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Human Reproduction, Vol. 18, No. 1, 69-76, January 2003
© 2003 European Society of Human Reproduction and Embryology

Low-dose antiprogestin treatment prevents pregnancy in rhesus monkeys and is reversible after 1 year of treatment

S.M. Borman1, K.M. Schwinof1, C. Niemeyer2, K. Chwalisz3,5, R.L. Stouffer1,4 and M.B. Zelinski-Wooten1,4,6

Divisions of 1 Reproductive Sciences and 2 Animal Resources, Oregon National Primate Research Center, Beaverton, OR 97006 USA, 3 Fertility Control and Hormone Therapy Research, Research Laboratories of Schering AG, D13342 Berlin, Germany and 4 Department of Physiology and Pharmacology, Oregon Health & Science University, Portland, OR 97201, USA 5 Present address: TAP Pharmaceutical Products, 675 N. Field Dr., Lake Forest, IL 60045, USA 6 To whom correspondence should be addressed at: Oregon National Primate Research Center, 505 N.W. 185th Ave, Beaverton, Oregon 97006, USA. e-mail: zelinski{at}ohsu.edu

BACKGROUND: Administration of low doses of an antiprogestin to rhesus monkeys permits ovarian/menstrual cyclicity, suppresses endometrial proliferation and prevents pregnancy without adverse or toxic side-effects after 5–6 months of daily treatment. The purpose of this study was to test the reversibility with respect to restoration of fertility after 1 year of low-dose antiprogestin treatment. METHODS: This experiment included a daily 1 year vehicle- or antiprogestin-treatment interval followed by a 9 month post-treatment interval for adult, female rhesus monkeys (n = 5/group) of proven fertility and exhibiting regular menstrual cycles. Co-habitation occurred with a male of proven fertility and vaginal swabs were taken to identify the presence of sperm during the treatment (antiprogestin females) and post-treatment intervals (vehicle and antiprogestin females). RESULTS: Mating and vaginal sperm were evident in all antiprogestin females during, and, in both groups, after treatment. Based on ultrasonography, none of the antiprogestin-treated females became pregnant during the treatment interval. However, upon cessation of treatment, pregnancy rates were similar between antiprogestin-treated (3/5) relative to vehicle-treated (4/5) females with live, healthy infants born in both groups. There were no differences between groups in fetal measurements, gestation lengths, live birth rates and infant weights. CONCLUSIONS: The reversal of the anti-fertility effects of chronic, low-dose antiprogestin treatment supports the clinical feasibility of potent and selective antiprogestins as potential contraceptives for women.

Key words: antiprogestin/contraception/pregnancy/reversibility/ZK 137 316


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