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Completed

NCT Number: NCT00386308

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.

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Key information

Conditions

Menorrhagia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Heavy Menstrual Bleeding Hemorrhage Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Investigative Site, Tucson, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women with menorrhagia
  • 18-49 years of age
  • Regularly occurring menstrual periods

Exclusion criteria

  • History or presence of clinically significant disease or abnormalities that may confound the study
  • History of bilateral oophorectomy or hysterectomy
  • Hormone therapy

Treatment and study plan

Tranexamic acid tablets

Drug

3900 mg/Day

Other names: Lysteda, XP12B

Placebo tablets

Drug

Other names: Lysteda, XP12B

Primary outcomes

  1. Mean Reduction From Baseline in Menstrual Blood Loss (MBL)

    Time frame: Baseline MBL over 6 menstrual cycles

    reduction of menstrual blood loss in mL

Secondary outcomes

  1. Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding

    Time frame: Change from Baseline scores over 6 menstrual cycles

    A positive unit change mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited

  2. Patient Reported Outcome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding

    Time frame: Change from Baseline scores over 6 menstrual cycles

    A positive unit change mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited

  3. Responder Analysis - Reduction in Large Stains

    Time frame: Reduction from Baseline over 6 menstrual cycles

    Percentage of subjects who experienced a reduction from baseline in the frequency of large stains

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study To Evaluate Efficacy and Safety of XP12B for the Treatment of Menorrhagia

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Oct 11, 2006
Registry last updated
May 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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