Human Reproduction, Vol. 17, No. 10, 2588-2593,
October 2002
© 2002 European Society of Human Reproduction and Embryology
Improving cycle control in progestogen-only contraceptive pill users by intermittent treatment with a new anti-progestogen
1 Department of Woman and Child Health, Division for Obstetrics and Gynaecology, Karolinska Hospital/Institute, Stockholm, Sweden, 2 Department of Obstetrics and Gynecology, Dijkzigt University Hospital, Rotterdam, The Netherlands, 3 Department of Gynecology, The Princess Royal Hospital, Hull, UK, 4 Instituto Chileno de Medicina Reproductiva, Santiago de Chile, Chile, 5 Service d'Endocrinologie, Hopital Saint-Antoine, Paris, France and 6 Department of Obstetrics and Gynecology, University of Edinburgh, Edinburgh, UK
BACKGROUND: The safety and efficacy of the anti-progestogen Org 31710 in improving cycle control in healthy women using the desogestrel progestogen-only pill was investigated in this randomized, double-blind, placebo-controlled study. METHODS: A total of 103 women using the 75 µg desogestrel progestogen-only pill daily also received either 150 mg Org 31710 or placebo once every 28 days, starting on day 1, for a duration of 4–7 treatment cycles. RESULTS: The percentage of women with bleeding or spotting (B/S) every day in the placebo group was on average 30% during the whole treatment period and no days without reported B/S occurred. In contrast, a cyclic pattern was observed for the Org 31710 group; a peak incidence of B/S was observed on day 3 or 4 of each cycle, followed by a sharp decrease on cycle days 9–15. Compared with controls, less subjects in the Org 31710 group reported irregular, frequent or prolonged bleeding. These differences were clearly observed in the initial cycles, but were somewhat less pronounced during the later cycles of the treatment period. A relatively high incidence of B/S episodes starting in the second section of the cycle was also observed. CONCLUSION: The addition of Org 31710 once a month improved cycle control in women using daily treatment with 75 µg desogestrel.
Key words: anti-progestogens/cycle control/progestogen-only pill
7 To whom correspondence should be addressed. E-mail: kristina.gemzell-danielsson{at}ks.se
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