At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 19 enrolled
Drug / intervention
Transdermal Estrogendrug
Likely dose
Transdermal Estrogen 25 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Primary Ovarian Insufficiency: Phenotype and Optimal Treatment
Children's Hospital Medical Center, Cincinnati·interventional·Posted Jun 26, 2018·Updated Jun 25, 2024
In Brief
A Phase 3 clinical trial evaluating Transdermal Estrogen for Primary Ovarian Insufficiency. Completed, enrolled 19 participants across 1 site.
Detailed Summary
This pilot study will observe the progression of newly diagnosed POI patients physical and psychology outcomes after initiating standard of care HRT treatment in comparison to healthy female control participants' physical and psychology health over 24 months.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Ovarian Insufficiency
CountriesUnited States
CollaboratorsPatty Brisben Foundation For Women's Sexual Health
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJun 2018
Enrollment StartNov 2018
Primary CompletionJan 2023
TodayJul 2026
First PostedJun 26, 2018
Enrollment StartNov 1, 2018
Primary CompletionJan 5, 2023
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 8.0 years ago
Interventions
Transdermal Estrogendrug
In an open-label fashion, participants with POI will receive transdermal estradiol (beginning at a dose of 25 µg/patch applied weekly), with the dose increased at 3, 6 12, and 18 months (to 37.5, 50, 75, and 100 µg/patch).