CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 50 enrolled
Drug / intervention
50mcg estradiol cream +1 moredrug
Likely dose
50 mcg or 100 mcg estradiol cream applied nightly to the vulvar vestibuleAI-extracted
Key inclusion· 7
  • ✓Postmenopausal women aged 40-70 years
  • ✓Postmenopausal status confirmed by cessation of menses ≥1 year (if age >50), bilateral oophorectomy, or climacteric history with scarred/absent uterus (if age <50)
  • ✓Onset of dyspareunia after menopause
  • ✓Stable heterosexual partnership ≥2 years (or by investigator discretion if shorter) with both partners desiring more satisfying penetrative intimacy
Key exclusion· 8
  • ✕Deep dyspareunia (consistent pelvic or low abdominal pain during or after intercourse)
  • ✕Negative cotton-swab touch test in vulvar vestibule or vestibular tenderness not relieved by lidocaine 4% topical application for 3 minutes
  • ✕Partner with sexual dysfunction limiting performance or consistency (though male erectile dysfunction therapy is acceptable)
  • ✕Significant pelvic floor muscle tension/myalgia or pelvic/bladder tenderness on examination

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03240081
NCT03240081Phase 4Completed
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Treating Where it Hurts: A Randomized Blinded Clinical Trial of Local Estrogen to the Vulvar Vestibule for Dyspareunia in Postmenopausal Women

Oregon Health and Science University·interventional·Posted Aug 4, 2017·Updated May 22, 2023

In Brief

A Phase 4 clinical trial evaluating 50mcg estradiol cream and 100mcg estradiol cream for Dyspareunia. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDyspareunia
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedAug 4, 2017
Enrollment StartJun 20, 2017
Primary CompletionNov 21, 2019
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 8.9 years ago

Interventions

50mcg estradiol creamdrug

Use of study drug nightly applied to vulvar vestibule

100mcg estradiol creamdrug

Use of study drug nightly