Condition category
Pregnancy and Childbirth
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
08/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mark Gabbay

ORCID ID

Contact details

University of Liverpool
Dept of Primary Care
Whelan Building
Quadrangle
Brownlow Hill
Liverpool
L69 3GB
United Kingdom
+44 0151 794 5597/5614

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RHC18067

Study information

Scientific title

Acronym

Study hypothesis

Does the application of additional spermicidal lubrication to condoms reduce the risk of condom failure amongst couples?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled crossover trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Contraception

Intervention

1. Use of condoms only
2. Use of condoms with additional spermicide

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Condom failure

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/1997

Overall trial end date

01/07/2001

Reason abandoned

Eligibility

Participant inclusion criteria

Couples over the age of 18 years and intend to use condoms regularly and who do not use additional lubricant with them.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

145 couples

Participant exclusion criteria

1. Subjects who are not willing to be randomised or to use additional lubricant with their condoms
2. Subjects unlikely to allow follow-up or co-operate with outcome data collection
3. Subjects without a regular partner
4. Couples with a known sensitivity to spermicides or latex
5. Couples who are not intending to use condoms at least predominantly for vaginal intercourse

Recruitment start date

01/10/1997

Recruitment end date

01/07/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Liverpool
Liverpool
L69 3GB
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive North West (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18685543

Publication citations

  1. Results

    Gabbay 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, 35, 10, 862-868, doi: 10.1097/OLQ.0b013e31817fb802.

Additional files

Editorial Notes