Evaluation of Tolerance and Acceptability of a Coated Condom

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser LLC
ClinicalTrials.gov Identifier:
NCT01619397
First received: June 1, 2012
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Tolerance and Acceptability of a New Condom Coating
Device: Xanthan gum coating on a standard natural rubber latex (NRL) condom

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Clinical Investigation Report for the Clinical Investigation to Evaluate In-use Genital Tolerance and User Acceptability of a Xanthan Gum Coating on a Standard Natural Rubber Latex (NRL) Condom in Healthy Volunteer Mutually Monogamous Adult Couples

Resource links provided by NLM:


Further study details as provided by Reckitt Benckiser LLC:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    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.

  • 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). ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 50
Study Start Date: September 2012
Study Completion Date: November 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Condom
This Investigation was designed to be conducted with 50 healthy heterosexual volunteer couples to confirm in use tolerance and acceptability of a new Xanthan gum condom coating and as such did not confer any clinical benefit to the users.
Device: Xanthan gum coating on a standard natural rubber latex (NRL) condom

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion

  • 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.

Exclusion

  • 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.
  • 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01619397

Locations
United Kingdom
Alba Science Ltd, 24 Brought Street
Edinburgh, United Kingdom
Sponsors and Collaborators
Reckitt Benckiser LLC
  More Information

No publications provided

Responsible Party: Reckitt Benckiser LLC
ClinicalTrials.gov Identifier: NCT01619397     History of Changes
Other Study ID Numbers: NPD 684_03
Study First Received: June 1, 2012
Last Updated: September 12, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Reckitt Benckiser LLC:
Condom
Medical Device

ClinicalTrials.gov processed this record on August 26, 2014