The effects of an oestrogen-free, desogestrel-containing oral contraceptive in women with cyclical symptoms: results from two studies on oestrogen-related symptoms and dysmenorrhoea.
OBJECTIVE
To evaluate the effects of an oestrogen-free oral contraceptive (Cerazette; 75 mcg/day desogestrel) in women with oestrogen-related symptoms during previous combined oral contraceptive (COC) use (ERS study) and in women with dysmenorrhoea (DYS study).


METHODS
Two similarly designed prospective, non-comparative multicentre observational studies were carried out in Germany. Altogether, 403 women with oestrogen-related symptoms during previous COC use and 406 women with dysmenorrhoea took Cerazette continuously. Symptom-related assessments were made at baseline and after 3-4 months, along with bleeding pattern and treatment satisfaction.


RESULTS
In the ERS study, the four oestrogen-related symptoms studied resolved or improved in over 70% of women. Nausea improved/resolved most (92% of women), followed by breast tenderness (90%), oestrogen-related headache (84%) and oedema (74%). In the DYS study, dysmenorrhoea resolved or considerably improved in 93% of the study population. Correspondingly, use of analgesics dropped from 70% of women at baseline to 8% at study end. Adverse events were reported by 7-8% of both study populations and were mainly bleeding irregularities. Most women in both studies were satisfied with treatment (approximately 90%) and wished to continue treatment after study completion (approximately 85%).


CONCLUSIONS
Cerazette in this study set-up improved oestrogen-related symptoms and dysmenorrhoea in women affected and treatment was well accepted.
Ahrendt
Hans-Joachim
HJ
Klinikum Stuttgart, Frauenklinik, Stuttgart, Germany.
Karckt
Ulrich
U
Pichl
Tanja
T
Mueller
Thomas
T
Ernst
Uwe
U
D000293:Adolescent; D000328:Adult; D001940:Breast; D003278:Contraceptives, Oral, Hormonal / Q000009:adverse effects*; D003280:Contraceptives, Oral, Synthetic / Q000494:pharmacology*; D017135:Desogestrel / Q000494:pharmacology*; D004412:Dysmenorrhea / Q000188:drug therapy*; D004487:Edema / Q000188:drug therapy / Q000209:etiology; D004967:Estrogens / Q000009:adverse effects; D005260:Female; D006261:Headache / Q000188:drug therapy / Q000209:etiology; D006801:Humans; D008597:Menstrual Cycle / Q000187:drug effects*; D008875:Middle Aged; D009325:Nausea / Q000188:drug therapy / Q000209:etiology; D017060:Patient Satisfaction; D011446:Prospective Studies
D003278:Contraceptives, Oral, Hormonal; D003280:Contraceptives, Oral, Synthetic; D004967:Estrogens; D017135:Desogestrel