Who is sponsoring NCT00361036?

NCT00361036 is sponsored by Worthington-Kirsch, Robert L., M.D..

What drugs are being tested in NCT00361036?

Interventions in NCT00361036: Uterine fibroid embolization BeadBlock™, Uterine fibroid embolization Embosphere®.

What condition does NCT00361036 study?

NCT00361036 studies Leiomyoma, Leiomyomatosis, Uterine Neoplasms.

Is NCT00361036 still recruiting?

NCT00361036 is currently completed. Last updated 14 April 2011.

Last reviewed 2011-04-14 · How we verify

NCT00361036

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

Feasibility Evaluation of the Embolic Agent BeadBlock™ in the Treatment of Uterine Fibroids With Uterine Artery Embolization With Comparison of Study Endpoints to Embosphere®

Completed Phase 1 Last updated 14 April 2011

What this trial tests

Phase 1 trial testing Uterine fibroid embolization BeadBlock™ in Leiomyoma in 44 participants. Completed in 1 March 2010.

Timeline

1 August 2006

Primary endpoint
1 March 2010

1 March 2010

Quick facts

Lead sponsor	Worthington-Kirsch, Robert L., M.D.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	44
Start date	1 August 2006
Primary completion	1 March 2010
Estimated completion	1 March 2010
Sites	2 locations across United States

Drugs / interventions tested

Uterine fibroid embolization BeadBlock™
Uterine fibroid embolization Embosphere®

Conditions studied

Leiomyoma — all drugs for Leiomyoma →
Leiomyomatosis — all drugs for Leiomyomatosis →
Uterine Neoplasms — all drugs for Uterine Neoplasms →

Sponsor

Worthington-Kirsch, Robert L., M.D.

Who can join

Adults 30 to 50, female only, with Leiomyoma or Leiomyomatosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change in fibroid devascularization as seen at contrast enhanced MRI performed several days after UAE and 3 months following the UAE between BeadBlock™ and Embosphere
Time frame: 12 months

Sponsor's own description

A double arm (non-inferiority) 44 patient study to assess the performance of BeadBlock™ in the treatment of uterine fibroids by embolization with respect to clinical \& imaging outcome with comparison of primary safety endpoints to Embosphere.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Leiomyoma

Currently open trials in the same condition.

NCT06143631 — Prescription of Letrozole for Uterine Myoma · Phase 4 · recruiting
NCT06135870 — Role of Senescent Cells in Uterine Fibroid Pathogenesis (SOUL Study) · recruiting
NCT03400826 — Effects of Simvastatin on Uterine Leiomyoma Size · Phase 2 · 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 NCT00361036 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Worthington-Kirsch, Robert L., M.D.
Last refreshed: 14 April 2011

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/NCT00361036.

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