Hum. Reprod. Advance Access published online on July 3, 2007
Human Reproduction, doi:10.1093/humrep/dem177
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A novel estrogen-free oral contraceptive pill for women: multicentre, double-blind, randomized controlled trial of mifepristone and progestogen-only pill (levonorgestrel)
1 Centre for Reproductive Biology, Simpson Centre for Reproductive Health, University of Edinburgh, 51 Little France Crescent, Edinburgh EH16 4SA, UK 2 Department of Obstetrics and Gynaecology, Queen Mary Hospital, The University of Hong Kong, Pokfulam Road, Hong Kong 3 Department of Obstetrics and Gynaecology, University of Cape Town Medical School, Anzio Road, Observatory 7925, South Africa 4 Centre for Research in Reproductive Health, Obafemi Awolowo College of Health Services, Ogun State University Teaching Hospital, PMB 2001 Sagamu, Nigeria 5 School of Clinical Sciences and Community Health, University of Edinburgh, Teviot Place, Edinburgh EH8 9AG, UK 6 NHS Lothian Family Planning and Well Woman Services, 18 Dean Terrace, Edinburgh EH4 1NL, UK 7 Centre for Reproductive Biology, University of Edinburgh, The Queen's Medical Research Institute, 47 Little France Crescent, Edinburgh EH16 4TJ, UK 8 Department of Pathology, University of Edinburgh, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh EH16 4SA, UK
9 Correspondence address. Tel: +44 131 242 6367; Fax: +44 131 242 2686; E-mail: dtbaird{at}ed.ac.uk
BACKGROUND: The acceptability and continuation rate of oral contraceptive steroids are limited by unpredictable bleeding and the fear of long-term risks such as breast cancer. By inhibiting ovulation and by altering the receptivity of the endometrium, antagonists of progesterone, such as mifepristone, could be developed as estrogen-free novel contraceptives.
METHODS: Multicentre, double-blind, randomized controlled trial comparing frequency of amenorrhoea (primary outcome), bleeding patterns, side effects and efficacy in women taking daily 5 mg mifepristone (n = 73) or 0.03 mg levonorgestrel (progestogen-only pill; POP, n = 23) for 24 weeks.
RESULTS: More women were amenorrhoeic while taking mifepristone than POP (49 versus 0% P < 0.001), and fewer women bled or spotted for >5 days per month (4 versus 39% P < 0.001). Forty-eight percent of women who took mifepristone for 6 months had cystic glandular dilatation of the endometrium but none showed hyperplasia or atypia. There were no pregnancies in 356 months of exposure in women who used only mifepristone for contraception. Two pregnancies occurred in women taking mifepristone who were also using condoms for dual protection.
CONCULSIONS: Daily mifepristone (5 mg) is an effective oral contraceptive pill which has a better pattern of menstrual bleeding than an existing POP (levonorgestrel).
Key words: antiprogestins/contraception/levonorgestrel/mifepristone/progestogen-only pill
Submitted on September 28, 2006; resubmitted on April 30, 2007; accepted on May 23, 2007.
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