Who is sponsoring NCT00503581?

NCT00503581 is sponsored by Gynecologic Oncology Group.

What drugs are being tested in NCT00503581?

Interventions in NCT00503581: Biopsy, Laboratory Biomarker Analysis, Megestrol Acetate, Pharmacological Study, Quality-of-Life Assessment, Therapeutic Conventional Surgery.

What condition does NCT00503581 study?

NCT00503581 studies High Grade Squamous Intraepithelial Neoplasia, Stage 0 Uterine Corpus Cancer.

Is NCT00503581 still recruiting?

NCT00503581 is currently terminated. Last updated 14 October 2020.

Are results published for NCT00503581?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-10-14 · How we verify

NCT00503581

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

A Randomized Phase II Evaluation of Continuous Progestin Therapy vs. Sequential Progestin Therapy in the Treatment of Endometrial Intraepithelial Neoplasia (EIN) From a Referred Cohort of Atypical Endometrial Hyperplasia (AEH) or EIN Patients That Desire Uterine Preservation

Terminated Phase 2 Results posted Last updated 14 October 2020

What this trial tests

Phase 2 trial testing Biopsy in High Grade Squamous Intraepithelial Neoplasia in 9 participants. Terminated before completion.

Timeline

1 July 2007

Primary endpoint
1 July 2012

Quick facts

Lead sponsor	Gynecologic Oncology Group
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	1 July 2007
Primary completion	1 July 2012
Sites	50 locations across United States

Drugs / interventions tested

Biopsy — full drug profile →
Laboratory Biomarker Analysis — full drug profile →
Megestrol Acetate (MEGESTROL ACETATE) — full drug profile →
Pharmacological Study — full drug profile →
Quality-of-Life Assessment
Therapeutic Conventional Surgery

Conditions studied

High Grade Squamous Intraepithelial Neoplasia — all drugs for High Grade Squamous Intraepithelial Neoplasia →
Stage 0 Uterine Corpus Cancer — all drugs for Stage 0 Uterine Corpus Cancer →

Sponsor

Gynecologic Oncology Group — full company profile →

Who can join

18 and older, female only, with High Grade Squamous Intraepithelial Neoplasia or Stage 0 Uterine Corpus Cancer. 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.

Number of Patients Who Experience a Response as Determined by a Central Blinded Review of the Three Post Treatment Endometrial
Time frame: Up to 12 months after completion of treatment
Treated and eligible participants. This study had 0 participants that completed treatment, therefore no analysis was done. Study closed prior to completion. Central blinded review was not performed for any participants in the study.

Sponsor's own description

This randomized phase II trial is studying how well megestrol works in treating patients with endometrial neoplasia or endometrial hyperplasia. Estrogen can cause the growth of endometrial cancer cells. Hormone therapy using megestrol may fight endometrial cancer by blocking the use of estrogen by the abnormal cells.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Biopsy

Trials testing the same drug.

NCT06675123 — Pacritinib in Combination With a BTK Inhibitor for the Treatment of Patients With Relapsed or Refractory Mantle Cell Lym · Phase 1 · recruiting
NCT06670976 — Propranolol Plus Standard Radiation Therapy Before Surgery for the Treatment of Patients With Soft Tissue Sarcoma · Phase 1 · withdrawn
NCT07217990 — Neoadjuvant Complete Response Customized Treatment Approach for Definitive Management of Breast Cancer · Phase 1, PHASE2 · not yet recruiting
NCT06860815 — Cemiplimab and Transarterial Radioembolization With Y-90 SIR-S Spheres for the Treatment of Liver Directed Metastatic Br · Phase 2 · recruiting
NCT05741164 — Propranolol and Pembrolizumab for Tumor Re-sensitization and Treatment of Patients With Checkpoint Inhibitor Refractory · Phase 2 · not yet recruiting

Other Gynecologic Oncology Group trials

Trials by the same sponsor.

NCT04393285 — Abemaciclib and Letrozole to Treat Endometrial Cancer · Phase 2 · active not recruiting
NCT03673124 — Ribociclib and Letrozole Treatment in Ovarian Cancer · Phase 2 · active not recruiting
NCT02065687 — Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent · Phase 2, PHASE3 · unknown
NCT01720173 — Dalantercept in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer · Phase 2 · completed
NCT01406769 — Bioimpedance Spectroscopy in Detecting Lower-Extremity Lymphedema in Patients With Stage I, Stage II, Stage III, or Stag · Phase 2 · 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 NCT00503581 (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 Gynecologic Oncology Group
Last refreshed: 14 October 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/NCT00503581.

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