Andrologie- Offener Zugang
Offener Zugang

Abstrakt

Phase-III Clinical Trial with an Intravasal Once Injectable Non-Hormonal Male Contraceptive-Reversible Inhibition of Sperm under Guidance (RISUG)

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