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

• Published in: The European journal of contraception & reproductive health care 2007-12, Vol.12 (4), p.354-361
• Main Authors: Ahrendt, Hans-Joachim, Karck, Ulrich, Pichl, Tanja, Mueller, Thomas, Ernst, Uwe
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Birth control; Breast; Changes; Clinical medicine; Contraceptives, Oral, Hormonal - adverse effects; Contraceptives, Oral, Synthetic - pharmacology; Cyclical symptoms; Desogestrel; Desogestrel - pharmacology; Dysmenorrhea - drug therapy; Dysmenorrhoea; Edema - drug therapy; Edema - etiology; Estrogens; Estrogens - adverse effects; Female; Headache - drug therapy; Headache - etiology; Headaches; Humans; Menstrual Cycle - drug effects; Middle Aged; Nausea; Nausea - drug therapy; Nausea - etiology; Observational study; Oestrogen-free; Oral contraceptive; Patient Satisfaction; Prospective Studies; Risk factors; Side effects; Studies; Women
• ISSN: 1362-5187; 1473-0782
• DOI: 10.1080/13625180701536771

Objectives 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 (∼90%) and wished to continue treatment after study completion (∼85%). Conclusions Cerazette® in this study set-up improved oestrogen-related symptoms and dysmenorrhoea in women affected and treatment was well accepted.