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.
[No authors listed]
OBJECTIVE: Thismulticenter, 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 monthswere 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. TheGTD/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
Batch Citation Matcher
|[pic]1: Eur J Contracept Reprod Health Care. 1999 Nov;4 |
|Suppl 2:9-15. |
The safety and contraceptive efficacy of a 24-day low-doseoral contraceptive regimen containing gestodene 60 microg and ethinylestradiol 15 microg.
[No authors listed]
OBJECTIVE: The safety and contraceptive efficacy of a new 24-day regimen of an oral contraceptive combination containing gestodene (GTD) 60 microg and ethinylestradiol (EE) 15 microg was evaluated in an open-label, multicenter study. METHODS: Adult women received GTD 60microg/EE 15 microg from day 1 to 24 and 4 days of placebo during a 28-day cycle for either 13 or 19 cycles. RESULTS: Of the 1515 subjects enrolled, 1496 were included in the intent-to-treat analysis. A total of three pregnancies were reported during the 18 194 treatment cycles of the study, yielding a Pearl index of 0.21. Life-table analysis, based on 16 954 cycles, gave an accidental pregnancyrate of 0.0033. The most frequent adverse events were headache (reported in 35% of subjects), absence of bleeding (16%), flu-like syndrome (15%), pharyngitis (15%) and abdominal pain (15%). The most frequent reasons for withdrawal from the study were metrorrhagia, flu syndrome and absence of bleeding. Analyses of withdrawal and intermenstrual bleeding and spotting indicated acceptable cycle control.CONCLUSIONS: The 24-day GTD 60 microg/EE 15 microg regimen appears to be a well-tolerated and effective method for low-dose oral contraception. The current formulation offers an ultra-low steroidal dosage combined with a reduced pill-free interval to improve contraceptive efficacy
|Contraception. 1999 Sep;60(3):151-4. |
Endometrial histology during use of a low-dose...