Andrologia-acesso aberto
Acesso livre
ISSN: 2167-0250
ISSN: 2167-0250
Radhey Shyam Sharma, Ajit Kumar Mathur, Hem Chandra Das, Balbir Singh Shah, Arvind Goyal, Kuldeep Chander Sharma, Subhash Abrol, Balram Sahoo, Nirmal Kumar Lohiya, Trilok Chand Sadasukhi
Objective: To obtain sufficient evidence about the efficacy and safety of an intravasal, injectable and non-hormonal male contraceptive RISUG® in a large number of healthy subjects. Method: Design-Prospective, straight, open-labelled and non-randomized, multi-center hospital-based phase-III clinical trial; Setting-Family planning clinics; departments of urology and surgery; Patients-Total of 303 healthy, sexually active and married male subjects (aged 25-40 years) and their healthy and sexually active wives; Injection(s)-A 60mg of RISUG® injected per vas deferens in a vehicle of 120 µ l dimethyl sulphoxide to male subjects only; Main outcome measure(s)-Overall efficacy of RISUG® with respect to achieving azoospermia was 97.3% and based on pregnancy prevention was 99.02% without any serious side effect. Results: Subjects achieved azoospermia ranged from 76.5% to 96.5% after 21 days of RISUG injection at various centers which reached to the highest level of 92.7%, 96.3% and 96.6% at 6 months post injection at Jaipur, New Delhi and Udhampur centers respectively and remained same till the last follow-up reported. In remaining two centers i.e. Kharagpur and Ludhiana, the subjects achieved 100% azoospermia at 6 week and 2.5 months postinjection respectively and the trend remained same till the last follow up reported. No serious adverse effect was reported both in RISUG® injected subjects and their wives till last follow up reported. Conclusion: RISUG® is a safe and highly efficacious male contraceptive without any serious side effects