
Effects on bone mineral density of a monophasic combined oral contraceptive containing nomegestrol acetate/17β‐estradiol in comparison to levonorgestrel/ethinylestradiol
Author(s) -
SØRDAL TERJE,
GROB PAUL,
VERHOEVEN CAROLE
Publication year - 2012
Publication title -
acta obstetricia et gynecologica scandinavica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.401
H-Index - 102
eISSN - 1600-0412
pISSN - 0001-6349
DOI - 10.1111/j.1600-0412.2012.01498.x
Subject(s) - medicine , ethinylestradiol , bone mineral , levonorgestrel , femoral neck , regimen , gestodene , bone density , urology , trochanter , gynecology , osteoporosis , population , family planning , environmental health , research methodology
Objective. To compare the effects of a monophasic combined oral contraceptive containing nomegestrol acetate/17β‐estradiol (NOMAC/E2) on bone mineral density with a combined oral contraceptive containing levonorgestrel/ethinylestradiol (LNG/EE). Design. Prospective, randomized, open‐label, comparative clinical study. Setting. Gynecology center in Norway. Population. One hundred and ten women (20–35 years old) actively seeking contraception. Methods. For 26 consecutive 28‐day cycles, women received one of the following two treatments: NOMAC/E2 (2.5 mg/1.5 mg) in a 24/4‐day regimen ( n = 56); or LNG/EE (150 μg/30 μg) in a 21/7‐day regimen ( n = 54). Main outcome measures. Bone mineral density of the lumbar spine, femoral neck, hip and trochanter (measured by dual energy X‐ray absorptiometry); associated z‐scores of the lumbar spine and femoral neck. Results. In NOMAC/E2 users, mean (±SD) z‐score change from baseline for lumbar spine and femoral neck were 0.019 ± 0.242 and −0.007 ± 0.228, respectively, vs. 0.121 ± 0.269 and 0.044 ± 0.253 in LNG/EE users, respectively. Differences between treatment groups were not significant ( p = 0.19 and p = 0.57, respectively). There were no significant differences between changes in hip and trochanter z‐scores between NOMAC/E2 and LNG/EE treatments. Conclusions. After two years, NOMAC/E2 had no clinically relevant effect on bone mineral density. No significant difference in the effect on bone mineral density between NOMAC/E2 and LNG/EE was observed.