VG101 Phase I/II to Treat Vulvar and Vaginal Atrophy in Post-Menopausal Women (NCT00453089) | Clinical Trial Compass
UnknownPhase 1/2
VG101 Phase I/II to Treat Vulvar and Vaginal Atrophy in Post-Menopausal Women
United States40 participantsStarted 2012-06
Plain-language summary
To conduct a prospective, randomized, blinded, placebo controlled, dose escalation clinical trial in 4 cohorts of 10 postmenopausal women (total N=40) aged 45 to 65 years with at least one menopausal vaginal symptom, vaginal pH \> 5.0 and \> 20% parabasal vaginal epithelial cells.
Who can participate
Age range45 Years – 65 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Women between the ages of 45 and 65
✓. Postmenopausal documented by: (a) at least one year of amenorrhea; (b) 6- 12 months of amenorrhea with serum FSH \> 40 IU/ml; (c) 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy, or (d) hysterectomy with serum FSH levels \> 40 IU/ml.
✓. Self-report at least one moderate to severe symptom of vulvar or vaginal atrophy from the following list:
✓. \< 5% superficial cells on vaginal cytologic smear.
✓. Vaginal pH \>5.0
✓. Willing to use an intravaginal cream containing Chinese herbs for the treatment of vaginal symptoms.
✓. Provide informed consent.
Exclusion criteria
✕. History of breast, uterine or ovarian cancer or melanoma.
✕. Abnormal mammogram or breast examination within the last 9 months suggestive of cancer.
✕. Abnormal Pap smear or pelvic examination within the last 9 months suggestive of cancer.
✕. Any uterine or vaginal bleeding within the six months prior to enrollment (except following the screening Pap smear).
✕. Double-wall endometrial thickness that exceeds 5 mm measured on transvaginal ultrasound.
What they're measuring
1
Change in self-reported symptoms of vaginal atrophy from baseline to 12 weeks
Timeframe: 4 and 12 weeks
2
Change in percent superficial vaginal epithelial cells from baseline 12 weeks
Timeframe: 4 and 12 weeks
3
Change in the pH of vaginal secretions from baseline to 12 weeks