Use of Estriol at Distal Third of Vagina Improving Coital Pain in Post-menopause Women

What this trial studies

Hypoestrogenism leads to vaginal wall changes resulting in diminished vaginal lubrication and, consequently, causing pain during intercourse. Topical estrogen therapy (THT) may control this complaint. However, there are limitations on its use, especially in patients with breast cancer and diagnosed endometrial cancer. This randomized clinical trial aims to assess the impact of local estriol therapy in postmenopausal women complaining of coital pain and to assess serum concentrations of estriol in these women after estriol use.

Conditions in scope

• Dyspareunia
• Menopause
• Sexual Dysfunction

Interventions

• Estriol (Drug) — Women using drug 1 mg / 1g in the proximal third of the vagina every other night for 12 weeks
• Distal estriol (Drug) — Women using drug 1 mg / 1g at the distal third of the vagina every other night for 12 weeks
• Vaginal Gel (Drug) — Women using a base water gel lubricant during intercourse

Who can join

Women only · Ages 40 Years to 65 Years · Accepts healthy volunteers.

Inclusion criteria

• Women with a clinical diagnosis of menopause
• FSH\> 40 milli-International unit (mIU/ml)
• Having sex including penetration of penis into vagina
• Pain during penetration
• Active sexual partners
• Stable relationship.

Exclusion criteria

• Previous use of steroids in genital area in the last month
• Thromboembolism history
• Renal insufficiency
• Cholestatic jaundice
• Degenerative vulvar pathology
• Breast cancer
• Endometrial cancer
• Vulvar cancer

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE1
• Start date: 2017-06-01
• Primary completion: 2018-12-31
• Last update posted: 2024-10-16
• First posted: 2017-04-14

Sponsor & contact

Lead sponsor: University of Sao Paulo (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Improvement in pain score after estriol use (baseline and 12 weeks)
  Number of women with lower score of pain assessed by the McGill Pain Questionnaire

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.