Tolerance and Acceptability of a New Condom CoatingNCT01619397
Evaluation of Tolerance and Acceptability of a Coated Condom
A study testing Test condom with new Xanthan gum condom coating in people with Tolerance and Acceptability of a New Condom Coating, run by Reckitt Benckiser LLC at 1 site in United Kingdom.
Trial summary
This Clinical Investigation is designed to provide tolerance, acceptability and safety data of a new condom coating, in its intended use to support future application for CE Mark. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tolerance and Acceptability of a New Condom Coating
- What is being tested?
- Test condom with new Xanthan gum condom coating
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2012to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy sexually active mutually monogamous heterosexual couples.
- Subjects at least 18 years of age
- Subjects who are willing and able to take part, attend all required visits, able to understand the information given to them and give written consent
- Couples who are be experienced latex condom users as defined by repeated use without significant problems.
- Couples must agree to use the condoms provided plus be using one other acceptable form of non barrier contraception (i.e. sterilisation/vasectomy, intra-uterine device (IUD) or intra-uterine system (IUS), hormonal contraception) unless female partner is post-menopausal (i.e. over 50 and, prior to screening, amenorrhea for at least 12 months after cessation of exogenous hormone treatment) in which case no second form of contraception is required.
- No signs of abnormalities in the medical history that the investigator would consider as clinically relevant.
- No clinically relevant findings in physical assessments
- Subject not aware of any reason why they will not be able to engage in 1 act of vaginal intercourse per Condon Use Period.
Who cannot join
- Presence or history of allergy or sensitivity to topical vaginal products Latex, Xanthan Gum or any other Investigation products
- Pre-existing skin or systemic allergic reaction or severe eczema
- Previous history of frequent problems associated with the use of condoms
- Currently active or a history of recurrent STI's including HIV infection in one or either partner.
- Participation in a clinical trial in the previous month which could, in the opinion of the investigator, affect the outcome of the Investigation.
- Intentions to continue use of concurrent vaginal lubricants or treatments for the duration of the Investigation.
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- Either partner with genital piercing
- Female partners who are pregnant or breast feeding
- Female partners seeking to become pregnant in the duration of the Investigation
- Female partner who has been diagnosed with or treated for a vaginal complaint in the previous 3 months which in the Investigators opinion indicated the partner is unsuitable for the Investigation
- Female partner suffering from known vaginal dryness
- Female partner using medication which would affect vaginal mucosal secretion, such as Chlorpheniramine.
- Male partners using medication that would affect ability to obtain and maintain an erection through to normal ejaculation
- Male partners with abnormal penile anatomy that would affect ability to keep condom in place during intercourse
- Males partner with diagnosis of penile skin condition within previous 3 months (e.g. conditions associated with balanoposthitis: penile psoriasis; lichen sclerosis; eczema) as confirmed by subject and by genital examination.
- Intentions to continue to use antihistamines, anti inflammatory drugs, or pain killers for the duration of the Investigation
- Suffering from any condition which could, in the opinion of the Investigator, affect the outcome of the Investigation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Investigation to Evaluate In-use Genital Tolerance and User Acceptability of a Xanthan Gum Coating on a Standard Natural Rubber Latex Condom in Healthy Volunteer Mutually Monogamous Adult Couples
This Clinical Investigation is designed to provide tolerance, acceptability and safety data of a new condom coating, in its intended use to support future application for CE Mark.
Read the detailed description
The Investigational Device is a standard Natural Rubber Latex (NRL) condom with a coating on the inside and outside. The Investigational Device is dry to the touch on removal from the foil. When the coated condom comes into contact with body fluids upon penetration it absorbs the moisture and forms a lubricious (slippery) layer on the condom. From this point, the coating and the standard NRL condom feel and behave like a standard pre lubricated condom.
Condoms are a widely used, cheap and effective contraceptive and an important primary prevention strategy that can substantially reduce the likelihood of transmitting sexually transmitted infections (STI's) (Holmes et al, 2004). Consumer studies have revealed that the 'messiness' associated with pre lubricated condoms can be off putting to the consumer and possibly deter use completely. It is thought that as the condom coating is initially dry to the touch this may remove the 'messiness'.
The duration of the Investigation is 3 days. In that time subjects will attend the clinic 3 times, (Day 1, Day 2 and Day 3) for baseline assessments and subsequent Clinical Assessments. Clinical Assessments will include an examination of the external genitals (both male and female subjects) and internal genitals (female subjects only) in order to make an assessment of dermal tolerance of the area when exposed to a Project Unusual Condom in-use.
Couples will be provided with Investigation Device at visit 1 and Visit 2. There is a 24 hour period after receipt of Investigational Device in which couples are asked to use the condom for 1 act of vaginal intercourse, recording compliance and their experience of the Investigational Device in a Diary Card and questionnaire.
Assessments of tolerance will be made by the PI throughout the Investigation. The PI is a Physician with extensive Dermatology training. Assessments of dermal tolerance will include scoring particular sites according to a Total Irritancy score, providing a Global Assessment of Tolerance and at the end of the Clinical Investigation the Investigator will make an Overall Tolerance Rating Statement.
- Being tested
- Test condom with new Xanthan gum condom coating
- Keywords
- Condom, Medical Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test condom with new Xanthan gum condom coatingDevice
| Study group | Role | What they receive |
|---|---|---|
| Condom | Other | Test condom with new Xanthan gum condom coating Receives: Device: Test condom with new Xanthan gum condom coating |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate dermatological tolerance.
To determine the in-use genital tolerance of Xanthan gum coating on a standard natural rubber latex (NRL) condom, as a lubricant for vaginal intercourse
Measured: The active phase of this Investigation lasted less than 1 week per participating couple and within this period there were a total of 3 visits (Day 1, Day 2 and Day 3).
