Acceptability, safety and premenstrual symptomatology in women using an oral contraceptive containing gestodene 60mcg/ethinylestradiol 15mcg

Acceptability, safety and premenstrual symptomatology in women using an

oral contraceptive containing gestodene 60mcg/ethinylestradiol 15mcg

I.C. Barbosa (1), D. Faggion Jr (2), C. Isaia Filho (3), E.C. Baracat

(4), R. Acquaroli (5)

Department of Obstetrics, Gynecology and Human Reproduction, Federal

University of Bahia, Salvador, Bahia, Brazil (1); DFJ Clinica Médica, São

Paulo, Brazil (2); Centro de Medicina Reprodutiva Dr. Carlos Isaia Filho, Porto

Alegre, Brazil (3); São Paulo Hospital, Federal University of São Paulo,

Brazil (4); Wyeth Pharmaceutical, São Paulo, Brazil (5)

Objective: To evaluate acceptability, safety and premenstrual

symptomatology in a group of healthy women using an ultra-low dose oral

contraceptive containing gestodene 60mcg/ethinylestradiol 15mcg (Minesse).

Design and Methods: This was an open, non-comparative, multicenter

study carried out in Brazil, involving 163 women aged 18–39 years (mean 25+5

years). Patients were treated for six months with an oral regimen of gestodene

60mcg/ethinylestradiol 15mcg daily from day 1–24 of the menstrual cycle,

followed by a 4-day pill-free interval from day 25–28 of the cycle.

Evaluations carried out at baseline and after three and six months of pill use

included acceptability as measured by the analysis of reasons for premature

discontinuation, physical/gynecological examinations, blood pressure, weight,

hemoglobin, hematocrit, SGOT, SGPT and urinalysis. To evaluate premenstrual

symptomatology, the Moos Menstrual Distress Questionnaire (MDQ) was completed at

baseline, and at the end of cycles 3 and 6 for 3 consecutive days (days 25, 26

and 27 of the cycle). A descriptive analysis of acceptability variables was

carried out and Student’s t-test for paired values was used to evaluate

variations in safety parameters. Wilcoxon’s test was used to compare the MDQ

scores obtained throughout the study.

Results: Seventeen patients discontinued the study prematurely, ten

because of adverse events, one due to a serious adverse event (pregnancy). No

adverse metabolic effects were observed. The adverse event most frequently

reported was breakthrough bleeding (32.7%). Menstruation tended to become more

regular with increased time of pill use. Systolic and diastolic blood pressure

was significantly lower at month 6 when compared to baseline (p<0.02). Body weight and laboratory tests were unchanged. After six cycles, statistically significant changes were found in the total MDQ score (p<0.0001) and in the sum of scores for all the factors evaluated except for behavioral change and autonomic reactions (pain, p<0.0001; concentration, p=0.01; water retention, p<0.0001; negative affect, p<0.0001; arousal, p<0.001; control, p=0.04).

Conclusions: The treatment was safe, well accepted and tolerated.

Failure rate correlated well with that of other oral contraceptives. In addition,

patients showed a statistically significant improvement in well being, as

demonstrated by a change in several of the premenstrual complaints and symptoms

measured by the Moos Menstrual Distress Questionnaire.

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