Contraceptive efficacy and safety of low dose oral monophasic
D Tutunaru1, I Badea2, F D Lebit1, M C Dumitrascu2
Emergency Hospital, Bucharest, Romania and 2Universitary Emergency Hospital,
Objective To determine contraceptive efficacy and safety of
the long term administration of the low dose oral monophasic contraceptive
containing 0,02 mg ethinylestradiol/2mg chlormandione acetate.
Design and methods Two years prospective, nonrandomized, open label study. Inclusion
criteria: female subjects in reproductive age, sexually active, with regular
menses, who have signed inform consent. Exclusion criteria: smokers over 35
years, BMI over 30, irregular menses, PCOS, abnormal cervical cytology, aberrant
coagulation patterns, abnormal liver tests, failure to comply with pills
administration schedule. Patients had to fill a diary recording symptoms as:
headache, breast tension, nervousness, libido status, nausea, vomiting and
bleeding pattern. Any adverse event was noted down and analyzed concerning
relation to drug administration.
Results From 80 patients who matched the
inclusion criteria, 67 finished the study. There was no pregnancy during the
study, except one case who failed to take investigational product according to
schedule. There was no major abnormal bleeding pattern, spotting being the major
symptom in 21 cases, and 7 cases of irregular bleeding in the first 3 months
which vanished afterwards.
Conclusions The low dose oral monophasic
contraceptive containing 0,02 mg ethinylestradiol/2mg chlormandione acetate
proved to be very efficient in preventing pregnancy and with no serious adverse