Randomised Controlled Trial of Condoms Plus Additional Lubrication

This study has been completed.
Sponsor:
Information provided by:
University of Manchester
ClinicalTrials.gov Identifier:
NCT00369213
First received: August 24, 2006
Last updated: NA
Last verified: December 2004
History: No changes posted
  Purpose

This RCT compares the clinical and non clinical condom failure rate among condom using heterosexual couples with and without externally applied additional spermicidal lubricant. The hypothesis is that breakage and slippage rates will be reduced.


Condition Intervention Phase
Contraception
Device: Additional spermicidal lubricant to condoms
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomised Controlled Trial of the Effect of Additional Spermicidal Lubrication on Condom Failure

Further study details as provided by University of Manchester:

Primary Outcome Measures:
  • Condom failure- breakage or slippage

Estimated Enrollment: 200
Study Start Date: April 1998
Estimated Study Completion Date: April 2002
Detailed Description:

A recent retrospective cohort study of 1006 subjects reported a marked reduction in condom failure amongst users applying additional lubrication. Improving the reliability of condoms would reduce the incidence of unwanted pregnancies and STI's (and hence health and social costs). This trial investigates the relative risk reduction amongst couples applying additional spermicidal lubrication to condoms, other factors associated with condom failure, the acceptability and side effects of additional spermicide and its cost effectiveness.

200 regular condom users will be recruited from family planning clinics and other community sources. A randomised, controlled investigator blinded, crossover design is being used. Participants will be reviewed at 3 and 6 months. Couples will be randomised to start either with latex condoms alone (Durex Extra Safe) or with additional Duragel (nonoxynol-9 contracceptive gel) applied to the outside of the condom prior to initial penetration. Participants are heterosexual couples using condoms for vaginal non-commercial intercourse in stable relationships of at least 3 months duration. Those under 18, or unable to provide data due to communication difficulties will be excluded from the trial.

Data will be collected by questionnaires for all subjects on their contraceptive and STI history, key demographic, social and behavioural factors relevant to condom failure risk at baseline. At crossover and trial end the rate and types of condom failure, side effects and acceptability of additional spermicide, and health service and subject costs are collected. A random sample of subjects also participate in a detailed semi-structured interview at the end of the study, covering their recent experiences of condom failure, and opinions about condoms in general, including the use of additional spermicide. These qualitative findings will then be discussed in patient and professional focus groups as a proxy for respondent checking and data triangulation.

The research will provide valuable, detailed information on factors associated with condom failure. Confirmation of the previous finding of the protective effects of additional spermicide would have a potentially major international impact in the fields of family planning and infectious diseases.

  Eligibility

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

Inclusion Criteria:

  • Condom using heterosexual couples in stable relationships

Exclusion Criteria:

  • Allergy to latex and or nonoxynol-9, communication difficulties precluding data collection
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00369213

Sponsors and Collaborators
University of Manchester
Investigators
Principal Investigator: Mark B Gabbay, MBChG MD University of Liverpool
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00369213     History of Changes
Other Study ID Numbers: RDO/18/67
Study First Received: August 24, 2006
Last Updated: August 24, 2006
Health Authority: United Kingdom: Department of Health

Keywords provided by University of Manchester:
Crossover trial
condom failure
additional spermicidal lubricant

ClinicalTrials.gov processed this record on October 19, 2014