Comparative analysis of the effects of nomegestrol acetate/17 β-estradiol and drospirenone/ethinylestradiol on premenstrual and menstrual symptoms and dysmenorrhea

被引:30
作者
Witjes, Han [1 ]
Creinin, Mitchell D. [2 ]
Sundstrom-Poromaa, Inger [3 ]
Nguyen, Allison Martin [4 ]
Korver, Tjeerd [1 ]
机构
[1] MSD BV, Oss, Netherlands
[2] Univ Calif Davis, Dept Obstet & Gynecol, Sacramento, CA 95817 USA
[3] Uppsala Univ, Dept Womens & Childrens Hlth, Uppsala, Sweden
[4] Merck & Co Inc, Kenilworth, NJ USA
关键词
NOMAC/E2; DRSP/EE; MDQ; combined oral contraceptive; nomegestrol acetate; 17; beta-estradiol; drospirenone; ethinylestradiol; ORAL-CONTRACEPTIVES; 24/4; REGIMEN; DISTRESS QUESTIONNAIRE; ETHINYL ESTRADIOL; CYCLE CONTROL; 17-BETA-ESTRADIOL; DROSPIRENONE; ETHINYLESTRADIOL; TOLERABILITY; EFFICACY;
D O I
10.3109/13625187.2015.1016154
中图分类号
R1 [预防医学、卫生学];
学科分类号
1004 ; 120402 ;
摘要
Objectives To compare premenstrual and menstrual symptoms in healthy women using nomegestrol acetate/17 beta-estradiol (NOMAC/E2) and drospirenone/ethinylestradiol (DRSP/EE) via the Moos Menstrual Distress Questionnaire Form C (MDQ-C). Methods Women completed the MDQ-C at baseline and after completion of cycles 1, 3, 6 and 13, for the premenstrual (four days before most recent flow) and menstrual (most recent flow) phases in two randomized controlled trials. Treatment effects of NOMAC/E2 and DRSP/EE on the t-scores of eight MDQ-C symptom domains from 3522 women were examined, and the effects of both treatments on the score for cramps from 1779 women with moderate to severe cramps at baseline. Longitudinal data analysis methods were applied in both analyses. Results NOMAC/E2 users experienced a significant improvement in Pain, Water Retention, Negative Affect, Impaired Concentration and Behaviour Change domain scores in the menstrual phase compared with DRSP/EE users (p < 0.001 for all comparisons). However, Arousal (emotional and mental) scores worsened with NOMAC/E2 but not with DRSP/EE. Women with moderate to severe cramps experienced an improvement in the cramps score with NOMAC/E2 and DRSP/EE. Conclusions NOMAC/E2 was effective in reducing most premenstrual and menstrual symptoms, and was associated with significantly greater improvements in many MDQ-C domain scores compared with DRSP/EE.
引用
收藏
页码:296 / 307
页数:12
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