Contact information
Type
Scientific
Primary contact
Prof Charles Lacey
ORCID ID
Contact details
Hull York Medical School (HYMS)
University of York
Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 725474
charles.Lacey@hyms.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 3
Study information
Scientific title
Magnetic resonance imaging study of the genital tract distribution and retention of microbicide 0.5% PRO 2000/5 Gel (P) in vivo: a partially blinded, randomised, two-arm, single-centre study
Acronym
MDP102/York 1:MRI
Study hypothesis
To assess and compare the distribution and retention of 0.5% PRO 2000/5 Gel (P), firstly over a 6-hour period and then before and after sexual intercourse; both using condoms and without using condoms.
Ethics approval
Cambridge 1 Research Ethics Committee on 30/01/2009 (ref: 08/H0304/99). The SSA (LREC York) also approved on the same date (ref: 08/H1311/115).
Study design
Partially blinded randomised two-arm single-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Can be found at http://www.yorkhivresearch.org.uk/
Condition
Sexually transmitted infection, human immunodeficiency virus (HIV) prevention
Intervention
All female participants will receive an intravaginal dose of 0.5% PRO 2000/5 Gel (P) mixed with gadolinium (Gd-PRO 2000/5 Gel [P]) and an MRI assessment at visit 2 (scans pre-application, immediate post-application, post-application plus two hours, post-application plus six hours), and at visits 3 and 4. At visit 3 participants are randomised 1:1 to differing arms:
Arm 1: participant will use a condom at visit 3, and then will not use a condom at visit 4
Arm 2: participant will not use a condom at visit 3, and use a condom at visit 4
MRI assessments for these two conditions at each of the visits will be conducted at two time-points:
1. Immediately post-application and pre-coitus
2. Post-coitus
Updated 16/05/2014: the trial was stopped on 31/03/2010.
Intervention type
Drug
Phase
Not Applicable
Drug names
PRO 2000/5 Gel (P), gadolinium
Primary outcome measures
Quantification of the amount of gel (signal intensity) at predetermined sites within the genital tract (lower vagina, mid vagina, cervix, posterior fornix, lateral fornix), at differing times after gel insertion, both pre and post-coitus.
Secondary outcome measures
1. Assessment of the length of cervico-vaginal mucosa covered by gel
2. Visual assessment of the uniformity and distribution of gel within the genital tract
Overall trial start date
01/10/2009
Overall trial end date
31/03/2010
Reason abandoned
Lack of staff/facilities/resources
Eligibility
Participant inclusion criteria
Female participants:
1. Aged 18 - 45 years. The upper age of 45 is felt to be important due to the need for female participants to have a regular menstrual cycle.
2. Sexually active with a current, stable, regular male partner
3. Not currently using condoms with this partner. This is important so that it is acceptable to randomise a participant to not using condoms.
4. Using hormonal contraception (except hormone-releasing intrauterine devices [IUDs])
5. Not known to be allergic to gadolinium
6. Willing and able to adhere to the study conditions and methodology
7. Willing and able to give written and signed informed consent to trial participation and procedures
8. Willing to use condoms in the context of the trial
9. Willing to have a human immunodeficiency virus (HIV) test (venous blood, HIV antibody test)
Male partners:
1. Aged 18 - 55 years. The upper age limit for men is felt to be appropriate to minimise age related conditions.
2. Independently reports that they are not currently using condoms with this partner
3. Not known to be allergic to gadolinium (as the male partner may come into contact with gadolinium during the act of unprotected coitus for study purposes)
4. Willing and able to adhere to the study conditions and methodology
5. Willing and able to give written informed consent to trial participation and procedures
6. Willing to use condoms in the context of the trial
7. Willing to have a HIV test (venous blood, HIV antibody test)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
10 healthy women and their healthy regular male partners (total = 20)
Participant exclusion criteria
Females only:
1. Pregnancy or lactation
2. Gynaecological instrumentation and procedures of the cervix/uterus in the last three months including cervical polypectomy, dilatation and curettage, endometrial biopsy, loop excision, etc.
3. Contraindication to MRI such as intracerebral aneurysm clip or implanted electronic devices
4. Currently participating in, or having participated in the last 3 months prior to the first screening visit, any other vaginal microbicide or mucosal vaccine study or clinical trial of an investigational agent
Females and males:
1. Untreated syphilis, gonorrhoea, trichomonas, chlamydia, candida or bacterial vaginosis
2. Current genital tract infection
3. HIV infection
4. Active hepatitis B or C infection
5. History of coagulation disorders
6. Significant haematological, biochemical, or coagulation assay abnormalities on screening
7. Unlikely to comply with protocol
Recruitment start date
01/10/2009
Recruitment end date
31/03/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Hull York Medical School (HYMS)
York
YO10 5DD
United Kingdom
Sponsor information
Organisation
University of York (UK)
Sponsor details
c/o Sue Final
Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 430000
smf3@york.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Department for International Development (DFID) (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