At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 6 enrolled
Drug / intervention
Estetroldrug
Likely dose
Estetrol 15 mgfrom 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.
An Open-Label, Single Dose Study Designed to Assess the Mass Balance Recovery, Metabolite Profiles and Metabolite Identification of [14C]-Estetrol in Healthy Female Volunteers
In Brief
A Phase 1 clinical trial evaluating Estetrol for Contraception and Menopause. Completed, enrolled 6 participants across 1 site.
Detailed Summary
This study is being conducted to further understand the elimination pathways, metabolite profile and pharmacokinetic (PK) profile of carbon 14 labelled estetrol (\[14C\] estetrol).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContraception, Menopause
CountriesUnited Kingdom
CollaboratorsQuotient Clinical
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartFeb 2016
Primary CompletionMar 2016
First PostedMar 2016
Study CompletionApr 2016
TodayJul 2026
First PostedMar 25, 2016
Enrollment StartFeb 1, 2016
Primary CompletionMar 1, 2016
Study CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 10.3 years ago
Interventions
Estetroldrug
15 mg \[14C\]-estetrol containing approximately 2.8 MBq (76 μCi) 14C