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Effects of 2 Mg Chlormadinone Acetate/0.03 Mg Ethinylestradiol In Journal für Reproduktionsmedizin und Endokrinologie – Journal of Reproductive Medicine and Endocrinology – Andrologie • Embryologie & Biologie • Endokrinologie • Ethik & Recht • Genetik Gynäkologie • Kontrazeption • Psychosomatik • Reproduktionsmedizin • Urologie Effects of 2 mg Chlormadinone Acetate/0.03 mg Ethinylestradiol in Primary Dysmenorrhoea: The BEDY (Belara(R) Evaluation on Dysmenorrhea) Study - an Open Non-Comparative, Non-Interventional Observational Study with 4,842 Women Schramm GAK, Waldmann-Rex S J. Reproduktionsmed. Endokrinol 2010; 7 (Sonderheft 1), 112-118 www.kup.at/repromedizin Online-Datenbank mit Autoren- und Stichwortsuche Offizielles Organ: AGRBM, BRZ, DVR, DGA, DGGEF, DGRM, D·I·R, EFA, OEGRM, SRBM/DGE Indexed in EMBASE/Excerpta Medica/Scopus Krause & Pachernegg GmbH, Verlag für Medizin und Wirtschaft, A-3003 Gablitz Effects of CMA/EE in Primary Dysmenorrhoea Effects of 2 mg Chlormadinone Acetate/ 0.03 mg Ethinylestradiol in Primary Dysmenorrhoea: The BEDY (Belara® Evaluation on Dysmenorrhea) Study – an Open, Non-Comparative, Non-Interventional Observational Study with 4,842 Women G. A. K. Schramm, S. Waldmann-Rex Background: This prospective, non-interventional, observational study designed to reflect the daily medical practice which is very important for the product observation liability investigated the effects of 2.0 mg chlormadinone acetate/0.03 mg ethinylestradiol (CMA/EE) on dysmenorrhoea and related problems. Study design: A total of 4,842 patients were observed during a six-cycle period (26,945.5 treatment cycles) in 608 office-based gynaecological centres throughout Germany. Results: The administration of CMA/EE significantly reduced the number of patients who suffered from menstrual pain (–50.4 %). Analgesic use and absenteeism from school or work due to dysmenorrhoea was reduced by 74.6 % in OC starters and 91.9 % in OC switchers. CMA/EE was well tolerated and provided high contraceptive efficacy, with a non-adjusted Pearl index of 0.289 (95 % confidence interval 0.11–0.63). Significant reductions (p ≤ 0.001, baseline vs. final visit) were also seen in intermenstrual bleeding, bleeding intensity, premenstrual syndrome, mood swings, breast tenderness, headache, acne-prone skin and greasy hair. Conclusions: This evaluation supports previous findings that CMA/EE is an effective, well-tolerated contraceptive, reducing menstrual pain (dysmenorrhoea) significantly. In addition, CMA/EE offers substantial further non-contra- ceptive benefits. J Reproduktionsmed Endokrinol 2010; 7 (Special Issue 1): 112–18. Key words: dysmenorrhoea; analgesic use; cycle stability; acne; oral contraceptive; chlormadinone acetate Introduction In women with primary dysmenorrhoea, of women on the use of analgesics and NSAIDs have been found to be signifi- absence from school or work due to dys- Complaints of dysmenorrhoea are wide- cantly more effective for pain relief than menorrhoea. spread among adolescent and young placebo [10]. OCs may be an appropriate adult women, with population surveys treatment choice in patients who do not We used a non-interventional study suggesting that up to 90 % of reproduc- wish to conceive. Research suggests that design to reflect daily medical practice tive-aged women suffer from some men- combination OCs suppress ovulation especially from underaged young strual pain [1–5]. Prevalence rates vary and endometrial tissue growth, thereby women, whom you can prescribe oral considerably, however, which may be decreasing menstrual fluid volume and contraceptives concerning the German explained by underreporting of symp- prostaglandin secretion with a subse- law [19]. toms [6]. Although many women self- quent decrease in intrauterine pressure medicate and never seek medical atten- and uterine cramping [9, 11]. This gener- Materials and Methods tion, dysmenorrhoea can profoundly dis- ally alleviates primary dysmenorrhoea rupt a sufferer’s personal life [1, 7]. It is in most patients. Study Subjects and Design frequently associated with time lost from This prospective, observational, non- school, work or other activities, com- The more recent application of chlor- interventional study – BEDY (Belara® pounding the emotional distress brought madinone acetate (CMA) in combina- Evaluation on Dysmenorrhea) – was con- on by the pain [8]. In view of the adverse tion with low-dose ethinylestradiol (EE) ducted according to the German Drug impact on a woman’s day-to-day life, the as an OC has positive effects on pre-ex- Law and quality standards issued by the need to minimise this condition is sig- isting dysmenorrhoea and cycle stability German Health Authority and was of nificant and valuable. Treatment is di- [12–16]. Another major benefit is seen