NCT07195097

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2025

Shorter than P25 for phase_1

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

September 26, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

July 14, 2025

Last Update Submit

September 25, 2025

Conditions

Contraception Use

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rate in people treated with sildosin as a male contraceptive

    Pregnancy rate in people treated with sildosin as a male contraceptive treatment

    3 months

Study Arms (2)

Sildosin arm

ACTIVE COMPARATOR

Oral intake of sildosin

Drug: Oral intake of sildosin

Placebo arm

PLACEBO COMPARATOR

Oral intake of placebo

Other: Oral intake of placebo

Interventions

Oral intake of sildosinDRUG

Oral intake of sildosin in male non hormonal contraception

Sildosin arm
Oral intake of placeboOTHER

Intake of placebo to compare effecacy of other group

Placebo arm

Eligibility Criteria

Age20 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male sexually active

You may not qualify if:

  • male on oral contraceptives Male with female partner on contraceptives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer and consultant of urology

Study Record Dates

First Submitted

July 14, 2025

First Posted

September 26, 2025

Study Start

September 1, 2025

Primary Completion

November 1, 2025

Study Completion

December 1, 2025

Last Updated

September 26, 2025

Record last verified: 2025-09