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

Abstract

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.

Key words:

• Oestrogen-free
• Desogestrel
• Oral contraceptive
• Cyclical symptoms
• Side effects
• Dysmenorrhoea
• Observational study