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: pactr.samrc.ac.za
Trial no.: PACTR201303000491420 Date of Approval: 30/01/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
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 Contraceptive, safety studies,Infections and Infestations,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female,HIV/AIDS
Purpose of the trial Prevention
Anticipated trial start date 30/04/2013
Actual trial start date 31/05/2013
Anticipated date of last follow up 31/07/2013
Actual Last follow-up date 31/08/2013
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 65
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
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
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
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum 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 Year(s) 45 Year(s) 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 04/02/2013 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
University of Nairobi, Kenyatta National Hospital Off Ngong Road Nairobi 00202 Kenya
The Aga Khan University Hospital 3rd Parklands Avenue Nairobi 00100 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 Universal Corporation Limited Club Road Nairobi 00902 Kenya Commercial Sector/Industry
Primary Sponsor Institute of Primate Research End of Karen Road Nairobi 00502 Kenya Charities/Societies/Foundation
Secondary Sponsor The Aga Khan University Hospital 3rd Parklands Avenue Nairobi 00100 Kenya University
Secondary Sponsor University of Nairobi Off Ngong Road Nairobi 00202 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Prof. William Stones 3rd Parklands Avenue Nairobi 00100 Kenya
Prof. Walter Jaoko Off Ngong Road Nairobi 00202 Kenya
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
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator William Stones william.stones@aku.edu +254 20 366 2000 3rd Parklands Avenue
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya The Aga Khan Universtity Hospital
Role Name Email Phone Street address
Public Enquiries Peter Mwethera mwethera@primateresearch.org +254 20 2606235 End of Karen Road
City Postal code Country Position/Affiliation
Nairobi 00502 Kenya Institute of Primate Research
Role Name Email Phone Street address
Scientific Enquiries Walter Jaoko wjaoko@kaviuon.org +254 20 2714851 Off Ngong Road
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya University of Nairobi
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information