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  • Title: Use of norethisterone and estradiol in mini doses as a contraceptive in the male. Efficacy studies in the adult male bonnet monkey (Macaca radiata).
    Author: Shetty G, Krishnamurthy H, Krishnamurthy HN, Ramachandra SG, Moudgal NR.
    Journal: Contraception; 1997 Oct; 56(4):257-65. PubMed ID: 9408708.
    Abstract:
    Administration of norethisterone (NET) or NET + estradiol benzoate using an Alzet minipump or as once-a-month intramuscular injection of their depot forms, NET-enanthate (NET-EN) and estradiol valerate (E-val), resulted in azoospermia in all monkeys (n = 13) within 60 to 150 days of treatment. Although addition of depot form of testosterone (T, 20 mg/month) to the regimen restored the behavioral response typical of a normal male, it did not reverse the azoospermic state. Serum T (heightened nocturnal) levels were significantly reduced (> 85%, p < 0.001) in all the treated groups. Evidence for blockade in spermatogenesis following treatment was obtained by DNA flow cytometry. Following withdrawal of treatment, the T level was restored to normalcy within 15 days but 120 days more were required for the animals to exhibit normal sperm counts. In conclusion, the efficacy of once-a-month injection of relatively low doses of NET-EN + E-Val to bring about azoospermia in monkeys, in a relatively short time, has been demonstrated. As the results are uniform and reproducible, it appears desirable that this steroid regimen be tested in man for its contraceptive efficacy. Monthly intramuscular injection with an Alzet minipump of depot norethisterone enanthate and estradiol valerate (E-val) produced azoospermia in 13 adult male bonnet monkeys within 60-150 days. Although azoospermia was achieved earlier when E-val was added to the injection, this agent can be eliminated once azoospermia occurs. Addition of the depot form of testosterone (20 mg/month) restored the sexual behavioral response but did not reverse azoospermia. Serum testosterone levels were significantly reduced in all treatment groups. DNA flow cytometry revealed evidence for blockade in spermatogenesis after treatment. There were no changes in the serum lipid profile. The testosterone level returned to normal within 15 days after the end of treatment, but normal sperm counts were not observed for another 120 days. Since the steroid formulation investigated in this study has been used effectively in women for over a decade, tests of its contraceptive efficacy in men now seem warranted.
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