A randomized, double-blind, noninferiority study to compare two regimens of levonorgestrel for emergency contraception in Nigeria☆☆☆
Received 17 February 2010; received in revised form 30 May 2010; accepted 2 June 2010. published online 20 July 2010. Corrected Proof
Abstract
Background
Unplanned pregnancies are common in Nigeria. Much of the unplanned pregnancies is due to low contraceptive prevalence and high contraceptive user failure rates. High user failure rates suggest the important role of emergency contraception to prevent unplanned pregnancy.
Study Design
Randomized, controlled, double-blind, multicenter, noninferiority trial comparing efficacy and side effects of two emergency contraceptive regimens up to 5 days after unprotected intercourse among 3022 Nigerian women: levonorgestrel administered in two doses of 0.75 mg given 12 h apart and levonorgestrel administered in a single dose of 1.5 mg.
Results
Efficacy was similar between the treatment groups; post-treatment pregnancy proportions were 0.57% in the two-dose regimen vs. 0.64% in the single-dose regimen (risk difference 0.07% (95% CI −0.50 to 0.64). The majority of women menstruated the first day of expected menses and the groups did not differ regarding reported side effects.
Conclusions
This study shows the simplified emergency contraceptive regimen of single-dose levonorgestrel is not inferior in efficacy to the two-dose regimen among Nigerian women.
aCentre for Research in Reproductive Health, Olabisi Onabanjo University Teaching Hospital, Sagamu, 121001 Ogun State, Nigeria
bDepartment of Family Medicine and Community Health Sciences, University of Illinois at Chicago, IL 60612, USA
cUNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, 1211 Geneva 27, Switzerland
Corresponding author.
☆ Clinical Trial Registration: current controlled trials, isrctn.org, ISRCTN69287540.
☆☆ This study was funded by UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction.
1 Investigators and study centres of the Nigerian National Network for Reproductive Health Research and Training: Women's Health and Action Research Centre, Benin: F.E. Okonofua, G. Eguzoro; University of Nigeria Teaching Hospital, Enugu: John Okaro, C. Anumba; University College Hospital, Ibadan: Y. Adekunle, Bola Bello; University of Jos Teaching Hospital, Jos: J.A.M. Otubu, N. Izzah; Lagos University Teaching Hospital, Lagos: Bomi Ogedengbe, C. Osifoh; University of Port-Harcourt: Victor Wakwe, K.M. Jonathan; Olabisi Onabanjo University Teaching Hospital, Sagamu: O.L. Odusoga, B. Idowu-Ajiboye, Toyin Aina, K. Oritogun.
ABSTRACT