Phase-III Clinical Trial with an Intravasal Injectable Male Contraceptive â?? RISUGÂ® - RISUG

Indian Council of Medical Research0 个研究点目标入组 303 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

•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.

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