Safety & efficacy of an intravasal, one-time injectable & non-hormonal male contraceptive (RISUG): A clinical experience

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dc.contributor.authorSharma, RSen_US
dc.contributor.authorMathur, AKen_US
dc.contributor.authorSingh, Ren_US
dc.contributor.authorDas, HCen_US
dc.contributor.authorSingh, GJen_US
dc.contributor.authorToor, DPen_US
dc.contributor.authorGuha, SKen_US
dc.date.accessioned2020-04-10T01:43:28Z
dc.date.available2020-04-10T01:43:28Z
dc.date.issued2019-07
dc.description.abstractBackground & objectives: For improved male contraception, a new polymeric drug molecule – Reversible Inhibition of Sperm under Guidance (RISUG) has been synthesized and has been found to be effective, safe and reversible in various animal species. Phase-I and phase-II clinical trials have confirmed its safety and contraceptive efficacy. The present study was undertaken as a multicentric-limited phase-III clinical trial to test the efficacy and safety of RISUG in human volunteers. Methods: One hundred and thirty nine young males each having at least two children and living with wife were given 120 ?l of RISUG as bilateral vas intraluminal injection. After the single-dose administration, the individuals were followed in respect of general health and semen parameters. Their wives were also followed particularly to determine onset of pregnancy. Results: During the six month follow up, the health of male volunteers and their wives was normal with no significant adverse effects. Temporary scrotal enlargement and mild scrotal and inguinal region pain were manifested in most individuals and resolved within one month without any routine activity impairment. In six individuals, there was injection procedure failure and azoospermia was not achieved. The other 133 individuals had either severe oligozoospermia or azoospermia at the first semen examination one month following RISUG injection; 82.7 per cent individuals had continued azoospermia in the month following first semen examination onwards and the rest 17.3 per cent manifested azoospermia within three to six months. Interpretation & conclusions: RISUG intravasal injection appears to be a safe clinical procedure with no significant adverse effects and has high sustained contraceptive efficacy. The localized intervention and continued contraceptive action on single-dose administration were significant features of the RISUG technology.en_US
dc.identifier.affiliationsDivision of Reproductive Biology, Maternal Health and Child Health, Indian Council of Medical Research, New Delhi, Indiaen_US
dc.identifier.affiliationsMale Family Planning Clinic, Lok Nayak Jai Parkash Narayan Hospital, Delhi, Indiaen_US
dc.identifier.affiliationsDepartment of Surgery, Deen Dayal Upadhyay Hospital, New Delhi, Indiaen_US
dc.identifier.affiliationsDepartment of Surgery, Rural Medicare Center Hospital, New Delhi, Indiaen_US
dc.identifier.affiliationsSchool of Medical Science & Technology, Indian Institute of Technology, Kharagpur, Indiaen_US
dc.identifier.citationSharma RS, Mathur AK, Singh R, Das HC, Singh GJ, Toor DP, Guha SK. Safety & efficacy of an intravasal, one-time injectable & non-hormonal male contraceptive (RISUG): A clinical experience. Indian Journal of Medical Research. 2019 Jul; 150(1): 81-86en_US
dc.identifier.issn0971-5916
dc.identifier.issn0975-9174
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/195951
dc.languageenen_US
dc.publisherIndian Council of Medical Researchen_US
dc.relation.issuenumber1en_US
dc.relation.volume150en_US
dc.source.urihttps://dx.doi.org/10.4103/ijmr.IJMR_635_18en_US
dc.subjectAzoospermiaen_US
dc.subjectefficacyen_US
dc.subjectintravasal male contraceptiveen_US
dc.subjectRISUGen_US
dc.subjectsafetyen_US
dc.subjectspermen_US
dc.titleSafety & efficacy of an intravasal, one-time injectable & non-hormonal male contraceptive (RISUG): A clinical experienceen_US
dc.typeJournal Articleen_US
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