Secondary outcomes (2)
User acceptability.
To assess user acceptability of Xanthan gum coating on standard NRL condom as defined by 70% of subjects selecting the top two boxes in applicable questions of acceptability questionnaire.
Measured: The active phase of this Investigation lasted less than 1 week per participating couple and within this period there were a total of 3 visits (Day 1, Day 2 and Day 3).
Assessment of safety profile.
To determine in-use safety of Xanthan gum coating on standard NRL condom in terms of frequency and severity of device deficiencies, malfunction, or adverse device effect.
Measured: The active phase of this Investigation lasted less than 1 week per participating couple and within this period there were a total of 3 visits (Day 1, Day 2 and Day 3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tolerance and Acceptability of a New Condom CoatingStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reckitt Benckiser LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619397
- Sponsor's protocol ID
- NPD 684_03
- Status last verified
- Sep 2017
- First submitted
- 1 Jun 2012
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation to Evaluate In-use Genital Tolerance and User Acceptability of a Xanthan Gum Coating on a Standard Natural Rubber Latex Condom in Healthy Volunteer Mutually Monogamous Adult Couples
- ClinicalTrials.gov ID
- NCT01619397
- Acronym / sponsor ID
- NPD 684_03
- Keywords
- Condom, Medical Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Reckitt Benckiser LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 14 Jun 2012 (estimated)
- 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.
This Clinical Investigation is designed to provide tolerance, acceptability and safety data of a new condom coating, in its intended use to support future application for CE Mark.
Detailed description
The Investigational Device is a standard Natural Rubber Latex (NRL) condom with a coating on the inside and outside. The Investigational Device is dry to the touch on removal from the foil. When the coated condom comes into contact with body fluids upon penetration it absorbs the moisture and forms a lubricious (slippery) layer on the condom. From this point, the coating and the standard NRL condom feel and behave like a standard pre lubricated condom.
Condoms are a widely used, cheap and effective contraceptive and an important primary prevention strategy that can substantially reduce the likelihood of transmitting sexually transmitted infections (STI's) (Holmes et al, 2004). Consumer studies have revealed that the 'messiness' associated with pre lubricated condoms can be off putting to the consumer and possibly deter use completely. It is thought that as the condom coating is initially dry to the touch this may remove the 'messiness'.
The duration of the Investigation is 3 days. In that time subjects will attend the clinic 3 times, (Day 1, Day 2 and Day 3) for baseline assessments and subsequent Clinical Assessments. Clinical Assessments will include an examination of the external genitals (both male and female subjects) and internal genitals (female subjects only) in order to make an assessment of dermal tolerance of the area when exposed to a Project Unusual Condom in-use.
Couples will be provided with Investigation Device at visit 1 and Visit 2. There is a 24 hour period after receipt of Investigational Device in which couples are asked to use the condom for 1 act of vaginal intercourse, recording compliance and their experience of the Investigational Device in a Diary Card and questionnaire.
Assessments of tolerance will be made by the PI throughout the Investigation. The PI is a Physician with extensive Dermatology training. Assessments of dermal tolerance will include scoring particular sites according to a Total Irritancy score, providing a Global Assessment of Tolerance and at the end of the Clinical Investigation the Investigator will make an Overall Tolerance Rating Statement.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Condom | Other | Device: Test condom with new Xanthan gum condom coatingTest condom with new Xanthan gum condom coating |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy sexually active mutually monogamous heterosexual couples.
- Subjects at least 18 years of age
- Subjects who are willing and able to take part, attend all required visits, able to understand the information given to them and give written consent
- Couples who are be experienced latex condom users as defined by repeated use without significant problems.
- Couples must agree to use the condoms provided plus be using one other acceptable form of non barrier contraception (i.e. sterilisation/vasectomy, intra-uterine device (IUD) or intra-uterine system (IUS), hormonal contraception) unless female partner is post-menopausal (i.e. over 50 and, prior to screening, amenorrhea for at least 12 months after cessation of exogenous hormone treatment) in which case no second form of contraception is required.
Key exclusion criteria (17 listed)
- Presence or history of allergy or sensitivity to topical vaginal products Latex, Xanthan Gum or any other Investigation products
- Pre-existing skin or systemic allergic reaction or severe eczema
- Previous history of frequent problems associated with the use of condoms
- Currently active or a history of recurrent STI's including HIV infection in one or either partner.
- Participation in a clinical trial in the previous month which could, in the opinion of the investigator, affect the outcome of the Investigation.
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 |
|---|---|---|
| Test condom with new Xanthan gum condom coating | Device | Condom |
Primary outcome
To demonstrate dermatological tolerance.
Time frame: The active phase of this Investigation lasted less than 1 week per participating couple and within this period there were a total of 3 visits (Day 1, Day 2 and Day 3).
To determine the in-use genital tolerance of Xanthan gum coating on a standard natural rubber latex (NRL) condom, as a lubricant for vaginal intercourse
2 secondary outcomes
User acceptability.
Time frame: The active phase of this Investigation lasted less than 1 week per participating couple and within this period there were a total of 3 visits (Day 1, Day 2 and Day 3).
Assessment of safety profile.
Time frame: The active phase of this Investigation lasted less than 1 week per participating couple and within this period there were a total of 3 visits (Day 1, Day 2 and Day 3).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test condom with new Xanthan gum condom coating in people with Tolerance and Acceptability of a New Condom Coating, run by Reckitt Benckiser LLC at 1 site in United Kingdom.
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 8 inclusion and 17 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: finished, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To demonstrate dermatological tolerance. (time frame: The active phase of this Investigation lasted less than 1 week per participating couple and within this period there were a total of 3 visits (Day 1, Day 2 and Day 3).). 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 11 Sep 2017.