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

Completed

• Conditions: Sexually transmitted infection, human immunodeficiency virus (HIV) prevention; Infections and Infestations; Human immunodeficiency virus

• Registration Number: ISRCTN88319802
• Lead Sponsor: niversity of York (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-07
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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)

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
1. Assessment of the length of cervico-vaginal mucosa covered by gel<br>2. Visual assessment of the uniformity and distribution of gel within the genital tract