NCT03699176 (ASTEROID 7) is a Phase 3 clinical trial of Vilaprisan (BAY1002670) in Uterine Fibroids, sponsored by Bayer.

Who is sponsoring NCT03699176?

NCT03699176 is sponsored by Bayer.

What drugs are being tested in NCT03699176?

Interventions in NCT03699176: Vilaprisan (BAY1002670), Placebo.

What condition does NCT03699176 study?

NCT03699176 studies Uterine Fibroids.

Is NCT03699176 still recruiting?

NCT03699176 is currently withdrawn. Last updated 18 January 2020.

Last reviewed 2020-01-18 · How we verify

NCT03699176: ASTEROID 7

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

Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids

Withdrawn Phase 3 Last updated 18 January 2020

What this trial tests

Phase 3 trial testing Vilaprisan (BAY1002670) in Uterine Fibroids. Withdrawn.

Timeline

27 October 2018

Primary endpoint
25 December 2019

25 December 2019

Quick facts

Lead sponsor	Bayer
Phase	Phase 3
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Start date	27 October 2018
Primary completion	25 December 2019
Estimated completion	25 December 2019
Sites	8 locations across Japan

Drugs / interventions tested

Vilaprisan (BAY1002670) — full drug profile →
Placebo

Conditions studied

Uterine Fibroids — all drugs for Uterine Fibroids →

Sponsor

Bayer — full company profile →

Who can join

18 and older, female only, with Uterine Fibroids. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objective of this study is to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo.The secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.

Publications & conference data

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

Selective Progesterone Receptor Modulators-Mechanisms and Therapeutic Utility.
Islam MS, Afrin S, Jones SI, Segars J. · · 2020 · cited 97× · PMID 32365199 · DOI 10.1210/endrev/bnaa012
Progesterone Signaling and Uterine Fibroid Pathogenesis; Molecular Mechanisms and Potential Therapeutics.
Ali M, Ciebiera M, Vafaei S, Alkhrait S, et al · · 2023 · cited 30× · PMID 37190026 · DOI 10.3390/cells12081117

Verify or expand the search:

Other trials of Vilaprisan (BAY1002670)

Trials testing the same drug.

NCT03573336 — Assess Safety and Efficacy of Vilaprisan in Subjects With Endometriosis · Phase 2 · terminated
NCT03476928 — A Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual B · Phase 3 · terminated
NCT03411980 — Pharmacokinetics and Safety of Vilaprisan in Renal Impairment · Phase 1 · completed
NCT03400956 — Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4) · Phase 3 · terminated
NCT03400943 — Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3) · Phase 3 · terminated

Other recruiting trials for Uterine Fibroids

Currently open trials in the same condition.

NCT07378098 — to Evaluate the Efficacy and Safety of KLH-2109 in Patients With Uterine Fibroids and Menorrhagia · Phase 3 · recruiting
NCT07486622 — Transvaginal Electromechanical Fragmentation and Removal of Large Uterus in a Sealed Bag: The First Group of Clinical St · active not recruiting
NCT06671548 — Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids · Phase 3 · recruiting
NCT05448365 — Vitamin D, Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in Uterine Fibroid · NA · recruiting
NCT04126824 — Effect of Addition of Steroids on Duration of Analgesia · EARLY_PHASE1 · active not recruiting

Other Bayer trials

Trials by the same sponsor.

NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting

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 NCT03699176 (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 Bayer
Last refreshed: 18 January 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/NCT03699176.

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