AME assessment of 14C Estetrol in Healthy Female Volunteers (114621)
Research type
Research Study
Full title
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
IRAS ID
190056
Contact name
Françoise Bruyère
Contact email
Sponsor organisation
Estetra Sprl
Eudract number
2014-000622-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 9 days
Research summary
The Sponsor is developing the study drug, estetrol, as a Hormone Replacement Therapy (HRT) for the relief of vasomotor symptoms (hot flushes) in post-menopausal women and as a combined oral contraceptive (COC) in combination with progestin. Estetrol is a naturally occurring oestrogen (primary female sex hormone) only produced by the human foetal (unborn baby) liver during pregnancy and reaching the maternal circulation through the placenta (an organ developed during pregnancy to provide nutrient and oxygen to the unborn baby).
The study aims to characterise the absorption, metabolism and excretion of the study drug in healthy female volunteers. Safety and tolerability information will also be collected.
The study will consist of a single study period involving up to 6 female subjects. Each subject will receive a single oral dose of 15 mg [14C]-Estetrol as a solution, following an overnight fast. Subjects will remain resident in the clinical unit for assessment up to 240h (Day 11), or earlier if study requirements are met.
REC name
Wales REC 1
REC reference
15/WA/0353
Date of REC Opinion
10 Dec 2015
REC opinion
Further Information Favourable Opinion