Contraception UsePhase 1NCT07195097
Sildosin as a Male Contraceptive Non Hormonal
A Phase 1 study testing Oral intake of sildosin in people with Contraception Use, run by Benha University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Contraception Use
- What is being tested?
- Oral intake of sildosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male sexually active
Who cannot join
- male on oral contraceptives Male with female partner on contraceptives
About this study
Official title: A Prospective Study to Evaluate the Efficacy of Silodosin 8 mg as an on-Demand, Reversible, Nonhormonal Oral Contraceptive for Males:
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.
- Conditions
- Contraception Use
- Being tested
- Oral intake of sildosin, Oral intake of placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral intake of sildosinDrug
Oral intake of sildosin in male non hormonal contraception
Oral intake of placeboOther
Intake of placebo to compare effecacy of other group
| Study group | Role | What they receive |
|---|---|---|
| Sildosin arm | Active comparator | Oral intake of sildosin Receives: Drug: Oral intake of sildosin |
| Placebo arm | Placebo comparator | Oral intake of placebo Receives: Other: Oral intake of placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate in people treated with sildosin as a male contraceptive
Pregnancy rate in people treated with sildosin as a male contraceptive treatment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraception UseStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Mohamed Farag Ali, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195097
- Sponsor's protocol ID
- RC 5-10-2024
- Status last verified
- Sep 2025
- First submitted
- 14 Jul 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Efficacy of Silodosin 8 mg as an on-Demand, Reversible, Nonhormonal Oral Contraceptive for Males:
- ClinicalTrials.gov ID
- NCT07195097
- Acronym / sponsor ID
- RC 5-10-2024
- Conditions
- Contraception Use
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sildosin arm | Active comparator | Drug: Oral intake of sildosinOral intake of sildosin |
| Placebo arm | Placebo comparator | Other: Oral intake of placeboOral intake of placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- male sexually active
Key exclusion criteria (1 listed)
- male on oral contraceptives Male with female partner on contraceptives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral intake of sildosinOral intake of sildosin in male non hormonal contraception | Drug | Sildosin arm |
| Oral intake of placeboIntake of placebo to compare effecacy of other group | Other | Placebo arm |
Primary outcome
Pregnancy rate in people treated with sildosin as a male contraceptive
Time frame: 3 months
Pregnancy rate in people treated with sildosin as a male contraceptive treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oral intake of sildosin in people with Contraception Use, run by Benha University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy rate in people treated with sildosin as a male contraceptive (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.