Extended cycles with the combined oral contraceptive chlormadinone acetate 2 mg/ethinylestradiol 0.03 mg: pooled analysis of data from three large-scale, non-interventional, observational studies.
OBJECTIVE
The prescribing of extended regimens of oral contraceptives (OCs) is increasing in routine gynaecological practice as a means of reducing the number of annual menstrual bleeds. Typically, this involves taking one pill per day for, say, 84 days continuously (4×21 days), followed by a 7-day pill-free interval. Low-dose OCs are suitable for extended use, and many gynaecologists in Germany prescribe the combination of chlormadinone acetate 2 mg/ethinylestradiol 0.03 mg (CMA 2 mg/EE 0.03 mg). The aim of the current study was to assess the risks and benefits of CMA 2 mg/EE 0.03 mg in extended regimens, using pooled data from observational studies.


METHODS
This pooled analysis of three large-scale, non-interventional, observational studies assessed the results in women receiving Belara® (CMA 2 mg/EE 0.03 mg) according to an extended regimen compared with conventional regimens documented in the summary of product characteristics.


RESULTS
A total of 625 women were identified as extended-regimen users (mean±SD age 24.9±9.0 years). Extended-cycle use was associated with decreases in skin problems, dysmenorrhoea symptoms (as shown by reductions in analgesic use; absence from school, university, or work; and restrictions in leisure and sporting activities), cycle-dependent symptoms (e.g. headache/migraine, breast tenderness), withdrawal bleeding, bleeding duration and reduced libido. Mean bodyweight remained almost constant over 6 months. Only nine adverse drug reactions, none severe, were reported in eight women (1.3%).


CONCLUSIONS
This pooled analysis confirms that extended regimens of CMA 2 mg/EE 0.03 mg reduce cycle-related complaints and are very well tolerated.
gggoe@arcor.de
Gunther
G
Göretzlehner
Susanne
S
Waldmann-Rex
Georg A K
GA
Schramm
D000284:Administration, Oral; D000328:Adult; D002715:Chlormadinone Acetate / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology; D003277:Contraceptives, Oral, Combined / Q000009:adverse effects / Q000494:pharmacology*; D004997:Ethinyl Estradiol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology; D005260:Female; D006801:Humans; D008597:Menstrual Cycle / Q000187:drug effects*
D003277:Contraceptives, Oral, Combined; C488302:ethinylestradiol-chlormadinone acetate; D002715:Chlormadinone Acetate; D004997:Ethinyl Estradiol
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