Clinical findings with the oral contraceptive combination ethinylestradiol/dienogest in the Czech Republic.
The efficacy and safety of the low dose monophasic oral contraceptive (OC) combination containing 30 micrograms of ethinylestradiol (EE) and 2.0 mg of dienogest (DNG) (EE/DNG) was evaluated in a prospective, open-label, multicenter, uncontrolled, phase III trial. The trial was carried out in six hospitals by 36 investigators in the Czech Republic, and included 557 healthy women (aged 18-35 years), over 12 cycles, with a total of 6051 cycles. EE/DNG provided a reliable ovulation inhibition. The contraceptive efficacy study showed an adjusted Pearl index of 0.198 on the basis of three pregnancies occurring during 6051 cycles. EE/DNG provided good cycle control, reduced the incidence of intermenstrual bleedings, the intensity of menstrual bleeding and frequency of dysmenorrhea. Due to the antiandrogenic properties of the progestogen component DNG, EE/DNG improved androgen-related conditions, such as skin blemishes, hair greasiness and acne vulgaris. From 108 women with acne, 62 (57%) improved after the 6th cycle, and 16 (15%) were healed. Similar changes were found after cycle 12. Breast tenderness and headache were the most frequent of the common complaints due to treatment with EE/DNG. The frequency of all complaints decreased steadily over time. Only 7.7% of subjects discontinued due to adverse reactions. No thrombophlebitic events were noticed.
Golbs
S
S
Department of Medical Affairs, Jenapharm GmbH & Co. KG, Jena, Germany. Siegfried.Golbs@Jenapharm.de
Domhardt
R
R
Presl
J
J
Ganev
M
M
Wisser
K H
KH
Zimmermann
T
T
D000293:Adolescent; D000328:Adult; D001941:Breast Diseases / Q000139:chemically induced; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D019363:Cytochrome P-450 CYP1A1 / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003863:Depression / Q000139:chemically induced; D004334:Drug Administration Schedule; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006261:Headache / Q000139:chemically induced; D006801:Humans; D009277:Nandrolone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D011446:Prospective Studies; D012871:Skin Diseases / Q000139:chemically induced; D013250:Steroid Hydroxylases / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017211:Treatment Failure; D016896:Treatment Outcome
D003277:Contraceptives, Oral, Combined; C023635:dienogest; D009277:Nandrolone; D013250:Steroid Hydroxylases; D019363:Cytochrome P-450 CYP1A1; C020120:estrogen 2-hydroxylase