Bleeding pattern, tolerance and patient satisfaction with a drospirenone-containing oral contraceptive evaluated in 3488 women in Europe, the Middle East and Canada.
BACKGROUND
This study was conducted to assess the bleeding pattern, tolerance and patient satisfaction associated with an oral contraceptive (OC) containing 3 mg of drospirenone and 30 mcg of ethinyl estradiol under real-life conditions.


METHODS
A multicenter, prospective and observational six-cycle study was conducted in 12 countries in Europe, the Middle East and Canada. The efficacy variables included an assessment of bleeding patterns, premenstrual symptoms of water retention and patient satisfaction as determined by a visual analog scale.


RESULTS
A total of 3488 women was enrolled in the study. The percentage of women with intermenstrual bleeding decreased from 27.9% at baseline to 5.4% at the end of Cycle 6, while dysmenorrhea decreased from 67% to 17.7%. Also, amenorrhea decreased from 21.3% to 7.5%. The decreases in all three parameters were statistically significant (p<.0001). Approximately 70% of the women reported abdominal bloating and/or breast tenderness at baseline and less than 38% did so at the end of Cycle 6 (p<.0001). Patient satisfaction increased for all investigated items. Upon completion of the study, 86.2% of the women answered "yes" to continuing treatment with this OC.


CONCLUSIONS
The OC containing 3 mg of drospirenone and 30 mcg of ethinyl estradiol has beneficial effects on bleeding pattern, symptoms of water retention and patient satisfaction.
Endrikat
Jan S
JS
Bayer Inc., Medical and Scientific Affairs, ON, Canada. jan.endrikat.b@bayer.com
Milchev
Nikola P
NP
Kapamadzija
Aleksandra
A
Georgievska
Jadranka
J
Gerlinger
Christoph
C
Schmidt
Werner
W
Feroze
Sleem
S
D000293:Adolescent; D000328:Adult; D000736:Androstenes / Q000008:administration & dosage* / Q000592:standards; D002170:Canada / Q000453:epidemiology; D015331:Cohort Studies; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage* / Q000592:standards; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000592:standards; D005060:Europe / Q000453:epidemiology; D005260:Female; D006801:Humans; D008796:Metrorrhagia / Q000139:chemically induced* / Q000453:epidemiology; D008877:Middle East / Q000453:epidemiology; D017060:Patient Satisfaction; D011446:Prospective Studies; D055815:Young Adult
D000736:Androstenes; D003277:Contraceptives, Oral, Combined; C534342:drospirenone and ethinyl estradiol combination; D004997:Ethinyl Estradiol