Completed PHASE1 INTERVENTIONAL 4-arm NCT03075956

Safety, Tolerability and Pharmacokinetics of Estetrol (E4) After Single and Multiple Oral Doses in Healthy Female Volunteers

An Open-label, Single Center, Randomized, Two Period Study to Characterize the Safety, Tolerability and Pharmacokinetics (PK) of Estetrol (E4) After Single and Multiple Oral Doses in Healthy Female Volunteers

Sponsor: Estetra

Conditions Contraception Menopause

Interventions 15 mg E4 multiple-dose 15 mg E4 single-dose 45 mg E4 single-dose 5 mg E4 single-dose

Updated 6 times since 2017 Last updated: Sep 7, 2017 Started: Jan 31, 2017 Primary completion: Aug 2, 2017 Completion: Aug 2, 2017

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03075956, this PHASE1 trial focuses on Contraception and Menopause and remains completed. Sponsored by Estetra, it has been updated 6 times since 2017, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1
Oct 2017 — Jun 2018 [monthly]

Completed PHASE1

Status: Recruiting → Completed

▶ Show 1 earlier version

Apr 2017 — Oct 2017 [monthly]

Recruiting PHASE1

First recorded

Jan 2017

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Estetra

Data source: Estetra

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Sofia, Bulgaria