy X-ray absorptiometry every 6 months. Quality-of-life measures were collected every 3 months. Intention-to-treat comparison of outcomes was conducted by repeated-measures analysis of variance. RESULTS: Thirty-four adolescents and young women completed the trial; dropouts did not differ from those who completed the trial. Bone mineral density was normal at baseline. At 12 months, total body bone mineral content and BMD had increased in the norethindrone acetate plus conjugated equine estrogens group (bone mineral content +37 g, P<.001 and BMD +0.012 g/cm, P=.05), but not in those receiving norethindrone acetate plus placebo (bone mineral content P=.19 and BMD P=.95). Lean mass increased only in those receiving conjugated equine estrogens (+1.4 kg, P=.001). Improvements in physical functioning domains of quality-of-life assessments were greater with norethindrone acetate plus conjugated equine estrogens (P=.005). No differences were seen at the hip or lumbar spine by dual-energy X-ray absorptiometry. No significant adverse events occurred. CONCLUSION: CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; www.clinicaltrials.gov, NCT00474851. LEVEL OF EVIDENCE: I.
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Authors | Amy D DiVasta, Henry A Feldman, Jenny Sadler Gallagher, Natalie A Stokes, Marc R Laufer, Mark D Hornstein, Catherine M Gordon |
Journal | Obstetrics and gynecology
(Obstet Gynecol)
Vol. 126
Issue 3
Pg. 617-627
(Sep 2015)
ISSN: 1873-233X [Electronic] United States |
PMID | 26181088
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
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Chemical References |
- Estrogens, Conjugated (USP)
- Gonadotropin-Releasing Hormone
- Norethindrone Acetate
- Norethindrone
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Topics |
- Absorptiometry, Photon
(methods)
- Adolescent
- Bone Density
(drug effects, physiology)
- Bone Resorption
(chemically induced, prevention & control)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Drug Administration Schedule
- Drug Therapy, Combination
- Endometriosis
(diagnosis, drug therapy)
- Estrogens, Conjugated (USP)
(administration & dosage)
- Female
- Follow-Up Studies
- Gonadotropin-Releasing Hormone
(adverse effects, antagonists & inhibitors)
- Humans
- Norethindrone
(administration & dosage, analogs & derivatives)
- Norethindrone Acetate
- Prospective Studies
- Quality of Life
- Risk Assessment
- Treatment Outcome
- Young Adult
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