Vaginal Health Clinical Trial
Official title:
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.
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.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
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