None listed
Conditions
Brief summary
This project aims to obtain the views of people about what they think about the Geldom and how it performs (e.g. did it break or slip) compared with a latex condom during intercourse. It is not testing the condom’s performance as a barrier contraceptive or at how it prevents STI transmission. The information will be used to support the development of additional studies that will look at confirming the views and performance of the Geldom during intercourse, these studies are called pivotal studies. The study requires that you are sexually active and in a stable current relationship of equal or greater than 3 months. You will be required to have penile-vaginal intercourse with your partner a total of 6 times over a 4 week period while using the condom provided by the study; either the Geldom condom or a latex condom.
Interventions
Hydrogel Male Condom (Geldom)
This study is an open label, two-way crossover study, randomised to sequence of use, designed to describe the preference, and acceptability and performance of an investigational experimental male condom (Geldom) compared to a commercial latex male condom.
This study will evaluate user experience and evaluate the performance of the Geldom through comparison with a commercial latex competitor condom, describe some initial preference measures, clinical slippage and br
Hydrogel Male Condom (Geldom) This study is an open label, two-way crossover study, randomised to sequence of use, designed to describe the preference, and acceptability and performance of an investigational experimental male condom (Geldom) compared to a commercial latex male condom. This study will evaluate user experience and evaluate the performance of the Geldom through comparison with a commercial latex competitor condom, describe some initial preference measures, clinical slippage and breakage rates and user acceptability. These data inform baseline measures and effect size used for the design of the future regulatory studies for registration. The sample will be drawn from healthy young to middle aged (18-45 years) heterosexual, mutually monogamous couples and sample size of 35 couples. To minimise a potential learning effect, couples will be randomly assigned to the sequence of use of condom type (Geldom condom then commercial latex condom or commercial latex condom then Geldom condom). The participants will use 3 Geldom condoms and 3 latex condoms over an estimated 4 week period. Participants will use all 3 of one type of condom before crossing over to the next condom. At their enrollment visit participants will receive three condoms of the first type of study condom based on their randomisation group and study lubricant (silicone and water based). Participants will take the condoms home for use in their own environment and scheduled for their visit 2 in 14 days (+/- 2 days). At visit 2 they will receive a supply of 3 condoms of the second type of condom according to their randomisation, additional study lubricant and will be scheduled for their exit visit within two weeks. Participants are required to complete the following activities as part of this study: 1. Have penile-vaginal intercourse 6 times while using either the Geldom or commercial latex condom 2. Return any open and unopened condom packets 3. Measure flaccid and erect penis (males only) 4. Complete questionnaires on the experience of the condoms used after each use and less than 12 hours after intercourse. Couples will be taught the correct way to use the study condoms and provided instructions for use and how to dispose of used condoms. There are no restrictions on the time that must elapse between use of the condoms. There is no 'wash-out' period required for cross-over between the different types of condoms other than that of the time between the last condom used from visit 1 and using the first condom provided at visit 2, Adherence to use is monitored via the tracking of returned opened and unopened packets against the Investigational Product tracking log.
Sponsors
Eudaemon technologies PTY LTD
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
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
Exclusion criteria
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)
Outcome results
None listed