A large observational clinical evaluation of a desogestrel-containing combiphasic oral contraceptive in Germany.
OBJECTIVE
The aim of this observational study was to assess the influence of a new combiphasic oral contraceptive on cycle control, tolerability and acne in a large cohort of women who wanted to switch from their previous oral contraceptive.


METHODS
A total of 2,280 women were enrolled in this clinical evaluation at 232 centers in Germany. All women switched from their previous pill to a combiphasic oral contraceptive containing ethinylestradiol and desogestrel (combiphasic EE/DSG; comprising 25 microg desogestrel and 40 microg ethinylestradiol for 7 days followed by 125 microg desogestrel and 30 microg ethinylestradiol for 15 days and then a 6-day pill-free interval) for three cycles.


RESULTS
Most women (53%) had previously used a monophasic oral contraceptive containing 20 or 30-35 microg ethinylestradiol. The most frequent reasons for switching were bleeding irregularities (41% of women), other menstrual disorders (27%) and migraine/headache (10%). After switching to combiphasic EE/DSG, cycle control improved significantly: the incidences of spotting and breakthrough bleeding decreased from 33% and 23% of women, respectively, before the start of the study, to 7% and 3% of women at the end of the study period. At the end of the study, acne was no longer present in 37% of the 592 women who had acne at the start of the study, and subjective complaints such as headaches were less frequent than before. Most women were satisfied or very satisfied with the combiphasic oral contraceptive and 89% wished to continue using it.


CONCLUSIONS
The results of this observational clinical evaluation indicate that in everyday use, for women who wish to switch from another oral contraceptive, combiphasic EE/DSG is an effective and well-tolerated oral contraceptive, which improves cycle control and has a beneficial effect on acne.
Vree
M L
ML
Medical Services, NV Organon, OSS, The Netherlands.
Schmidt
J
J
D000152:Acne Vulgaris / Q000139:chemically induced*; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D015331:Cohort Studies; D003268:Contraception Behavior; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D003280:Contraceptives, Oral, Synthetic / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D017135:Desogestrel / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D005858:Germany; D006801:Humans; D008597:Menstrual Cycle / Q000187:drug effects*; D008875:Middle Aged; D017060:Patient Satisfaction
D003277:Contraceptives, Oral, Combined; D003280:Contraceptives, Oral, Synthetic; C442659:ethinyl estradiol-desogestrel combination; D004997:Ethinyl Estradiol; D017135:Desogestrel