The purpose of this study is to compare the effectiveness of two low doses of estrogen cream applied to a new location for the treatment of moderate or severe pain during sexual intercourse in postmenopausal women.
Estrogen cream is FDA-approved for vaginal use for the treatment of sexual pain, but its use in a new location is experimental. Pain with sex is a common problem experienced by women after menopause and the relationship of pain to sexual difficulties is well established. The cause has been assumed to be atrophy and the location has been assumed to be the vagina. Recent focused studies have shown that the location of pain is the vulvar vestibule and usually not the vagina. This study will look at pain before and after therapy with estrogen when only the vulvar entryway area is treated. This will be a study focused on sexual dysfunction in postmenopausal women.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Use of study drug nightly applied to vulvar vestibule
Use of study drug nightly
Oregon Health & Science Univerity
Portland, Oregon, United States
Change in Median Dyspareunia Pain Scores After 4 Weeks Using Study Drug
Change in median dyspareunia pain scores between baseline and 4 weeks of use of nightly use of study medication. Pain will be assessed using 11-point Numerical Rating Scale (NRS) where 0 = no pain and 10 = worst possible pain.
Time frame: Baseline to 4 weeks
Change in Median Pain Scores for Intercourse After 12 Weeks Using Study Drug
Difference in median dyspareunia pain scores between arms for intercourse at 12 weeks after use of nightly study medication for 90d. Pain will be assessed using 11-point Numerical Rating Scale (NRS) where 0 = no pain and 10 = worst possible pain.
Time frame: Baseline and 12 weeks
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