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

COMPLETED Phase 3

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

NCT01280981 · View on ClinicalTrials.gov ↗

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

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

27 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 288 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ferring Pharmaceuticals, which has 27 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01280981 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Arizona, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01280981?

The interventions under investigation include: Tranexamic acid (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01280981?

This trial is sponsored by Ferring Pharmaceuticals, which has 27 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial