Safety of vaginal products used to prevent HIV/STDs
Conditions
Interventions
10 women were randomized to use placebo vaginal gel twice daily for 5.5 days. The vagina and cervix were examined using standard colposcopy and a new method, OCT, to determine the ability of OCT to d
Sponsors
Starpharma, Melbourne, Australia
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Provides written informed consent 2. Healthy female, 18-45 years of age 3. Pre-menopausal as defined by still having regular menstrual cycles and under age 46 years 4. Willing to discontinue use of vaginal products such as douches, drying agents, vaginal moisturizers, spermicides, tampons, and deodorant pads for 48 hours prior to their appointment and until completion of the study (i.e., from Day -2 to Day 13) 5. Willing to abstain from intercourse for 48 hours prior to Visit 1 until completion of the study (i.e., from Day -2 to Day 13)
Exclusion criteria
Exclusion criteria: 1. History of hysterectomy 2. Gynecologic surgery within the last year 3. History of sensitivity/allergy to any component of the study products, sexual lubricants, spermicides containing Nonoxynol-9, or similar products 4. Current vaginal, cervical, or bladder symptoms such as irritation, burning, itching 5. Current genital pain or discomfort 6. Currently pregnant or within two calendar months from the last pregnancy outcome (delivery, spontaneous abortion, induced abortion) 7. Currently breast-feeding 8. Positive urine pregnancy test 9. Known history of HIV infection 10. Have been diagnosed with any STIs in the 3 months prior to the screening visit or at the screening visit 11. Any evidence of an acute vaginal infection or STI 12. Abnormal Pap smear at screening visit 13. Currently using, or suspected to be using, injection drugs 14. Current use of a vaginal ring or intrauterine device (IUD) 15. Antibiotic use in the two weeks prior to Visit 1 16. Chronic systemic steroid use (does not exclude the use of topical or inhaled steroids) 17. Current diagnosis of cervical cancer or pre-cancer cells 18. Excessive irregular menstrual or inter-menstrual bleeding or unpredictable bleeding pattern (this would interfere with scheduling study visits at a time free from bleeding) 19. Has received an investigational product within 30 days or 5 half-lives (whichever is the longer) 20. Participant has knowledge that her partner is currently having a sexual relationship(s) with another person (male or female) 21. Participant has knowledge that her current partner(s): a. Has a history of HIV infection b. Had an STD within the last 6 months c. Is currently using, or is suspected to be using, injection drugs 22. Participant, in the opinion of the investigator, should not participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the score obtained for colposcopy and OCT for the cervix and vagina at Visit 2 compared to Visit 1. | — |
Countries
North America
Contacts
Public ContactKathleen L. Vincent, M.D.
University of Texas Medical Branch, Galveston, Texas, USA Department of Ob/Gyn
Outcome results
None listed