None listed
Conditions
Interventions
Intervention1: RISUG: The drug is a specific copolymer of styrene with maleic anhydride dissolved in a solvent vehicle of dimethyl sulphoxide. The basic drug, styrene maleic anhydride (SMA) is to be p
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age at the time of induction to be in the range 25 - 40 years 2. Have two or more normal healthy living children 3. Be in good health 4. Normal reproductive system and semen parameters (determined by clinical examination and laboratory investigations) 5. Wife healthy 6. Wife not pregnant at the time of induction of the male into the programme (pregnancy to be excluded by menstrual history, clinical examination and if necessary pregnancy test) 7. Wife has not undergone sterilization operation 8. In case wife has an intrauterine device she should agree to removal of the IUD when the male partner is inducted into the programme. 9. The couple should agree to avoid the use of any contraceptives other than what is advised during the study and in case of conception they should be prepared to undergo Medical Termination of Pregnancy. 10. Couple willing to follow the follow up schedule and will undergo all the clinical and laboratory examinations 11. For convenience in follow-up, as far as possible the subjects are to be taken from areas close to the trial centre.
Exclusion criteria
Exclusion criteria: 1. Sexually transmitted disease in either partner 2. Impotence 3. Any psychiatric disorders like anxiety problem 4. Chronic pelvic infection or cervical carcinoma of wife 5. Diabetes Mellitus 6. Any pathology including diseases, which may interfere with the action of the contraceptive agent, induce complications or introduce variables, which may bring in ambiguities in the interpretation of the observations. For example azoospermia or oligozoospermia, cryptorchidism, testicular atrophy, testicular tumors, epididymo-orchitis, cysts and spermatocele related to the epididymis, varicocele, palpably hypertrophied vas deferens, any indications of tuberculosis of the vas deferens etc. 7. Pre-existing vaginitis, cervicitis and cervical dysplasia may be wrongly attributed to such an implantation of the polymer into the female system. Vaginitis, cervicitis and cervical dysplasia are to be treated but those with cervical carcinoma in situ and advanced grades of carcinoma are to be excluded. 8. The male partners of the women having tuberculosis of the reproductive organs, fibroid and other gynecological problems, which may later affect the pregnancy, also have to be eliminated. 9. Wife is not willing to undergo periodic pregnancy test if advised.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To obtain sufficient evidence about the safety and efficacy of the RISUG in large number of Healthy male subjects.Timepoint: approximately after 3 weeks of injection | — |
Secondary
| Measure | Time frame |
|---|---|
| Any adverse eventTimepoint: during and after the injection | — |
Countries
India
Contacts
Public ContactDr R S Sharma
Indian council of Medical Research
Outcome results
None listed