National Institute of Medical Statistics, Indian Council of Medical Research, New Delhi, India
Research Article
Phase-III Clinical Trial with an Intravasal Once Injectable Non-Hormonal Male Contraceptive-Reversible Inhibition of Sperm under Guidance (RISUG)
Author(s): Radhey Shyam Sharma*, Ajit Kumar Mathur, Hem Chandra Das, Balbir Singh Shah, Arvind Goyal, Kuldeep Chander Sharma, Subhash Abrol, Balram Sahoo, Nirmal Kumar Lohiya and 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%.. View More»
DOI:
10.35248/2167-0269.23.12.297