Efficacy and safety of a low-dose 24-day combined oral contraceptive containing 20 micrograms ethinylestradiol and 3 mg drospirenone.
The aim of this open-label, multicenter, noncomparative study was to determine the efficacy, safety and bleeding profile of a new low-dose, monophasic combined oral contraceptive containing 20 micrograms ethinylestradiol and 3 mg drospirenone administered daily for 24 days followed by a 4-day hormone-free interval. Contraceptive efficacy was analyzed for 1018 women completing 11,140 treatment cycles. Eleven pregnancies occurred, giving a Pearl Index (PI) of 1.29 (upper limit of the 95% confidence interval [CI], 2.30); of these pregnancies, five were considered due to method failure, giving an adjusted PI of 0.72 (upper limit of the 95% CI, 1.69). A total of 7 (0.7%) women discontinued study medication because of irregular bleeding, suggesting a favorable bleeding profile. Overall, the treatment was well tolerated with an excellent safety profile. The majority of women (86%) stated that they were satisfied or very satisfied with the treatment and over 70% of women would have continued with the study medication.
Women's Health Institute, University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, New Brunswick, NJ, USA.
Gloria
G
Bachmann
Patricia J
PJ
Sulak
Carole
C
Sampson-Landers
Norbert
N
Benda
Joachim
J
Marr
D000293:Adolescent; D000328:Adult; D000736:Androstenes / Q000008:administration & dosage* / Q000009:adverse effects / Q000592:standards; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage* / Q000009:adverse effects / Q000592:standards; D004967:Estrogens / Q000008:administration & dosage* / Q000009:adverse effects / Q000592:standards; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects / Q000592:standards; D005260:Female; D006261:Headache / Q000139:chemically induced; D006801:Humans; D010349:Patient Compliance; D017060:Patient Satisfaction; D011247:Pregnancy; D045167:Progesterone Congeners / Q000008:administration & dosage* / Q000009:adverse effects / Q000592:standards; D014592:Uterine Hemorrhage / Q000139:chemically induced
D000736:Androstenes; D003277:Contraceptives, Oral, Combined; D004967:Estrogens; D045167:Progesterone Congeners; D004997:Ethinyl Estradiol; C035144:drospirenone