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This experimental male contraceptive regimen was developed and studied by the University of Washington in a Phase 2 clinical trial (NCT00842751). The regimen consists of a three-drug combination: acyline, a gonadotropin-releasing hormone (GnRH) antagonist; testosterone undecanoate (TU), an androgen ester; and finasteride, a 5α-reductase inhibitor. The mechanism involves using acyline to suppress the hypothalamic-pituitary-gonadal axis, which inhibits endogenous testosterone production and spermatogenesis to induce a temporary state of infertility. To mitigate the resulting hypogonadism, a novel oral formulation of testosterone undecanoate is co-administered as androgen replacement therapy. The specific 'Third Intervention' arm of the study evaluated the pharmacokinetics of this oral TU formulation when combined with a 1.0 mg twice-daily dose of finasteride, which blocks the conversion of testosterone to dihydrotestosterone (DHT). This allows researchers to investigate the necessity of DHT for the hormonal feedback loops and physiological effects required for effective male contraception.
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