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J Pediatr Adolesc Gynecol. 2016 Dec;29(6):635-642. doi: 10.1016/j.jpag.2016.05.012. Epub 2016 Jun 7.

Effect of Extended 30 μg Ethinyl Estradiol with Continuous Low-Dose Ethinyl Estradiol and Cyclic 20 μg Ethinyl Estradiol Oral Contraception on Adolescent Bone Density: A Randomized Trial.

Author information

1
New Age Medical Research Corporation, Miami, Florida. Electronic address: jkgersten@gmail.com.
2
Teva Branded Pharmaceutical Products R&D, Inc, West Chester, Pennsylvania.
3
Teva Global Medical Affairs, Petach Tikva, Israel.
4
Teva Branded Pharmaceutical Products R&D, Inc, Frazer, Pennsylvania.

Abstract

STUDY OBJECTIVE:

To compare changes in lumbar spine bone mineral density after 12 months of a 91-day extended regimen or 28-day combined oral contraceptive with those in a healthy reference group not using hormonal contraceptives.

DESIGN:

Phase 2, multicenter, open-label, randomized, controlled study.

SETTING:

Forty-five academic centers, clinical research centers, and community practices in the United States.

PARTICIPANTS:

Eight hundred twenty-nine postmenarcheal adolescent girls aged 12-18 years.

INTERVENTIONS:

Adolescents were randomly assigned to 91-day levonorgestrel (LNG)/ethinyl estradiol (EE) extended regimen (84 days of LNG 150 μg/EE 30 μg with 7 days of EE 10 μg [LNG/EE extended regimen]) or 28 days of LNG/EE (21 days of LNG 100 μg/EE 20 μg with 7 days of placebo [LNG/EE 21/7]) for 12 months. A reference group not seeking hormonal contraception was also evaluated.

MAIN OUTCOME MEASURES:

The primary end point was mean percent change in lumbar spine bone mineral density measured using dual-energy x-ray absorptiometry.

RESULTS:

Of 1361 adolescents randomized/enrolled, 829 were included in the primary analysis. Mean changes in lumbar spine bone mineral density were +2.26% with LNG/EE extended regimen, +1.45% with LNG/EE 21/7, and +2.50% in the reference group. Noninferiority of the LNG/EE extended regimen compared with the reference group was shown. A statistically significant treatment difference was found between LNG/EE 21/7 and the reference group (1.05%; 95% confidence interval, 0.61%-1.49%) but not between LNG/EE extended regimen and the reference group (0.23%; 95% confidence interval, -0.20% to 0.67%). No new safety signals were noted.

CONCLUSION:

Compared with the reference group, bone accrual was statistically significantly lower among LNG/EE 21/7 users but not among LNG/EE 30-μg extended regimen users. Additional research is needed to clarify the clinical relevance of these findings.

KEYWORDS:

Adolescent; Bone density; Bone development; Combined hormonal contraceptive; Ethinyl estradiol; Levonorgestrel; Oral contraceptive

PMID:
27287084
DOI:
10.1016/j.jpag.2016.05.012
[Indexed for MEDLINE]

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