Switching hormonal contraceptives to a chlormadinone acetate-containing oral contraceptive. The Contraceptive Switch Study.
OBJECTIVE
This prospective observational noninterventional study aimed at collecting information on changes in cycle control, dysmenorrhea, androgen-related skin conditions and tolerability in a large cohort of women who switched their oral contraceptive (OC) to 2.0 mg chlormadinone acetate (CMA)/0.03 mg ethinylestradiol (EE) (Belara).


METHODS
In a total of 20,897 women who were enrolled in a four-cycle clinical evaluation at 1597 gynecological practices throughout Germany, there are 16,781 women who switched from another contraceptive.


RESULTS
The most frequently mentioned complaint for switching contraceptive was seborrhea/acne (6933/16,781 women; 41.3%). This was followed by cycle irregularities (18.8%), headache (15.9%), breast tension (15.1%), amenorrhea (14.9%), spotting (12.8%) and dysmenorrhea (11.7%). After switching to CMA/EE treatment, these symptoms decreased substantially or even disappeared in a large number of women. The vast majority of study participants scored both tolerability and well-being on CMA/EE intake as 'very good' or 'good'. The results revealed that 13,508 women (80.5%) stated being more satisfied or even much more satisfied on CMA/EE intake compared to their previously used contraceptive; most of them had taken progestins of the nortestosterone type. CMA/EE produced beneficial effects on skin conditions and well-being in OC switchers who experienced dissatisfaction with their previous contraceptive regimen.


CONCLUSIONS
The results of this observational study support that 2.0 mg CMA/0.03 mg EE is well tolerated, provides a reliable cycle stability and is very effective in diminishing dysmenorrhea and other cycle-related complaints. Women suffering from problems on hormonal contraception received benefit from switching to the progesterone derivative CMA-containing OC.
Schramm
Georg
G
Grünenthal GmbH, Medical Department, 52099 Aachen, Germany. georg.schramm@grunenthal.de
Heckes
Birgit
B
D000293:Adolescent; D000328:Adult; D002715:Chlormadinone Acetate / Q000009:adverse effects*; D003268:Contraception Behavior; D003277:Contraceptives, Oral, Combined / Q000009:adverse effects*; D004412:Dysmenorrhea / Q000188:drug therapy; D004997:Ethinyl Estradiol / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008597:Menstrual Cycle / Q000187:drug effects*; D019370:Observation; D010349:Patient Compliance; D017060:Patient Satisfaction; D011446:Prospective Studies; D012625:Sebaceous Gland Diseases / Q000188:drug therapy; D012627:Sebaceous Glands / Q000187:drug effects*
D003277:Contraceptives, Oral, Combined; D002715:Chlormadinone Acetate; D004997:Ethinyl Estradiol