Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof Charles Lacey
+44 (0)1904 725474
charles.Lacey@hyms.ac.uk


Study Location:

Hull York Medical School (HYMS)
York
YO10 5DD


Skip to Main Content

Magnetic Resonance Imaging (MRI) scan of the vagina to measure how well the microbicide 0.5% PRO 2000/5 Gel (P) spreads around and remains within the vagina

Stopped

Open to: All Genders

Age: Adult

Medical Conditions

Sexually transmitted infection, human immunodeficiency virus (HIV) prevention


Study summary

http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=17

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.


Partially blinded randomised two-arm single-centre trial

Key dates

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Oct 2009

31 Mar 2010

Study type

Interventional

Intervention Type : Drug
Intervention Name : PRO 2000/5 Gel (P), gadolinium
Intervention Description : 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 4Arm 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-coitus2. Post-coitus

Updated 16/05/2014: the trial was stopped on 31/03/2010.


Who can take part?

You can take part if:


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 partner3. 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 gadolinium6. Willing and able to adhere to the study conditions and methodology7. Willing and able to give written and signed informed consent to trial participation and procedures8. Willing to use condoms in the context of the trial9. 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 partner3. 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 methodology5. Willing and able to give written informed consent to trial participation and procedures6. Willing to use condoms in the context of the trial7. Willing to have a HIV test (venous blood, HIV antibody test)




You may not be able to take part if:

Females only:1. Pregnancy or lactation2. 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 devices4. 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 vaginosis2. Current genital tract infection3. HIV infection4. Active hepatitis B or C infection5. History of coagulation disorders6. Significant haematological, biochemical, or coagulation assay abnormalities on screening7. Unlikely to comply with protocol


Where can I take part?

Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Hull York Medical School (HYMS)
    York
    YO10 5DD

Funders/Sponsors


The study is sponsored by University of York (UK) and funded by Department for International Development (DFID) (UK) .



We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?

Read full details

for Trial ID: ISRCTN88319802

Last updated

This page is to help you find out about a research study and if you may be able to take part

The information is provided by researchers and we rely on them to keep it up-to-date. You can see more information by clicking on the 'Read full details' link above.

To take part, please print or share the study information with your GP/healthcare provider or contact the research team directly.