A double-blind comparison of the efficacy and acceptability of Femodene and Microgynon-30.
The efficacy, cycle-control and tolerance of Microgynon-30, a widely prescribed levonorgestrel containing oral contraceptive, and Femodene, a new oral-contraceptive containing gestodene, were compared in a randomised, double-blind study involving 456 healthy women over a 6 month period. 229 women were allocated to receive Femodene and 227 received Microgynon-30. No differences between the groups in terms of obstetric and gynaecological history, previous contraceptive history, smoking habits, blood-pressure or body weight at admission were observed. No pregnancies were reported in either group, despite tablet-taking errors recorded in 6.3% of the Femodene group and 7.6% of the Microgynon-30 group. Both oral contraceptives were compared in terms of cycle length, intensity of the withdrawal bleed and side effects. Cycle-control was similar in the two groups. However, significantly fewer subjects reported breakthrough bleeding (with or without spotting) in the Femodene group (18% of patients) compared with the Microgynon-30 group (26% of patients). The incidence of absent withdrawal bleeds was 1% or less in both groups and no significant effects on body weight or blood pressure were observed.
Loudon
N B
NB
Family Planning Clinic, Edinburgh, U.K.
Kirkman
R J
RJ
Dewsbury
J A
JA
D000293:Adolescent; D000328:Adult; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects; D019304:Ethinyl Estradiol-Norgestrel Combination; D005260:Female; D006801:Humans; D006973:Hypertension / Q000139:chemically induced; D008597:Menstrual Cycle; D015337:Multicenter Studies as Topic; D009644:Norgestrel / Q000008:administration & dosage* / Q000009:adverse effects; D009652:Norpregnenes / Q000008:administration & dosage* / Q000009:adverse effects; D010352:Patient Dropouts; D011897:Random Allocation; D006113:United Kingdom
D003277:Contraceptives, Oral, Combined; D009652:Norpregnenes; C055368:Femovan; C033273:Gestodene; D009644:Norgestrel; D004997:Ethinyl Estradiol; D019304:Ethinyl Estradiol-Norgestrel Combination