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Randomised Controlled Trial of Condoms Plus Additional Lubrication

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00369213
First Posted: August 29, 2006
Last Update Posted: August 29, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Manchester
  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
Intervention Model: Crossover Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00369213


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

Publications:
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
First Submitted: August 24, 2006
First Posted: August 29, 2006
Last Update Posted: August 29, 2006
Last Verified: December 2004

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