Randomised controlled trial of condoms plus additional lubrication
| ISRCTN | ISRCTN59655786 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59655786 |
| Protocol serial number | RHC18067 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive North West (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 08/09/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mark Gabbay
Scientific
Scientific
University of Liverpool
Dept of Primary Care
Whelan Building
Quadrangle
Brownlow Hill
Liverpool
L69 3GB
United Kingdom
| Phone | +44 0151 794 5597/5614 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled crossover trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Does the application of additional spermicidal lubrication to condoms reduce the risk of condom failure amongst couples? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Contraception |
| Intervention | 1. Use of condoms only 2. Use of condoms with additional spermicide |
| Intervention type | Other |
| Primary outcome measure(s) |
Condom failure |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/07/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 290 |
| Key inclusion criteria | Couples over the age of 18 years and intend to use condoms regularly and who do not use additional lubricant with them. |
| Key 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 |
| Date of first enrolment | 01/10/1997 |
| Date of final enrolment | 01/07/2001 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University of Liverpool
Liverpool
L69 3GB
United Kingdom
L69 3GB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2008 | Yes | No |
