Topical Estriol for Vaginal Health
The purpose of this Phase I study is to investigate and document the effects of local treatment with a topical estriol cream on the vaginal environment of pre-menopausal women.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
|Official Title:||Topical Estriol for Vaginal Health|
- Change in thickness of the vaginal epithelium [ Time Frame: Pre and post treatment luteal and follicular phases ] [ Designated as safety issue: No ]
- Other vaginal parameters including Lactobacillus colonization and vaginal pH [ Time Frame: Pre and post treatment follicular and luteal phases ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
|Experimental: 1Topical estriol cream||
4 ml vaginal cream (1.0 mg estriol/1 ml cream), 3 days/week for approximately 2 months.
|Placebo Comparator: 2Placebo cream||
There is evidence from human studies that estrogen can give rise to health-promoting changes in the vaginal environment in addition to affecting the thickness of the vaginal epithelium. The purpose of the proposed study is to take the first steps in testing the effects of local estrogen treatment on vaginal health parameters in humans. We have chosen an estriol product because, in comparison with estrone (E1) and estradiol (E2), estriol (E3) is generally considered to be a weak estrogen. The duration of estriol's interaction with the estrogen receptor is quick and exhibits rapid metabolic clearance. We have chosen a topical route of administration because it appears to result in fewer systemic effects than oral administration, while allowing us to concentrate treatment locally in the areas we wish to affect.
Our primary goal is to test whether or not topically applied estrogen results in significant thickening and maturation of the vaginal epithelium. Our secondary goal is to measure the treatment's effects on other parameters of the vagina, such as Lactobacillus colonization and vaginal pH. If estrogen cream does indeed affect the vaginal environment in pre-menopausal women as it does in post-menopausal women, further study would be indicated to determine whether estrogen cream in the vagina decreases risk of infection in pre-menopausal women.
|United States, California|
|Harbor-UCLA Medical Center|
|Los Angeles, California, United States, 90502|
|United States, Illinois|
|University of Illinois at Chicago|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Yael Swica, M.D., M.P.H.||Gynuity Health Projects|