non-interventional design to reflect daily rected at providing relief from the in relation to dermatological problems medical practice which is very important cramping pelvic pain and associated such as acne and acne-prone skin [17, for the product observation liability. Pre- symptoms (e. g., headache, nausea, vom- 18]. The aim of this observational non- scription of 2 mg CMA/0.3 mg EE was iting, diarrhoea) that typically accom- interventional study, important for the at the discretionary clinical judgement of pany or immediately precede the onset product observation liability, was to the treating gynaecologist, with exclu- of menstrual flow. The most commonly shed further light on the significance of sion criteria limited to the licensed used therapeutic modalities for medical changes in dysmenorrhoea and other contraindications as stated in the pre- management are non-steroidal anti-in- symptoms during the administration of 2 scribing information for Belara. The flammatory drugs (NSAIDs) and com- mg CMA/0.03 mg EE in daily practice. single patient inclusion criterion was the bined oral contraceptives (OCs) [6, 9]. We also present data from a large group wish for contraception. Furthermore, Received and accepted: July 1, 2010. From the Medical Department, Grünenthal GmbH, D-52076 Aachen, Germany Correspondence to: Dr. Georg A. K. Schramm, Medical Department, Grünenthal GmbH, D-52076 Aachen, Germany; e-mail: [email protected] 112 J Reproduktionsmed Endokrinol 2010; 7 (Special Issue 1) For personal use only. Not to be reproduced without permission of Krause & Pachernegg GmbH. Effects of CMA/EE in Primary Dysmenorrhoea gynaecologists were asked to preferen- tially enroll women who complained of dysmenorrhoea. All participating inves- tigators observed and documented the intake of 2.0 mg CMA/0.03 mg EE dur- ing a 6-month period, which took place between August 2003 and November 2004. Two investigations were carried out and documented: one at baseline and the other at the end of the 6-month obser- vation period. Beyond the conventional cycle of CMA/EE-intake (21 days of pill intake, followed by a 7-day pill-free in- terval), an extended-cycle regimen was also documented (2–6 blister strips, fol- lowed by a 7-day pill-free interval). During this study, we collected data from Figure 1: Age distribution of women in the efficacy sample (n = 4514). 4,824 patients who were enrolled by 608 office-based gynaecologists throughout for Windows (release 11.0.1). We calcu- tion comprised 26,945.50 treatment Germany. lated descriptive p-values for changes cycles and 2,073 woman-years. during the observation period using Efficacy and Tolerability Evalu- the Wilcoxon signed-rank test and Age, Occupation and Risk Fac- ation McNemar’s test. These were applied to tors Demographic and morphometric data distribution variables such as cycle sta- The median age of the efficacy popula- were documented at baseline, along with bility, dysmenorrhoea and other cycle- tion was 20.9 years. More than two- age, weight, risk factors for the adminis- related parameters. Metric results were thirds of women (n = 3,082; 68.3 %) tration of hormonal preparations and the described by mean average value, stan- were aged ≤ 24 years and 8.5 % (n = 384 reasons for starting or switching to dard deviation (SD), median and first, were aged > 34 years (Fig. 1). The CMA/EE. Primary endpoints were the 25th, 75th and 99th percentiles. Differ- youngest patient was 13 years, while the incidence and intensity of dysmenor- ences in sample sizes represent missing oldest was 51 years. rhoea, use of analgesics and absence data. The following formula served for from school or work. All efficacy param- evaluating contraceptive efficacy: Pearl According to age distribution, 2,571 eters (cycle stability, bleeding intensity, index = (number of pregnancies × patients (57.0 %) were students or in premenstrual syndrome, mood swings, 1,300)/(number of cycle equivalents at professional training. The remaining breast tenderness, headache and skin and 28 days). women reported being employed (n = hair condition) were defined as custom- 1,394; 30.9 %) or housewives (n = 479; ary used in non-interventional studies File analysis was performed by the data- 10.6 %). For 70 women (1.6 %), another according the established doctrine [20]. management programme DMSys (release occupation was stated or details were It should be noted that subjective state- 5.0). Validation methods were used to missing. ments of the young women and/or sub- improve the quality of data (e. g., date jective statements of the doctor were specification, consistency checks, simul- Pre-existing risk factors for OC adminis- made and, because this is a non-inter- taneous plausibility testing and extreme- tration included smoking (1,478 pa- ventional
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