Comparative study on the acceptability of two modern monophasic oral contraceptive preparations: 30 microgram ethinyl estradiol combined with 150 microgram desogestrel or 75 microgram gestodene.
Cycle control and tolerability of two monophasic oral contraceptive pills containing 30 microg ethinyl estradiol (EE) with either 150 microg desogestrel (DSG) or 75 microg gestodene (GSD) were compared in women starting oral contraception. A minimum of 200 healthy women at risk for pregnancy were to be treated for a total of 6 cycles per patient in a prospective, randomized open parallel-group multicenter trial. Two hundred and forty-one subjects were randomized, 115 to DSG/EE and 126 to GSD/EE. Compliance to the study preparation was high (around 95%) in both groups and no pregnancies occurred during the study. Cycle control was excellent; there were no differences between the two groups with regard to incidence of spotting and breakthrough bleeding or duration and intensity of withdrawal bleeding. Side-effects were mild and in general comparable in the two groups. Both at baseline and during treatment, a higher proportion of women taking GSD/EE complained about breast tenderness. This resulted in more early withdrawals because of breast tenderness in the GSD/EE group. It was concluded that monophasic DSG/EE and GSD/EE are equally effective, have similar cycle control and both are generally well tolerated.
Zichella
L
L
Clinica Ostetrica e Ginecologia, Universita degli Studi, La Sapienza, Roma, Italy.
Sbrignadello
C
C
Tomassini
A
A
Di Lieto
A
A
Montoneri
C
C
Zarbo
G
G
Mancone
M
M
Pietrobattista
P
P
Bertoli
G
G
Perrone
G
G
D000293:Adolescent; D000328:Adult; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage* / Q000009:adverse effects; D003278:Contraceptives, Oral, Hormonal / Q000008:administration & dosage* / Q000009:adverse effects; D017135:Desogestrel / Q000008:administration & dosage* / Q000009:adverse effects; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008597:Menstrual Cycle; D009652:Norpregnenes / Q000008:administration & dosage* / Q000009:adverse effects; D045167:Progesterone Congeners / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies
D003277:Contraceptives, Oral, Combined; D003278:Contraceptives, Oral, Hormonal; D009652:Norpregnenes; D045167:Progesterone Congeners; C033273:Gestodene; D004997:Ethinyl Estradiol; D017135:Desogestrel