Evaluation of Tolerance and Acceptability of a Coated Condom

NCT01619397 | Completed

• 1 other identifier: NPD 684_03
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tolerance and Acceptability of a New Condom Coating

Keywords

Condom; Medical Device

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  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.

  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).

Study Arms (1)

Condom

OTHER

Test condom with new Xanthan gum condom coating

Device: Test condom with new Xanthan gum condom coating

Interventions

Test condom with new Xanthan gum condom coating DEVICE

Condom

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Reckitt Benckiser LLC: lead

Study Sites (1)

Alba Science Ltd, 24 Brought Street

Edinburgh, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2012
• First Posted: June 14, 2012
• Study Start: September 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: November 1, 2012
• Last Updated: September 11, 2017

Record last verified: 2017-09

Locations

GB (1)