NCT00580424 is a NA clinical trial of Norethindrone in Women's Health, sponsored by University of Vermont.

Who is sponsoring NCT00580424?

NCT00580424 is sponsored by University of Vermont.

What drugs are being tested in NCT00580424?

Interventions in NCT00580424: Norethindrone.

What condition does NCT00580424 study?

NCT00580424 studies Women's Health, Blood Coagulation Disorders.

Is NCT00580424 still recruiting?

NCT00580424 is currently terminated. Last updated 24 June 2010.

Last reviewed 2010-06-24 · How we verify

NCT00580424

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

The Effect of Oral Norethindrone on Coagulation Parameters in Women at Increased Risk for Venous Thromboembolic Events

Terminated NA Last updated 24 June 2010

What this trial tests

NA trial testing Norethindrone in Women's Health in 20 participants. Terminated before completion.

Timeline

1 December 2007

1 July 2009

Quick facts

Lead sponsor	University of Vermont
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	20
Start date	1 December 2007
Estimated completion	1 July 2009
Sites	1 location across United States

Drugs / interventions tested

Norethindrone — full drug profile →

Conditions studied

Women's Health — all drugs for Women's Health →
Blood Coagulation Disorders — all drugs for Blood Coagulation Disorders →

Sponsor

University of Vermont

Who can join

Adults 18 to 52, female only, with Women's Health or Blood Coagulation Disorders. 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.

The primary outcome of this study will be change in coagulation parameters. The proposed sample size of 20 subjects was derived based on having sufficient power to detect a 40% change in the variable D-dimer, a lab measurement.
Time frame: 2 years

Sponsor's own description

We propose a prospective cohort study to assess the effect of the progesterone only contraceptive pill (minipill) on coagulation parameters known to be associated with risk of thrombosis (blood clots) in women who are at increased risk for forming blood clots. We plan to recruit women with a history of venous thromboembolism (VTE, blood clot in a vein) and women with a history of blood tests which demonstrate an increased risk of thrombosis who desire contraception. Women enrolled in this study will undergo phlebotomy (blood draw) at baseline (prior to starting the minipill), one and three months. Stored samples will be used to measure D-dimer, C-reactive protein (CRP), antithrombin (AT), factor VIII, free and total protein S, fibrinogen, von Willebrand factor (vWF) and normalized activated protein C sensitivity ratio (nAPCsr). Both groups will undergo a general physical and GYN exam prior to enrollment. This exam and the blood testing will be provided free of charge. Patients will not be prescribed the minipill after completion of the study and will be advised to consult with their primary care physician or hematologist if they wish to continue this medication.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Norethindrone

Trials testing the same drug.

NCT03594604 — Norethindrone for the Delay of Menstruation · Phase 4 · completed

Other recruiting trials for Women's Health

Currently open trials in the same condition.

NCT05910580 — Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years · NA · recruiting
NCT07003789 — Co-Developing an HIV Prevention Program for Women in Ghana · NA · active not recruiting
NCT06212349 — Therapeutic-educational Physiotherapy on Pain, Physical-functionality and Quality of Life in Women With Endometriosis. · NA · recruiting

Other University of Vermont trials

Trials by the same sponsor.

NCT07495098 — Phase 1B Trial of Intratumoral Cisplatin for Stage IV Lung Cancer · Phase 1 · not yet recruiting
NCT07440641 — RE-FIT (Remote Exercise for Physical Function in WTC Responders With Prostate Cancer) · NA · not yet recruiting
NCT06993129 — A Multi-Site Hybrid Type I Effectiveness-Implementation Randomized Trial of an Emergency Care Action Plan for Infants Wi · NA · not yet recruiting
NCT07383727 — Readiness to Change and the Implementation of Home Modifications for Adults Over 60 · NA · not yet recruiting
NCT06670079 — Prolonged Exposure Therapy to Treat Posttraumatic Stress Disorder in Pregnant Patients · NA · 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 NCT00580424 (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 University of Vermont
Last refreshed: 24 June 2010

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/NCT00580424.

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