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Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR201303000491420 Date registered: 2013/01/30
TRIAL DESCRIPTION
Public title Development of UniPron as a safe microbicidal contraceptive
Official scientific title Contraceptive and safety studies of UniPron
Brief summary describing the background
and objectives of the trial
While the condom is effective in preventing unwanted pregnancies and sexually transmitted infections (STIs), women have little power to negotiate its use due to social and economic reasons. Vaginal contraceptive products which have been available have cytotoxic effect on vaginal cells thereby increase women vulnerability to infections with STIs including HIV. The study aims to evaluate the effect of UniPron on human semen in vitro, and safety and acceptability studies when applied vaginally.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) None
Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 2013-04-30
Actual trial start date 2013-05-31
Anticipated date of last follow up 2013-07-31
Actual date of last follow up 2013-08-31
Anticipated target sample size (number of participants) 10 80   
Actual target sample size (number of participants) 65   
Recruitment status Not yet recruiting
Secondary Ids Issuing authority/Trial register Links to Secondary ID
None None

STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person
allocating the participants to the intervention arms
Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Allocation sequence will be computer generated The holder of the sequence will be situated off site Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group UniPron vaginal gel 5ml, twice daily, 12 hours interval 14 days 5ml UniPron gel in single use prefilled applicators composed of 0.8g citric acid, carbomer, sodium benzoate, sodium carboxymethyl cellulose, EDTA, disodium hydrogen phosphate, purified water 15
Experimental group UniPron vaginal gel 5ml, twice daily, 12 hours interval 14 days 5ml UniPron gel in single use prefilled applicators composed of 1.2g citric acid, carbomer, sodium benzoate, sodium carboxymethyl cellulose, EDTA, disodium hydrogen phosphate, purified water 15
Control group Placebo (Smugel) vaginal lubricating gel 5ml, twice daily, 12 hours interval 14 days 5ml Smugel gel in prefilled single use applicators composed of carbomer, sodium benzoate, glycerine, EDTA, purified water 15 Placebo
Experimental group UniPron vaginal gel 5ml, twice daily, 12 hours interval 14 days 5ml UniPron gel in single use prefilled applicators composed of 0.4g citric acid, carbomer, sodium benzoate, sodium carboxymethyl cellulose, EDTA, disodium hydrogen phosphate, purified water 15

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
HIV negative Willing and able to maintain sexual abstinence during study period Not pregnant (based on negative urine pregnancy results Negative screen for STIs Adequate general and gynaecologic heath Willing to abstain from using any vaginal products (other than the study product or placebo Normal pap smear at screening or documentation of such within six months Agree to pelvic exam, colposcopy and biopsy if indicated Willing to complete study Agree to apply assigned study gel as required by protocol Willing to participate and sign an informed consent form Having normal menstrual cycle defined as having a minimum of 21 days and a maximum 36 days between menses Availability to return for all study visits, barring unforeseen circumstances Anticipate 10 men for invitro semen analysis and 60 women for safety studies Currently pregnant of breastfeeding Clinically detectable genital abnormality on the vulva, vaginal walls or cervix Laboratory confirmed STIs, chlamydia, trichomonas, syphilis or vaginal candidiasis or clinically diagnosed genitourinary disease (GUD) or active HSV-2 lesion Symptomatic bacterial vaginosis at screening and unwilling to undergo treatment Using another intravaginal preparation History of genital ulcer disease History of severe allegic reactions HIV positive Not willing to adhere to the study protocol Have received antibiotics 14 days prior to enrollment Have used a spermicide or spermicidal lubricated condom within 7 days prior to enrollment Grade 3 or higher liver, renal or hematology abnormality as defined by the table for grading severity of Adult Adverse Events at screening Grade 3 or higher exam pelvic finding Any condition that, in the opinion of the investigator would interfere with the study Have douched or used vaginal products, including lubricants, feminine hygiene products, vaginal drying agents and sex toys 48 hours prior to study entry Received treatment for candida, bacterial vaginosis or urinary tract infections within one month prior to the study entry Previous gynecologic surgery or have received treatment for syphilis, genital herpes, chlamydia, gonorrhea, trichomonas or genital warts within 6 months prior to study entry History of intermenstrual bleeding within 3 months prior to study entry Currently using hormonal contraception or have used hormonal contraceptive within two months of study entry Currently participating in a research study of other vaginal products Pregnant, less than 6 months postpartum, or breastfeeding Menstruating at screening or enrollment visits 18 Years 45 Years Female

ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
No 2013/02/04 The Aga Kha University Hospital
Ethics Committee Address
Street address City Postal code Country
Stadium Road Karachi 74800 Pakistan

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Safety At enrollment Day 8 Day 15 Day 21
Secondary Outcome Acceptability Day 8 Day 15 Day 21
Secondary Outcome Sperm function Baseline 15 minutes 30 minutes 45 minutes 1 hour 1 hour 15 minutes 1 hour 30 minutes

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
The Aga Khan University Hospital 3rd Parklands Avenue Nairobi 00100 Kenya
University of Nairobi, Kenyatta National Hospital Off Ngong Road Nairobi 00202 Kenya

FUNDING SOURCES
Name of source Street address City Postal code Country
The Kenya Government None Nairobi None Kenya

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor University of Nairobi Off Ngong Road Nairobi 00202 Kenya University
Secondary Sponsor Universal Corporation Limited Club Road Nairobi 00902 Kenya Company
Primary Sponsor Institute of Primate Research End of Karen Road Nairobi 00502 Kenya Foundation
Secondary Sponsor The Aga Khan University Hospital 3rd Parklands Avenue Nairobi 00100 Kenya University

COLLABORATORS
Name Street address City Postal code Country
Dr. Alfred Murage 3rd Parklands Avenue Nairobi 00100 Kenya
Dr. Peter Mwethera End of Karen Road Nairobi 00502 Kenya
Dr. Kavoo Linge Argwings Kodhek Road Nairobi 00100 Kenya
Ms. Jael Obiero End of Karen Road Nairobi 00502 Kenya
Mr. Palu Dhanani Club Road Nairobi 00902 Kenya
Prof. William Stones 3rd Parklands Avenue Nairobi 00100 Kenya
Prof. Walter Jaoko Off Ngong Road Nairobi 00202 Kenya

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Prof William Stones william.stones@aku.edu +254 20 366 2000 +254 20 778 8320
Street address City Postal code Country Position / Affiliation
3rd Parklands Avenue Nairobi 00100 Kenya The Aga Khan Universtity Hospital
Role Name Email Phone Fax
Public Enquiries Dr Peter Mwethera mwethera@ primateresearch.org +254 20 2606235 +254 20 2606231
Street address City Postal code Country Position / Affiliation
End of Karen Road Nairobi 00502 Kenya Institute of Primate Research
Role Name Email Phone Fax
Scientific Enquiries Prof Walter Jaoko wjaoko@kaviuon.org +254 20 2714851 +254 20 272 8860
Street address City Postal code Country Position / Affiliation
Off Ngong Road Nairobi 00202 Kenya University of Nairobi