Evaluation of Optical Coherence Tomography (OCT) as a Safety Tool for Assessment of Vaginal Products - SPOT (Safety of Products using Optical Technologies)
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Starpharma, Melbourne, Australia
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Vincent KL, Stanberry LR, Moench TR, Breitkopf CR, Loza ML, Wei J, Grady J, Paull J, Motamedi M, Rosenthal SL. Optical coherence tomography compared with colposcopy for assessment of vaginal epithelial damage: a randomized controlled trial. Obstet Gynecol. 2011 Dec;118(6):1354-61. Results: Colposcopy findings, optical coherence tomography scores, and epithelial thicknesses were similar between treatment groups at baseline. After treatment, there were significant differences between the nonoxynol-9 (1.37) and control group (1.15) optical coherence tomography scores (P<.001), indicating epithelial injury, and there was epithelial thinning in the nonoxynol-9 group (237 micrometers) compared with the control group (292 micrometers; P=.008). There were no significant posttreatment colposcopic differences in epithelial disruption between treatment groups, with only increased erythema noted after nonoxynol-9 use (P=.02). CONCLUSION: Optical coherence tomography detected epithelial disruption and thinning not identified by colposcopy. Vaginal epithelial thickness, a measure previously available only through biopsy, decreased after nonoxynol-9 use, a finding that may contribute to increased susceptibility to human immunodeficiency virus after frequent use. Optical coherence tomography shows promise for the noninvasive clinical assessment of vaginal epithelial damage.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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
Outcomes
Primary Outcomes
Not specified