Clinical trial of a monophasic estroprogestin oral formulation containing 20 micrograms ethinyl estradiol and 75 micrograms gestodene.
The attempt to decrease the hormonal components of combined estrogen/progestin-containing oral formulations has led to use of low-dose formulations. The monophasic formulation containing ethinyl estradiol 20 micrograms (EE20) plus gestodene 75 micrograms (GSD75) was studied in an open, non-comparative, multicenter, clinical trial investigating its efficacy, safety, effects on body weight, blood pressure and sexual function. To evaluate the impact on sexual function, the Golombok Rust Questionnaire on Sexual Satisfaction (GRISS) was used. The study population comprised 216 women treated for 1 year. The EE20/GSD75 formulation did not show any significant effect on blood pressure, hematological parameters, body weight or sexual function. The treatment was well tolerated with a high compliance rate by the patients, with a low rate of estrogen-dependent symptoms. Moreover, there was no overall effect on sexual function, with no disturbance of sexual behavior or activity. In conclusion, our data show that the EE20/GSD75 has a very good tolerability profile, without any significant side-effects.
Lello
S
S
Department of Obstetrics and Gynecology, University of Rome, Tor Vergata, Italy.
Monterubbianesi
M
M
Guardianelli
F
F
Bianchi
C
C
Simonelli
C
C
D000328:Adult; D001794:Blood Pressure; D001835:Body Weight; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004997:Ethinyl Estradiol / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007558:Italy; D009652:Norpregnenes / Q000008:administration & dosage*; D010349:Patient Compliance; D019529:Sexuality; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; D009652:Norpregnenes; C494367:estroprogestin; C033273:Gestodene; D004997:Ethinyl Estradiol