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Not yet recruiting NCT07195097

Sildosin as a Male Contraceptive Non Hormonal

Phase I Interventional Contraception Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oral intake of sildosin, Oral intake of placebo.
Who it may be relevant to
Registry conditions: Contraception Use. Basic parameters: from 20 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Prospective Study to Evaluate the Efficacy of Silodosin 8 mg as an on-Demand, Reversible, Nonhormonal Oral Contraceptive for Males:

Overview

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.

Interventions

  • Drug Oral intake of sildosin
    Oral intake of sildosin in male non hormonal contraception
  • Other Oral intake of placebo
    Intake of placebo to compare effecacy of other group

Primary outcome measures

  • Pregnancy rate in people treated with sildosin as a male contraceptive [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • male sexually active

Exclusion criteria

  • male on oral contraceptives Male with female partner on contraceptives

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07195097 · RC 5-10-2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