ContraceptionPhase 4NCT00369213
Randomised Controlled Trial of Condoms Plus Additional Lubrication
A Phase 4 study testing Additional spermicidal lubricant to condoms in people with Contraception, run by University of Manchester.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Additional spermicidal lubricant to condoms
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Apr 1998to Apr 2002
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Condom using heterosexual couples in stable relationships
Who cannot join
- Allergy to latex and or nonoxynol-9, communication difficulties precluding data collection
About this study
Official title: Randomised Controlled Trial of the Effect of Additional Spermicidal Lubrication on Condom Failure
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.
Read the 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.
- Conditions
- Contraception
- Being tested
- Additional spermicidal lubricant to condoms
- Keywords
- Crossover trial, condom failure, additional spermicidal lubricant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional spermicidal lubricant to condomsDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Condom failure- breakage or slippage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startApr 1998
- Study completionApr 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Investigators
- Mark B Gabbay, MBChG MD, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369213
- Sponsor's protocol ID
- RDO/18/67
- Status last verified
- Dec 2004
- First submitted
- 24 Aug 2006
- Last updated
- 29 Aug 2006
- Results posted
- No
Publications
Gabbay M, Thomas J. When free condoms and spermicide are not enough: barriers and solutions to participant recruitment to community-based trials. Control Clin Trials. 2004 Aug;25(4):388-99. doi: 10.1016/j.cct.2004.06.004.
PubMed 15296813Gabbay MB, Thomas J, Gibbs A, Hold P. A randomized crossover trial of the impact of additional spermicide on condom failure rates. Sex Transm Dis. 2008 Oct;35(10):862-8. doi: 10.1097/OLQ.0b013e31817fb802.
PubMed 18685543
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of the Effect of Additional Spermicidal Lubrication on Condom Failure
- ClinicalTrials.gov ID
- NCT00369213
- Acronym / sponsor ID
- RDO/18/67
- Conditions
- Contraception
- Keywords
- Crossover trial, condom failure, additional spermicidal lubricant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- Apr 1998
- Study completion
- Apr 2002
- First posted
- 29 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Condom using heterosexual couples in stable relationships
Key exclusion criteria (1 listed)
- Allergy to latex and or nonoxynol-9, communication difficulties precluding data collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional spermicidal lubricant to condoms | Device | – |
Primary outcome
Condom failure- breakage or slippage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2006.
- Background: PubMed 15296813Gabbay M, Thomas J. When free condoms and spermicide are not enough: barriers and solutions to participant recruitment to community-based trials. Control Clin Trials. 2004 Aug;25(4):388-99. doi: 10.1016/j.cct.2004.06.004.
- Derived from this study: PubMed 18685543Gabbay MB, Thomas J, Gibbs A, Hold P. A randomized crossover trial of the impact of additional spermicide on condom failure rates. Sex Transm Dis. 2008 Oct;35(10):862-8. doi: 10.1097/OLQ.0b013e31817fb802.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark B Gabbay, MBChG MD principal investigator
University of Liverpool
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Additional spermicidal lubricant to condoms in people with Contraception, run by University of Manchester.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Condom failure- breakage or slippage. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00369213, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2006.