NCT03240081

Treating Postmenopausal Dyspareunia Where it Hurts

Treating Where it Hurts: A Randomized Blinded Clinical Trial of Local Estrogen to the Vulvar Vestibule for Dyspareunia in Postmenopausal Women

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: Female
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Dyspareunia

Interventions

Type	Name	Description
DRUG	50mcg estradiol cream	Use of study drug nightly applied to vulvar vestibule
DRUG	100mcg estradiol cream	Use of study drug nightly

Timeline

• Start date: 2017-06-20
• Primary completion: 2019-11-21
• Completion: 2019-11-21
• First posted: 2017-08-04
• Last updated: 2023-05-22
• Results posted: 2021-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study