Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000066583
Ethics application status
Approved
Date submitted
19/12/2023
Date registered
25/01/2024
Date last updated
25/01/2024
Date data sharing statement initially provided
25/01/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
A evaluation of the preference, performance and acceptability of an investigational hydrogel male condom (Geldom) compared to a commercial latex condom during vaginal intercourse.
Scientific title
A randomised open label two-way crossover evaluation of the preference, performance and acceptability of an investigational hydrogel male condom (Geldom) compared to a commercial latex condom during vaginal intercourse.
Secondary ID [1] 311020 0
None
Universal Trial Number (UTN)
Trial acronym
GEL-003
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unintended pregnancy 332421 0
Sexually Transmitted Infections (STIs) 332566 0
Condition category
Condition code
Reproductive Health and Childbirth 329113 329113 0 0
Contraception
Infection 329265 329265 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 327677 0
Treatment: Devices
Comparator / control treatment
Commercial Latex Condom which is provided to the participants
Control group
Active

Outcomes
Primary outcome [1] 336930 0
Total clinical failure rates for the test and control condom (commercial latex)
Timepoint [1] 336930 0
Day 14 and Day 28
Primary outcome [2] 336931 0
User acceptability
Timepoint [2] 336931 0
Day 14 and Day 28
Primary outcome [3] 337087 0
User preference
Timepoint [3] 337087 0
Day 28
Secondary outcome [1] 430193 0
Clinical slippage rates
Timepoint [1] 430193 0
Day 14 and Day 28

Eligibility
Key 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
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple - Odd and Even allocation
Odd participant id numbers will be assigned Geldom first then cross over to latex condom
Even participant id numbers will be assigned latex condom first then cross over to Geldom condom
Couples are assigned the same id number and distinguished by their suffix of M for Male and F for Female. EG 001M and 001F is one couple, two participants.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
24/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 315282 0
Commercial sector/Industry
Name [1] 315282 0
Eudaemon technologies PTY LTD
Country [1] 315282 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Eudaemon technologies PTY LTD
Address
Level 26, 44 Market Street, Sydney, NSW, 2000
Country
Australia
Secondary sponsor category [1] 317549 0
None
Name [1] 317549 0
Address [1] 317549 0
Country [1] 317549 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314204 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 314204 0
123 Glen Osmond Road, Eastwood, SA, 5063
Ethics committee country [1] 314204 0
Australia
Date submitted for ethics approval [1] 314204 0
25/08/2023
Approval date [1] 314204 0
19/10/2023
Ethics approval number [1] 314204 0
2023-08-1036

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130774 0
Dr Matthew Green
Address 130774 0
Cercare Pty Ltd 5 Greenhill Road, Wayville, SA 5034
Country 130774 0
Australia
Phone 130774 0
+61 0870953337
Fax 130774 0
Email 130774 0
[email protected]
Contact person for public queries
Name 130775 0
Nick Northcott
Address 130775 0
Eudaemon Technologies Pty Ltd Level 26, 44 Market Street, Sydney, NSW, 2000
Country 130775 0
Australia
Phone 130775 0
+61 0401071021
Fax 130775 0
Email 130775 0
[email protected]
Contact person for scientific queries
Name 130776 0
Simon Cook
Address 130776 0
Eudaemon Technologies Pty Ltd Level 26, 44 Market Street, Sydney, NSW, 2000
Country 130776 0
Australia
Phone 130776 0
+61 0401071021
Fax 130776 0
Email 130776 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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