Status:
COMPLETED
A Pilot Functional Performances Study of Two Synthetic Male Condom
Lead Sponsor:
Clinical Research Centre, Malaysia
Collaborating Sponsors:
Twin Catalyst Sdn. Bhd.
Sarawak Research Society
Conditions:
Functional Performance
Synthetic Male Condom
Eligibility:
MALE
18-45 years
Phase:
NA
Brief Summary
Over the decades, male condoms had been widely commercialized and used to protect against unintended pregnancy and sexually transmitted infections (STI). While natural rubber latex (NRL) male condoms ...
Eligibility Criteria
Inclusion
- Their female sexual partners are not at risk of pregnancy (using alternate contraception);
- They don't have known sexually transmitted infections, including HIV/AIDS;
- They should be experienced condom users, minimum 10 male condoms used in the last 12 months;
- They are between 18 to 45 years of age;
- They are in a monogamous heterosexual relationship and agree to practice vaginal sex only using male condoms provided by the study.
Exclusion
- couples who work for the research team or who are close relatives of the research team;
- men with known allergy to natural rubber latex;
- men with known sensitivity to the residual chemicals used in the manufacture of natural rubber latex condoms or the test condom materials;
- couples where one knowingly has a sexually transmitted infection.
- couples who are pregnant in time of recruitment
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03324594
Start Date
November 1 2017
End Date
March 31 2018
Last Update
July 18 2018
Active Locations (2)
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1
Sarawak Family Planning Association
Kuching, Sarawak, Malaysia, 93400
2
Sarawak Research Society
Kuching, Sarawak, Malaysia, 94200