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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
INTRODUCTION
Combined oral contraceptives (COCs) are a popular and highly effective form of reversible contraception. The bleeding pattern with COCs is generally cyclical, with the oestrogen component providing a dosedependent effect on cycle control. A disadvantage of COCs is that oestrogens may induce unwanted effects, which preclude their use in certain groups of women, such as those with risk factors for arterial and venous thrombotic events, and lactating women ' . The use of oestrogens may be associated with breast tenderness, bloating and nausea, which often cause women to discontinue COCs . Headaches can also be related to oestrogen exposure, both during pill taking and after hormone withdrawal in the pill-free interval .
Oestrogen-free contraception provides a good alternative for these women. The older, traditional progestogen-only pills (POPs) have some disadvantages, such as inconsistent ovulation inhibition and thus lower contraceptive efficacy, an increased risk of ectopic pregnancy , and unwanted androgenic side effects (since many preparations...