Gajanan S Bhat1, Anuradha Shastry2. 1. Sexual Medicine, TSS Shripad Hegde Kadave Institute of Medical Sciences, A-1, Doctor's Quarters, Sirsi, Karnataka, 581402, India. gajubhatru@gmail.com. 2. Department of Urology, Andrology and Sexual Medicine, TSS Shripad Hegde Kadave Institute of Medical Sciences, Sirsi, Karnataka, India.
Abstract
PURPOSE: As silodosin 8 mg, used for treating BPH, is known to cause absence of sperms in the ejaculate, its potential as an on-demand, reversible, nonhormonal oral contraceptive for males was assessed in this pilot study. METHODS: In this randomized, double-blind, placebo-controlled pilot study, healthy, sexually active adult male volunteers in a stable sexual relationship with a female partner with proven fertility were recruited. Those using other contraceptive methods were excluded. During the first part of the study, silodosin 8 mg and placebo were crossed over among the randomly assigned two groups of participants and their post-masturbation semen and post-ejaculation urine were analyzed for spermatozoa. During the second part, both groups received silodosin 8 mg 3 h prior to heterosexual vaginal intercourse for 1 year. The primary outcome measure was the number of unintended pregnancies in their female partners. The secondary outcome measure was dropout rate due to adverse events. The clinical trial registry number was CTRI/2017/09/009872. RESULTS: The study period was January 2017 to December 2017 with sample size 63. Reversible azoospermia was noted following silodosin intake during the first part of the study. During the second part, no untended pregnancy was reported. None of the participants dropped out due to adverse events. Four patients were lost to follow-up. CONCLUSIONS:Silodosin 8 mg achieved total reversible azoospermia, hence prevented unintended pregnancies in the female partners of the males who used the drug as an on-demand oral contraceptive.
RCT Entities:
PURPOSE: As silodosin 8 mg, used for treating BPH, is known to cause absence of sperms in the ejaculate, its potential as an on-demand, reversible, nonhormonal oral contraceptive for males was assessed in this pilot study. METHODS: In this randomized, double-blind, placebo-controlled pilot study, healthy, sexually active adult male volunteers in a stable sexual relationship with a female partner with proven fertility were recruited. Those using other contraceptive methods were excluded. During the first part of the study, silodosin 8 mg and placebo were crossed over among the randomly assigned two groups of participants and their post-masturbation semen and post-ejaculation urine were analyzed for spermatozoa. During the second part, both groups received silodosin 8 mg 3 h prior to heterosexual vaginal intercourse for 1 year. The primary outcome measure was the number of unintended pregnancies in their female partners. The secondary outcome measure was dropout rate due to adverse events. The clinical trial registry number was CTRI/2017/09/009872. RESULTS: The study period was January 2017 to December 2017 with sample size 63. Reversible azoospermia was noted following silodosin intake during the first part of the study. During the second part, no untended pregnancy was reported. None of the participants dropped out due to adverse events. Four patients were lost to follow-up. CONCLUSIONS:Silodosin 8 mg achieved total reversible azoospermia, hence prevented unintended pregnancies in the female partners of the males who used the drug as an on-demand oral contraceptive.
Entities:
Keywords:
Alfa blockers; Contraception; Male methods; Silodosin
Authors: Carl W White; Yan-Ting Choong; Jennifer L Short; Betty Exintaris; Daniel T Malone; Andrew M Allen; Richard J Evans; Sabatino Ventura Journal: Proc Natl Acad Sci U S A Date: 2013-12-02 Impact factor: 11.205
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