NCT03709420 is a Phase 1 clinical trial of FOR-6219 in Endometriosis, sponsored by Forendo Pharma Ltd.

Who is sponsoring NCT03709420?

NCT03709420 is sponsored by Forendo Pharma Ltd.

What drugs are being tested in NCT03709420?

Interventions in NCT03709420: Placebo, FOR-6219.

What condition does NCT03709420 study?

NCT03709420 studies Endometriosis.

Is NCT03709420 still recruiting?

NCT03709420 is currently completed. Last updated 18 November 2020.

Last reviewed 2020-11-18 · How we verify

NCT03709420

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Investigate the Safety, Tolerability, Food Effect, Pharmacokinetics and Pharmacodynamics of FOR-6219

Completed Phase 1 Last updated 18 November 2020

What this trial tests

Phase 1 trial testing Placebo in Endometriosis in 87 participants. Completed in 11 November 2020.

Timeline

13 August 2018

Primary endpoint
11 November 2020

11 November 2020

Quick facts

Lead sponsor	Forendo Pharma Ltd
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	treatment
Enrollment	87
Start date	13 August 2018
Primary completion	11 November 2020
Estimated completion	11 November 2020
Sites	1 location across United Kingdom

Drugs / interventions tested

Placebo
FOR-6219 — full drug profile →

Conditions studied

Endometriosis — all drugs for Endometriosis →

Sponsor

Forendo Pharma Ltd — full company profile →

Who can join

Adults 18 to 65, female only, with Endometriosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a randomised, double-blind, placebo-controlled, Phase I/Ib study which will assess the safety, tolerability, food effect, pharmacokinetics and pharmacodynamics of FOR-6219, a hydroxysteroid (17B) dehydrogenase (HSD17B1) inhibitor. The study will be performed in three parts: (I) Single ascending doses (SAD) in healthy post-menopausal women; (II) multiple ascending doses (MAD) in post-menopausal women; (III) multiple ascending doses in healthy pre-menopausal women.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting the formation of estrogens for treatment of hormone dependent diseases-current status.
Rižner TL, Romano A. · · 2023 · cited 16× · PMID 37188267 · DOI 10.3389/fphar.2023.1155558
Is intracrinology of endometriosis relevant in clinical practice? A systematic review on estrogen metabolism.
Mercorio A, Giampaolino P, Romano A, Dällenbach P, et al · · 2022 · cited 9× · PMID 36204107 · DOI 10.3389/fendo.2022.950866
Endometriosis is not the endometrium: Reviewing the over-representation of eutopic endometrium in endometriosis research.
Gunther K, Fisher T, Liu D, Abbott J, et al · · 2025 · cited 6× · PMID 40392231 · DOI 10.7554/elife.103825
The Hallmarks of Endometriosis.
Psilopatis I, Burghaus S, Au K, Hofbeck L, et al · · 2024 · cited 6× · PMID 38884026 · DOI 10.1055/a-2306-8759

Verify or expand the search:

Other recruiting trials for Endometriosis

Currently open trials in the same condition.

NCT06559852 — The Impact of Yoga on Endometriosis-Related Pain · NA · recruiting
NCT07393295 — Efficacy and Tolerability of TENS in Endometriosis-related Pain · NA · recruiting
NCT07134023 — Educational Program for the Multidisciplinary Support of Patients With Endometriosis · NA · recruiting
NCT07240883 — ENDO1000 - A UK-wide Endometriosis Research Project · recruiting
NCT06974773 — Remote Electrical Stimulation as a Long-term Intervention for Endometriosis Flare Ups · NA · recruiting

Other Forendo Pharma Ltd trials

Trials by the same sponsor.

NCT04686669 — A Relative Bioavailability Study of FOR-6219 in Capsule and Tablet Formulations · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03709420 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Forendo Pharma Ltd
Last refreshed: 18 November 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03709420.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing