Development of UniPron as a safe microbicidal contraceptive

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR201303000491420
• Date of registration: 30/01/2013
• Primary sponsor: Institute of Primate Research
• Public title: Development of UniPron as a safe microbicidal contraceptive
• Scientific title: Contraceptive and safety studies of UniPron
• Date of first enrolment: 2013-05-31
• Target sample size: 5 and 60
• Recruitment status: Not yet recruiting
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201303000491420
• Study type: interventional
• Study design: 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,

Countries of recruitment

South Africa

Contacts

• Name: Peter Mwethera
• Affiliation: Institute of Primate Research

• Name: Walter Jaoko
• Affiliation: University of Nairobi

Key inclusion & exclusion criteria

Inclusion criteria: 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
Exclusion criteria: 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

Age minimum: 18 Year
Age maximum: 45 Year
Gender: Female

Health Condition(s) or Problem(s) studied

Contraceptive, safety studies

Primary Outcome(s)

Safety

Secondary Outcome(s)

Acceptability

Sperm function

Secondary ID(s)

None

Source(s) of Monetary Support

The Kenya Government

Secondary Sponsor(s)

The Aga Khan University Hospital

Universal Corporation Limited

University of Nairobi