CI

At a glance

ClinicalIndex Comparison Record
Phase 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.

Search/NCT02720224
NCT02720224Phase 1Completed

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

Estetra·interventional·Posted Mar 25, 2016·Updated Feb 15, 2019

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--
CountriesUnited Kingdom
CollaboratorsQuotient Clinical

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
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