Effect of a combination of ethinylestradiol 30 microg and drospirenone 3 mg on tolerance, cycle control, general well-being and fluid-related symptoms in women with premenstrual disorders requesting contraception.
OBJECTIVE
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 microg and drospirenone 3 mg on safety, cycle control, general well-being and fluid-related symptoms in women with premenstrual disorders requesting contraception.


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 microg and drospirenone 3 mg provides good cycle control, is well tolerated and has a positive impact on symptoms of premenstrual disorder.
Borges
Lavínia E
LE
Laboratório de Reprodução Humana do Hospital das Clínicas da Universidade Federal de Minas Gerais, Minas Gerais, Brazil.
Andrade
Rosires P
RP
Aldrighi
José M
JM
Guazelli
Cristina
C
Yazlle
Marta Edna H D
ME
Isaia
Carlos F
CF
Petracco
Alvaro
A
Peixoto
Fabio C
FC
Camargos
Aroldo F
AF
D000293:Adolescent; D000328:Adult; D000339:Affect / Q000187:drug effects*; D000736:Androstenes / Q000008:administration & dosage* / Q000009:adverse effects; D001794:Blood Pressure / Q000187:drug effects; D001826:Body Fluids / Q000187:drug effects*; D001835:Body Weight / Q000187:drug effects; D003267:Contraception; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage* / Q000009:adverse effects; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008597:Menstrual Cycle / Q000187:drug effects* / Q000523:psychology; D011293:Premenstrual Syndrome / Q000523:psychology*; D045167:Progesterone Congeners / Q000008:administration & dosage / Q000009:adverse effects
D000736:Androstenes; D003277:Contraceptives, Oral, Combined; D045167:Progesterone Congeners; D004997:Ethinyl Estradiol; C035144:drospirenone