Effect of a combination of ethinylestradiol 30 μg and drospirenone 3 mg on tolerance, cycle control, general well-being and fluid-related symptoms in women with premenstrual disorders requesting contraception
Received 3 August 2005; received in revised form 30 October 2005; accepted 30 October 2005. published online 23 October 2006.
Abstract
Purpose
Positive effects on premenstrual symptoms have been observed with low-dose oral contraceptives. Drospirenone is a synthetic progestogen with antiandrogenic and antimineralocorticoid effects. This open-label, multicenter study evaluated the effects of a combination of ethinylestradiol 30 μg and drospirenone 3 mg on safety, cycle control, general well-being and fluid-related symptoms in women with premenstrual disorders requesting contraception.
Materials and methods
A total of 241 healthy volunteers with symptoms of premenstrual disorder was enrolled in the study. Of the final sample, 203 completed the six-cycle treatment and were included in the efficacy analysis whereas 236 were included in the tolerability analysis. The subjects recruited to the study were required to fill up the Psychological General Well-Being Index (PGWBI).
Results
There was no significant change in body weight or blood pressure throughout the treatment. Adverse events reported by patients during treatment consisted of those already known to be associated with oral contraceptive use. PGWBI scores were significantly higher after six cycles of treatment compared with baseline values (p<.0001). A total of 198 (84.2%) subjects reported a great improvement in premenstrual symptoms.
Conclusions
The results of this study confirm that oral use of a combination of ethinylestradiol 30 μg and drospirenone 3 mg provides good cycle control, is well tolerated and has a positive impact on symptoms of premenstrual disorder.
aLaboratório de Reprodução Humana do Hospital das Clínicas da Universidade Federal de Minas Gerais, Minas Gerais, Brazil
bCentro de Estudos e Pesquisas em Reprodução Humana e Fertilização Assistida de Curitiba, Curitiba, Brazil
cDepartamento de Ginecologia e Obstetrícia da Santa Casa de Misericórdia de São Paulo, São Paulo, Brazil
dDepartamento de Obstetrícia da Universidade Federal de São Paulo, Escola Paulista de Medicina, São Paulo, Brazil
eDepartamento de Ginecologia e Obstetrícia do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo, São Paulo, Brazil
fCentro de Medicina Reprodutiva Dr. Carlos Isaia Filho, Porto Alegre, Brazil
gDepartamento de Ginecologia e Obstetrícia da Pontifícia Universidade Católica do Rio Grande do Sul, Rio Grande do Sul, Brazil
Corresponding author. Rua dos Otoni 881 sala 403, cep-30150270, Belo Horizonte, Brazil.
ABSTRACT