Condition category
Infections and Infestations
Date applied
22/07/2009
Date assigned
07/09/2009
Last edited
16/05/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

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

http://www.york.ac.uk/

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

Publication citations

Additional files

Editorial Notes