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DOI 10.3109/13625187.2015.1044082

Медицинская библиотека · The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception · 2015

A randomised study comparing the effect on ovarian activity of a progestogen-only pill (POP) containing desogestrel and a new POP containing drospirenone in a 24/4 regimen.

Duijkers Ingrid J M, Heger-Mahn Doris, Drouin Dominique, Skouby Sven

Клиническое исследование II фазыСравнительное исследованиеСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАПеревод в очереди

Аннотация

OBJECTIVES

Progestogen-only pills (POPs) are safer with respect to cardiovascular risks than contraceptives containing estrogens. Despite the increased contraceptive efficacy of a desogestrel-only pill compared with a traditional POP, POPs are still not widely used due to an unpredictable bleeding pattern. A new POP containing 4 mg drospirenone has been developed with a 24/4 intake regimen which may improve the bleeding pattern. The objectives of this study were to investigate ovulation inhibition with the new drospirenone-only pill in comparison with the desogestrel-only pill and, in addition, to assess the effects on cervical mucus permeability and bleeding.

METHODS

Sixty-four healthy volunteers with proven ovulatory cycles were randomised and treated with either the drospirenone-only or the desogestrel-only pill during two 28-day cycles. Follicular diameter, endometrial thickness, and serum estradiol (E2) and progesterone concentrations were measured and Hoogland scores were determined. Additionally, cervical mucus scores, bleeding and return of ovulation were assessed.

RESULTS

Both treatments effectively inhibited ovulation. Follicular diameter, E2 levels and Hoogland scores were equal, demonstrating efficient ovarian suppression. One subject in each group had a Hoogland score of 6, but the criteria for normal luteal activity were not fulfilled. In both groups, ovulation did not occur before day 9 of the post-treatment cycle. Cervical mucus permeability was suppressed in both groups. The median number of bleeding and spotting days was lower in the drospirenone group.

CONCLUSIONS

The new drospirenone-only pill inhibited ovulation as effectively as the desogestrel-only pill despite the 4-day hormone-free interval.

Для цитирования: Duijkers Ingrid J M, Heger-Mahn Doris, Drouin Dominique, Skouby Sven. A randomised study comparing the effect on ovarian activity of a progestogen-only pill (POP) containing desogestrel and a new POP containing drospirenone in a 24/4 regimen.. The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception. 2015. DOI: 10.3109/13625187.2015.1044082.

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