Cycle control, safety and efficacy of a 24-day regimen of gestodene 60 microg/ ethinylestradiol 15 microg and a 21-day regimen of desogestrel 150 microg/ethinylestradiol 20 microg.
OBJECTIVE
This multicenter, open-label study was conducted to compare the cycle control, efficacy and safety of a 24-day regimen of a new ultra-low-dose oral contraceptive containing gestodene (GTD) 60 microg/ethinylestradiol (EE) 15 microg and a 21-day regimen of desogestrel (DSG) 150 microg/EE 20 microg.


METHODS
Healthy women at least 18 years of age who had had regular menstrual cycles for the prior 3 months were randomly assigned to treatment for six cycles.


RESULTS
Data from 1074 women were included in the analyses. Overall, 65% of cycles were normal with GTD/EE and 78% with DSG/EE. The overall incidence of breakthrough bleeding and/or spotting was 29% with GTD/EE and 20% with DSG/EE, with absence of bleeding occurring in 6% of cycles in the GTD/EE group and 1% of cycles in the DSG/EE group. The GTD/EE group had a significantly shorter length of bleeding episodes (4 vs. 5 days, p < 0.001), a significantly lower intensity of bleeding (p < 0.01) and a significantly shorter time for onset of withdrawal bleeding than the DSG/EE group (p < 0.001). Safety profiles for the two treatment groups were similar. Significantly more subjects in the DSG/ EE group withdrew because of breast pain (p = 0.03) and nausea or vomiting (p = 0.05). One pregnancy occurred in each treatment group.


CONCLUSIONS
The 24-day regimen of GTD 60 microg/EE 15 microg provided good efficacy, acceptable cycle control and a favorable safety profile compared with DSG/EE. This ultra-low-dose formulation offers unique advantages in efficacy and safety for oral contraception.
D000328:Adult; D003277:Contraceptives, Oral, Combined / Q000009:adverse effects / Q000494:pharmacology*; D003280:Contraceptives, Oral, Synthetic / Q000009:adverse effects / Q000494:pharmacology; D017135:Desogestrel / Q000009:adverse effects / Q000494:pharmacology*; D004334:Drug Administration Schedule; D004967:Estrogens / Q000009:adverse effects / Q000494:pharmacology*; D004997:Ethinyl Estradiol / Q000009:adverse effects / Q000494:pharmacology*; D005260:Female; D006801:Humans; D008597:Menstrual Cycle / Q000187:drug effects; D009652:Norpregnenes / Q000009:adverse effects / Q000494:pharmacology*
D003277:Contraceptives, Oral, Combined; D003280:Contraceptives, Oral, Synthetic; D004967:Estrogens; D009652:Norpregnenes; C033273:Gestodene; D004997:Ethinyl Estradiol; D017135:Desogestrel