Sildosin as a Male Contraceptive Non Hormonal

NCT ID: NCT07195097

Last Updated: 2025-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Contraception Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Sildosin arm

Oral intake of sildosin

Group Type ACTIVE_COMPARATOR

Oral intake of sildosin

Intervention Type DRUG

Oral intake of sildosin in male non hormonal contraception

Placebo arm

Oral intake of placebo

Group Type PLACEBO_COMPARATOR

Oral intake of placebo

Intervention Type OTHER

Intake of placebo to compare effecacy of other group

Interventions

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Oral intake of sildosin

Oral intake of sildosin in male non hormonal contraception

Intervention Type DRUG

Oral intake of placebo

Intake of placebo to compare effecacy of other group

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* male sexually active

Exclusion Criteria

* male on oral contraceptives Male with female partner on contraceptives
Minimum Eligible Age

20 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Mohamed Farag Ali

Lecturer and consultant of urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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RC 5-10-2024

Identifier Type: -

Identifier Source: org_study_id

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