A Trial to Evaluate the Efficacy of Low Dose Vaginal Estrogens in the Treatment of Atrophic Vaginitis
Status:
Terminated
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
Atrophic vaginitis is a common problem that occurs in up to 40% of postmenopausal women. The
main symptoms are dryness, itching and burning in and around the vagina. These symptoms in
turn can cause pain with intercourse. Other symptoms can include urinary frequency and
urinary urgency. These symptoms are caused by the decreasing levels of estrogens in
postmenopausal women.
The current treatment options include hormone replacement therapy by mouth and patch and
vaginal creams, tablets and rings. The current guideline recommend using hormone therapy at
the lowest dose for the shortest time. We are trying to find the lowest effective dose of
estrogen cream that helps with symptoms without causing an increase in estrogens in the blood
stream.
We want to compare two estrogen creams, estradiol and estriol, each at very low doses, with a
placebo cream. Estradiol cream is available on prescription but we want to see how effective
it is at one tenth the commonly prescribed dose. Estriol cream is not commonly prescribed and
is only available at compounding pharmacies. We want to see if either of these estrogens is
effective at one tenth the usual dose. We also want to see if these creams are effective when
massaged onto the outer part of the vagina, rather than the usual method of treatment, which
is inserting them into the vagina.
Phase:
Phase 3
Details
Lead Sponsor:
Maire Mac Bride
Collaborator:
National Center for Advancing Translational Science (NCATS)