Evaluation of Tolerance and Acceptability of a Coated Condom
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.
Tolerance and Acceptability of a New Condom Coating
Device: Xanthan gum coating on a standard natural rubber latex (NRL) condom
|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|
- 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
- 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.
|Study Start Date:||September 2012|
|Study Completion Date:||November 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
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|
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.