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Sawant Sangeeta
Miranda Cowen, Gabriel Conder, Nicola Kaganson, Andrew Nunn, Sheena Mccormack, Charles Lacey,, Wadi Gedroyc
MRC/DFID Microbicide development programme (MDP)
Background
Phase 1/2 studies have confirmed the safety and acceptability of Dextrin Sulphate (DS) as a vaginal microbicide. To provide effective protection against sexually transmitted diseases, DS should maximally cover the cervix and vagina before and after sex. Magnetic resonance imaging (MRI) can be used to monitor the intravaginal distribution of microbicide gels. In this study we will determine whether sexual intercourse affects the distribution and retention of the gel over 24 hours.
Methods
The study has been approved by the local research ethics committee. It will be an open label prospective single centre trial with 6 subjects. Subjects will be scanned twice over two 24 hour periods, once having sexual intercourse following gel application and once abstaining from intercourse. DS will be mixed with gadolinium chelate and introduced intravaginally by the female volunteers using a conventional applicator. MRI assessments will be made prior to, and immediately after gel application and 12 hours and 24 hours after gel administration. Study end points will include signal intensity readings for gel at predetermined sites within the vagina, assessment of the degree of cervico-vaginal mucosa covered by gel and visual assessment of the uniformity and distribution of gel within the genital tract.
Results
Women will act as their own controls to enable us to estimate the effect of intercourse on the retention and distribution of gel over 24 hours. The data obtained from the assessment will be analysed using a paired student T test and 95% confidence intervals.
Discussion
Although there has been one previous report of N9 distribution after coitus, we will use MRI signal intensity readings to analyse the distribution and retention of DS following intercourse over a 24 hour period.
Dr Sangeeta Sawant
Clinical Trials Centre, Winston Churchill Wing, St Marys hospital Campus, Imperial College London, Norfolk place, London W2 1PG
(Telephone) 020 7886 6738 (Fax) 020 7886 6123 (E-mail) ssawant@imperial.ac.uk
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