A evaluation of the preference, performance and acceptability of an investigational hydrogel male condom (Geldom) compared to a commercial latex condom during vaginal intercourse.
- Conditions
- nintended pregnancySexually Transmitted Infections (STIs)Unintended pregnancyReproductive Health and Childbirth - ContraceptionInfection - Sexually transmitted infections
- Registration Number
- ACTRN12624000066583
- Lead Sponsor
- Eudaemon technologies PTY LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 70
Mutually monogamous, heterosexual, current relationship greater than or equal to 3 months
Aged between 18 – 45 years (inclusive)
Sexually active, sufficient to meet protocol requirements
Agree to have penile-vaginal intercourse with frequency sufficient to meet protocol requirements and at either participants given home address in a standard environment for sexual intercourse (e.g. bedroom)
Have used 6 condoms in their lifetime, including at least 1 latex condom
Allergic or sensitive to the material(s) of the test or control condom;
Female partner self-reported as pregnant or desires to become pregnant while participating in the study
Male partner has had difficulty achieving or maintaining an erection, or achieving ejaculation in the last month under typical circumstances/conditions
Known allergy or sensitivity to personal lubricants, including water based or silicone lubricants
A known sexually transmitted infections including HIV/AIDS or risk of sexually transmitted infections, including HIV infection, or having a medical history of untreated and/or recurrent, serious sexually transmitted infection (e.g. Gonorrhoea, Syphilis, Chlamydia, herpes)
History of sexual anxiety and/or pain during sex;
Has any penile abnormalities (e.g. Peyronie’s disease, hypospadias, intersex, phimosis, penile cancer, micro-penis, previous penile or prostatic surgery)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method