Sildosin as a Male Contraceptive Non Hormonal

Benha University

Status and phase: Not yet enrolling; Phase 1

Conditions: Contraception Use

Treatments: Drug: Oral intake of sildosin; Other: Oral intake of placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07195097

RC 5-10-2024

Details and patient eligibility

About

In all, 200 healthy, sexually active, fertile male candidates will be assigned 100 in silodosin group and 100 in placebo group. Males using other contraceptive methods will be excluded. Follow up data of total spermatozoa per ejaculate, semen volume and Post-ejaculation urinalysis after 2, 6 and 12 weeks of the studied groups will be recorded. The various side effects reported in the study groups after 12 weeks from the start of the study will be recorded.

Enrollment: 200 estimated patients

Sex: Male

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male sexually active

Exclusion criteria

• male on oral contraceptives Male with female partner on contraceptives

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups, including a placebo group

Sildosin arm

Active Comparator group

Description:

Oral intake of sildosin

Treatment:

Drug: Oral intake of sildosin

Placebo arm

Placebo Comparator group

Description:

Oral intake of placebo

Treatment:

Other: Oral intake of placebo