Safety Study of XP12B in Women With Menorrhagia

NCT00113568 | Completed Phase 3 Results DMC

• 1 other identifier: XP12B-MR-302
• Study Type: interventional
• Target: 784
• Locations: 1 country
• Sites: 59

Brief Summary

The purpose of this study is to evaluate the safety of XP12B in women with heavy menstrual bleeding associated with menorrhagia.

Conditions

Menorrhagia; Heavy Menstrual Bleeding

Keywords

Menorrhagia; Heavy Menstrual Bleeding

Outcome Measures

Primary Outcomes (9)

• Number of Subjects With at Least One Adverse Event During the Study

  An adverse event is any untoward, undesired, unplanned clinical event in the form of signs. symptoms, disease, or laboratory or physiological observations occurring in a human being participating in a clinical study with a sponsor study drug, regardless of causal relationship.

  Up to 27 menstrual cycles

• Number of Subjects With at Least One Possibly Treatment-Related Adverse Event During the Study

  The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A possibly treatment-related adverse event is an event that may be explained by administration of the study drug or by the subjects's clinical state or other agents/therapies.

  Up to 27 menstrual cycles

• Number of Subjects With at Least One Probably Treatment-Related Adverse Event During the Study

  The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A probably treatment-related adverse event is an event most likely to be explained by administration of the study drug rather than the subjects's clinical state or other agents/therapies.

  Up to 27 menstrual cycles

• Number of Subjects With at Least One Definitely Treatment-Related Adverse Event During the Study

  The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A definitely treatment-related adverse event is an event that can be fully explained by administration of the study drug.

  Up to 27 menstrual cycles

• Number of Subjects With at Least One Serious Adverse Event During the Study

  A serious adverse event (SAE) is any adverse event (AE) occurring at any dose that meets 1 or more of the following criteria: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in a persistent or significant disability or incapacity; results in cancer; results in a congenital anomaly or birth defect. Important medical events not described above may be considered SAEs when based on appropriate medical judgment.

  Up to 27 menstrual cycles

• Number of Subjects With at Least One Life-Threatening Adverse Event During the Study

  A life-threatening AE is any AE that places the subject at immediate risk of death from the event as it occurred.

  Up to 27 menstrual cycles

• Number of Subjects With Adverse Events That Led to Discontinuation From the Study

  The total number of subjects who withdrew from the study due to an adverse event irrespective of the causal relation between the AE and the study drug as determined by the investigator

  Up to 27 menstrual cycles

• Number of Subjects With Any Thrombotic or Thromboembolic Adverse Event During the Study

  Examples include deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, central retinal artery and vein obstruction.

  Up to 27 menstrual cycles

• Number of Subjects Who Died During the Study

  Number of subjects who died, for any reason, during the study

  Up to 27 menstrual cycles

Study Arms (1)

XP12B (tranexamic acid tablets)

EXPERIMENTAL

Drug: Tranexamic acid tablets (XP12B)

Interventions

Tranexamic acid tablets (XP12B) DRUG

Two 650 mg tranexamic acid tablets (XP12B) taken 3 times daily (3900 mg/Day) for a maximum of 5 days during monthly menstruation

Also known as: Lysteda, XP12B, tranexamic acid tablets, XP12B-MR

XP12B (tranexamic acid tablets)

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with menorrhagia
• years of age
• Regularly occuring menstrual periods

You may not qualify if:

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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (59)

Investigative Site

Birmingham, Alabama, 35235, United States

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Mobile, Alabama, 36608, United States

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Montgomery, Alabama, 36106, United States

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Phoenix, Arizona, 85032, United States

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Phoenix, Arizona, 85035, United States

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Jonesboro, Arkansas, 72401, United States

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Little Rock, Arkansas, 72205, United States

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San Diego, California, 92103, United States

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San Diego, California, 92108, United States

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Colorado Springs, Colorado, 80909, United States

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Denver, Colorado, 80202, United States

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Fort Myers, Florida, 33916, United States

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Miami, Florida, 33186, United States

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New Port Richey, Florida, 34652, United States

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Ocala, Florida, 34471, United States

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Pinellas Park, Florida, 33781, United States

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Venice, Florida, 34292, United States

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West Palm Beach, Florida, 33407, United States

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West Palm Beach, Florida, 33409, United States

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Alpharetta, Georgia, 30005, United States

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Roswell, Georgia, 30075, United States

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Savannah, Georgia, 31405, United States

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Savannah, Georgia, 31406, United States

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Boise, Idaho, 83702, United States

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Champaign, Illinois, 61820, United States

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Evansville, Indiana, 47713, United States

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Indianapolis, Indiana, 46250, United States

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South Bend, Indiana, 46601, United States

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Overland Park, Kansas, 66210, United States

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Lexington, Kentucky, 40536, United States

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Louisville, Kentucky, 40291, United States

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Shreveport, Louisiana, 71103, United States

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Portage, Michigan, 49024, United States

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Chaska, Minnesota, 55318, United States

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St Louis, Missouri, 63110, United States

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St Louis, Missouri, 63117, United States

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St Louis, Missouri, 63141, United States

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Billings, Montana, 59102, United States

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Omaha, Nebraska, 68131, United States

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Las Vegas, Nevada, 89030, United States

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Las Vegas, Nevada, 89128, United States

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Moorestown, New Jersey, 08057, United States

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Albuquerque, New Mexico, 87102, United States

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Johnson City, New York, 13790, United States

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Charlotte, North Carolina, 28209, United States

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Durham, North Carolina, 27710, United States

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Winston-Salem, North Carolina, 27103, United States

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Cincinnati, Ohio, 45249, United States

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Cincinnati, Ohio, 45267, United States

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Toledo, Ohio, 43614, United States

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Philadelphia, Pennsylvania, 19104, United States

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Wexford, Pennsylvania, 15090, United States

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Columbia, South Carolina, 29201, United States

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Nashville, Tennessee, 37203, United States

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Nashville, Tennessee, 37208, United States

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Houston, Texas, 77030, United States

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Norfolk, Virginia, 23507, United States

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Seattle, Washington, 98105, United States

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Tacoma, Washington, 98405, United States

Location

Related Publications (2)

• Muse K, Lukes AS, Gersten J, Waldbaum A, Mabey RG, Trott E. Long-term evaluation of safety and health-related quality of life in women with heavy menstrual bleeding treated with oral tranexamic acid. Womens Health (Lond). 2011 Nov;7(6):699-707. doi: 10.2217/whe.11.65. Epub 2011 Aug 25.

  PMID: 21867401 DERIVED

• Bushnell DM, Martin ML, Moore KA, Richter HE, Rubin A, Patrick DL. Menorrhagia Impact Questionnaire: assessing the influence of heavy menstrual bleeding on quality of life. Curr Med Res Opin. 2010 Dec;26(12):2745-55. doi: 10.1185/03007995.2010.532200. Epub 2010 Nov 3.

  PMID: 21043553 DERIVED

MeSH Terms

Conditions

Menorrhagia

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Clinical Development Support
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 8, 2005
• First Posted: June 9, 2005
• Study Start: June 1, 2005
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: June 15, 2010
• Results First Posted: January 20, 2010

Record last verified: 2010-06

Locations

US (59)