Eloine should be taken once daily for 28 days, starting on the first day of menstruation. Each subsequent pack should be started the day after the last tablet of the previous pack without a break. The last four tablets in the pack contain inactive placebo, providing a hormone-free interval of 4 days (in contrast to the 7-day interval for Yasmin).
Drospirenone is a spironolactone analogue that has antimineralocorticoid and antiandrogenic properties, and may have beneficial effects on acne and fluid retention. The shortened 4-day hormone-free interval has the potential to reduce the incidence of hormone withdrawal symptoms, such as pelvic pain, headaches, bloating and breast tenderness. Studies have also shown that the combination can alleviate premenstrual symptoms.
Contraceptive efficacyfour studies (n=2386) showed a total of 16 pregnancies during a treatment exposure time of 729,537 days (26,055 cycles), resulting in a Pearl Index (number of pregnancies per 100 woman-years) of 0.80 (upper two-sided 95% CI limit of 1.30). Of these pregnancies, 7 were attributed to method failures, resulting in an adjusted Pearl Index of 0.41 (upper two-sided 95% CI limit of 0.85).
The estimated one-year cumulative contraceptive protection rate was 99.21%.
The cycle control and bleeding profile of ethinylestradiol 20 microgram and drospirenone 3mg in a 24/4 regimen are comparable to those of an established low-dose combined oral contraceptive (ethinylestradiol 20 microgram and desogestrel 150 microgram in a 21/7 regimen).
The safety and efficacy of low-dose ethinylestradiol with drospirenone in women with moderate acne vulgaris were assessed in two randomised, double-blind studies.
At 6 months, ethinylestradiol with drospirenone was associated with a significantly greater reduction than placebo in inflammatory lesions (49.3% vs 33.7%) and total lesion counts (44.6% vs 28.1%).
More patients experienced 'clear' or 'almost clear' skin (as indicated by rating on the Investigator's Static Global Assessment scale) with the combination than with placebo (18.6% vs 6.8%).
The combination of ethinylestradiol and drospirenone was well-tolerated, with a safety profile typical of that associated with low-dose combined hormonal contraceptives.