NCT03075956 - Safety, Tolerability and Pharmacokinetics of Estetrol (E4) After Single and Multiple Oral Doses in Healthy Female Volunteers | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 31, 2017

Primary Completion Date

August 2, 2017

Study Completion Date

August 2, 2017

Conditions

ContraceptionMenopause

Interventions

DRUG

5 mg E4 single-dose

A single oral dose of 5 mg E4 will be administered during Period 1 of the study.

DRUG

15 mg E4 single-dose

A single oral dose of 15 mg E4 will be administered during Period 1 of the study.

DRUG

45 mg E4 single-dose

A single oral dose of 45 mg E4 will be administered once orally during Period 1 of the study

DRUG

15 mg E4 multiple-dose

15 mg E4 will be administered once daily orally for 14 consecutive days during Period 2 of the study

Trial Locations (1)

COMAC, Sofia