The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception · 2007
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.
Сравнительное исследованиеСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Ahrendt Hans-Joachim, Karckt Ulrich, Pichl Tanja, Mueller Thomas, Ernst Uwe
Аннотация
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 (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.
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.