Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01280981 · ClinicalTrials.gov registry record · Phase 3

A Study of Tranexamic Acid (XP12B) in Women With Heavy Menstrual Bleeding

A Phase 3 study of Menorrhagia, sponsored by Ferring Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
288
Enrollment target
20
Study locations

NCT01280981 is a Phase 3 study of Menorrhagia that has completed, run by Ferring Pharmaceuticals. The registered enrollment target is 288 participants, above the 200-participant average among 10 other Menorrhagia trials with a reported enrollment target (44% higher). The trial reports 20 study locations across 6 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01280981, a Phase 3 study of Menorrhagia, has completed, sponsored by Ferring Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
288 participants
Enrollment target
20
Study locations

Study Summary

This was a multicenter, open-label extension study for subjects completing either of 2 pivotal efficacy studies (NCT00401193 or NCT00386308). The study consisted of a treatment phase of 9 menstrual periods to assess the safety of tranexamic acid at an oral dose of 1.3 g administered 3 times per day for up to 5 days (maximum of 15 doses) during menstruation. After the last treatment period, a follow-up phone call occurred approximately 30 days (range 25 to 35 days) after the last dose of study drug.

Conditions Studied

Menorrhagia

Interventions

  • DRUG Tranexamic acid

Study Locations (20)

Arizona

  • Women's Health Research - Phoenix
  • Genova Clinical Research - Tucson
  • Quality of Life Medical and Research Center - Tucson
  • Radiant Research - Tucson
  • Visions Clinical Research - Tucson

California

  • Northern California Research Corp - Carmichael
  • Physicians' Research Options, LC - Lakewood
  • Sklar Center for Women's Wellness - Los Alamitos
  • Medical Center for Clinical Research - San Diego
  • INC Clinical Trials - Upland

Florida

  • Nature Coast Clinical Research - Crystal River
  • University of Florida - Gainesville
  • Jacksonville Center for Clinical Research - Jacksonville
  • New Age Medical Research Corp - Miami
  • University of Miami Cedars Medical Center - Miami

Arkansas

  • Lynn Institute of the Ozarks - Little Rock
  • Searcy Medical Center - Searcy

Colorado

  • Advanced Women's Health Institute - Denver
  • Downtown Women's Health Care - Denver

Alabama

  • Radiant Research - Birmingham

Trial Details

FieldValue
Enrollment Target 288 participants
Start Date 2007-04
Est. Completion 2009-05
Phase Phase 3

Sponsor

Ferring Pharmaceuticals

83 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01280981

The ClinicalTrials.gov registry entry for NCT01280981 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 288 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 200-participant average among 10 other Menorrhagia trials with a reported enrollment target (44% higher). The listed sponsor is Ferring Pharmaceuticals, which has 83 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Menorrhagia appearing as the primary indexed condition, and to 1 intervention - of which Tranexamic acid is the first listed.

NCT01280981 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Arizona, California, Florida.

Frequently Asked Questions

What is clinical trial NCT01280981 about?

NCT01280981 is a clinical study titled "A Study of Tranexamic Acid (XP12B) in Women With Heavy Menstrual Bleeding". This was a multicenter, open-label extension study for subjects completing either of 2 pivotal efficacy studies (NCT00401193 or NCT00386308). The study consisted of a treatment phase of 9 menstrual periods to assess the safety of tranexamic acid at an oral dose of 1.3 g administered 3 times per day ...

What is the current status of trial NCT01280981?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 288 participants. The study started on 2007-04. Estimated completion is 2009-05.

What conditions does trial NCT01280981 study?

This clinical trial studies the following conditions: Menorrhagia.

What interventions are being tested in trial NCT01280981?

The interventions under investigation include: Tranexamic acid (DRUG).

Who is sponsoring clinical trial NCT01280981?

This trial is sponsored by Ferring Pharmaceuticals, which has 83 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01280981 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Menorrhagia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Menorrhagia

All registered trials for this condition

Alabama

All trials with a study site in Alabama

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.