HIV/AIDS Fertility-female Contraceptive, safety studies
Conditions
Interventions
Placebo (Smugel) vaginal lubricating gel
UniPron vaginal gel
Sponsors
Institute of Primate Research
Universal Corporation Limited
The Aga Khan University Hospital
University of Nairobi
Eligibility
Sex/Gender
Female
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Acceptability;Sperm function | — |
Countries
Kenya
Contacts
Public ContactPeter Mwethera
Institute of Primate Research
Outcome results
None listed