Evaluation of the SHT470 FA (30 mcg of ethinylestradiol and 3 mg of
drospirenone) on contraceptive efficacy, tolerance, cycle control and effects on
general well being and fluid-related symptoms in women seeking contraception and
with premenstrual disorders
A.F. Camargos (1), L.E. Borges (1), R.P. Andrade (2), J.M. Aldrighi
(3), C. Guazelli (4), C.F. Isaia (5), A. Petracco (6)
Reprodução Humana – Hospital das Clínicas da Universidade Federal de
Minas Gerais (1); Centro de Estudos em Reprodução Humana de Curitiba (2);
Santa Casa de Misericórdia de São Paulo (3); Escola Paulista de Medicina da
Universidade Federal de São Paulo (4); Centro de Medicina Reprodutiva Dr Carlos
Isaia Filho (5); Ponticia Universidade Católica do Rio Grande do Sul, Brazil
(6)
Introduction: Combined low-dose oral contraceptives provide a reliable
reversible contraception with a low incidence of adverse events. Despite this
advantages, compliance and pill discontinuation remain an issue. Cycle control
and the abscence of weigth gain are some determining factors with regard to oral
contraceptive continuation. Drospirenone is a new progestogen derived from 17
spirolactone, similar to natural progesterone, with antimineralocorticoid and
antiandrogenic properties.
Objectives: the aim of this study was to assess contraceptive efficacy,
tolerance, cycle control and effects on well being and fluid related symptoms of
a new contraceptive containing 30 mcg ethinylestradiol and 3 mg drospirenone, in
women seeking oral contraception with premenstrual disorder.
Materials and Methods: This study was a multicenter, open-label
6-cycle study from 6 centers in Brazil and it was approved by ethics committees.
The data analysed were obtained from 130 volunteers seeking oral contraception
and with premenstrual disorders who fulfilled all the inclusion criteria and
none of the exclusion criteria were observed. Informed consent was signed by all
subjects . Contraceptive efficacy and adverse events were assessed during 6
cycles of oral contraceptive use. Cycle control was obtained with a menstrual
calendar, recorded in all visits. The impact on well-being was assessed with the
Psychological General Well Being Index (PGWBI).
Results: The positive impact on well being was statisticaly
significant during the oral contraceptive use (p<0,000001). The PGWBI increased from the baseline visit (82,9) to cycle 6 visit (102,7). Adverse events reported were typical of those associated with oral contraceptive use, and was responsible for 11,3% of patients drop-out. The preparation was found to have a favorable effect on breast tenderness throughout the treatment. The incidence of intermenstrual bleeding was low and ocurred more often at the beginnig of the study. No pregnancy was reported.
Conclusions: The combination of 30 mcg ethinylestradiol and 3 mg
drospirenone provided effective oral contraception, cycle control, good
tolerability and a significant impact on well being, which improved compliance
in women with premenstrual disorder.
Acknowledgement: This study was sponsored by a grant of Schering do
Brasil, Química e Farmacêutica Ltda.
