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Submitted on June 27, 2004
Accepted on October 18, 2004
Prince Henry's Institute of Medical Research & Department of Obstetrics and Gynaecology, Monash University, Monash Medical Centre, Clayton, Victoria, 3168, Australia, The Center for Research in Reproduction and Contraception, University of Washington, Seattle, Washington, 98195, USA and School of Physiotherapy, University of Melbourne, Parkville, Victoria, 3010, Australia
* To whom correspondence should be addressed.
Kati L. Matthiesson, E-mail: kati.matthiesson{at}phimr.monash.edu.au
We postulated that the addition of a combined type I and II, 5 
reductase inhibitor (dutasteride) or long acting GnRH antagonist (acyline) to combination testosterone plus levonorgestrel treatment may be advantageous in the suppression of spermatogenesis for male contraception. This study aimed to examine effects of novel combination contraceptive regimens on serum gonadotropins and androgens and sperm concentration.
This study was divided into three phases; screening (two weeks), treatment (eight weeks) and recovery (four weeks). Twenty-two men (n = 5-6/group) received 8 weeks of treatment with testosterone enanthate (TE, 100 mg IM weekly) combined with either (i) levonorgestrel (LNG) 125mcg orally daily or (ii) LNG 125 mcg plus dutasteride 0.5 mg orally daily or (iii) acyline 300mcg/kg sc every 2 weeks (as a comparator for any additional progestin effects) or (iv) LNG 125 mcg orally daily plus acyline 300mcg/kg sc every two weeks.
Serum gonadotropin levels were similarly suppressed by all treatments falling to a nadir between 1.2-3.4% and 0.5-0.8% baseline for FSH and LH respectively, P < 0.05. Serum DHT levels were significantly (P < 0.05) decreased in the dutasteride group throughout the treatment period to a nadir of 31% baseline (week 7). No significant differences in sperm concentrations between treatment groups were seen. Severe oligospermia (0.1-3million/ml) or azoospermia was seen in 0/5 and 4/5 in TE + LNG; 2/6 and 4/6 in TE + LNG + dutasteride; 2/6 and 4/6 in TE + acyline; and 1/5 and 3/5 in TE + LNG + acyline groups respectively. There was one non-responder in each of the TE + LNG and T + LNG + acyline groups.
We conclude that the addition of a combined type I and II, 5 reductase inhibitor or long acting GnRH antagonist to a T plus LNG regimen provides no additional suppression of gonadotropins or sperm concentration over an 8 week treatment period. However further evaluation of the effects of these regimens on the testis (including testicular steroid levels and germ cell maturation), and the treatment of larger numbers of men (and for longer periods) may provide data to support their place in contraceptive development.
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