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

Abstract

Objectives To compare premenstrual and menstrual symptoms in healthy women using nomegestrol acetate/17β-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.

(ClinicalTrials.gov: NCT00413062 and NCT00511199).

Chinese Abstract

摘要

目的 通过应用经期不适问卷C表格，调查使用醋酸诺美孕酮/17β雌二醇（NOMAC/E2）和屈螺酮/炔雌醇(DRSP/EE) 避孕的健康妇女， 了解其经前期和经期的不适及改善情况。

方法 在两个随机对照的临床试验中，受试妇女分别于基线，服药的第1、3、6、13个周期，从月经前期（指月经出血前4天）到月经期（月经出血第一天开始）完成经期不适问卷的C表格。3522名妇女在使用NOMAC/E2和DRSP/EE后，完成经期不适问卷所涉及的八大项相关症状调查。同时对1779名在基线时有中到重度痛经的妇女，对其服药后痛经的改善情况进行评估。在每一项分析中，均采用纵向数据分析法。

结果 NOMAC/E2使用者在月经期疼痛、水潴留、消极情绪、注意力不集中、行为改变等方面的评分，与DRSP/EE使用者相比较，均有显著的改善（p＜0.001）。然而，NOMAC/E2使用者身心健康感（不论是情绪还是精神）的评分是下降的。对于有着中到重度痛经的妇女，使用NOMAC/E2和DRSP/EE后，其疼痛都是改善的。

结论 NOMAC/E2对于改善经前期和经期的不适症状都是有效的，与DRSP/EE相比，对经期不适问卷C表格涉及的许多主要症状，均有较大的显著的改善作用。

Keywords:

• NOMAC/E2
• DRSP/EE
• MDQ
• combined oral contraceptive
• nomegestrol acetate
• 17β-estradiol
• drospirenone
• ethinylestradiol

ACKNOWLEDGEMENTS

Financial support for this study was provided by Merck & Co., Inc., Kenilworth, NJ.

Editorial support was provided by PAREXEL and funded by Merck & Co., Inc., Kenilworth, NJ. The authors also thank Kristen Lewis of Merck & Co., Inc., Kenilworth, NJ, for editorial assistance.

Declaration of interest: Mitchell D. Creinin has received research grants from Merck & Co., Inc. and Medicines360, and has acted as a consultant for Merck & Co., Inc., Teva and Danco Laboratories. Inger Sundström-Poromaa has received compensation as a lecturer for Bayer Schering Pharma, Merck & Co., Inc., and Lundbeck A/S; and has served on a medical advisory board for Novo Nordisk AB. Han Witjes is a former employee of MSD BV, Oss, The Netherlands. Tjeerd Korver is a former employee of MSD BV, Oss, The Netherlands and currently providing consultancy services to Merck & Co., Inc. Allison Martin Nguyen is an employee of Merck & Co., Inc., Kenilworth, NJ, USA and may own stock/stock options in the company.

Author Contributions

Conceived, designed or planned the study: TK; Collected or assembled the data: TK; Performed or supervised analyses: TK and HW; Provision of study materials of patients: IS-P; Interpreted the results; wrote sections of the initial draft or provided suggestions for revision; and reviewed and approved final version: all authors.