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COMPLETED Phase 3

Efficacy and Safety Study of XP12B in Women With Menorrhagia

NCT00386308 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to determine whether XP12B is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia.

Interventions

  • DRUG Tranexamic acid tablets
  • DRUG Placebo tablets

Study Locations (20)

Georgia

  • Investigative Site — Atlanta
  • Investigative Site — Atlanta
  • Investigative Site — Decatur
  • Investigative Site — Savannah

California

  • Investigative Site — Carmichael
  • Investigative Site — San Diego
  • Investigative Site — Upland

Florida

  • Investigative Site — Inverness
  • Investigative Site — Miami
  • Investigative Site — Miami

Arizona

  • Investigative Site — Tucson
  • Investigative Site — Tucson

Colorado

  • Investigative Site — Denver
  • Investigative Site — Lakewood

Connecticut

  • Investigative Site — Groton
  • Investigative Site — West Hartford

Louisiana

  • Investigative Site — Amite
  • Investigative Site — Baton Rouge

Arkansas

  • Investigative Site — Little Rock

Trial Details

FieldValue
Enrollment Target 196 participants
Start Date 2006-10
Est. Completion 2008-05
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 NCT00386308

The ClinicalTrials.gov registry entry for NCT00386308 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 196 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 2 conditions, with Menorrhagia appearing as the primary indexed condition, and to 2 interventions — of which Tranexamic acid tablets 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: NCT00386308 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Georgia, 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 NCT00386308 about?

NCT00386308 is a clinical study titled "Efficacy and Safety Study of XP12B in Women With Menorrhagia". The purpose of this study is to determine whether XP12B is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia.

What is the current status of trial NCT00386308?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 196 participants. The study started on 2006-10. Estimated completion is 2008-05.

What conditions does trial NCT00386308 study?

This clinical trial studies the following conditions: Menorrhagia, Heavy Menstrual Bleeding. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00386308?

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

Who is sponsoring clinical trial NCT00386308?

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 NCT00386308 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. 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