Safety Study of XP12B in Women With Menorrhagia

Menorrhagia Clinical Trial

Official title:

Multicenter Study to Evaluate the Safety of XP12B in Women With Heavy Menstrual Bleeding Associated With Menorrhagia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00113568
• Other study ID #: XP12B-MR-302
• Status: Completed
• Phase: Phase 3
• First received: June 8, 2005
• Last updated: June 9, 2010
• Start date: June 2005
• Est. completion date: May 2009

Study information

• Verified date: June 2010
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 784
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• Women with menorrhagia

• 18-49 years of age

• Regularly occuring menstrual periods

Exclusion Criteria:

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

• History of bilateral oophorectomy or hysterectomy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heavy Menstrual Bleeding
• Hemorrhage
• Menorrhagia

Intervention

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

Locations

Country	Name	City	State
United States	Investigative Site	Albuquerque	New Mexico
United States	Investigative Site	Alpharetta	Georgia
United States	Investigative Site	Billings	Montana
United States	Investigative Site	Birmingham	Alabama
United States	Investigative Site	Boise	Idaho
United States	Investigative Site	Champaign	Illinois
United States	Investigative Site	Charlotte	North Carolina
United States	Investigative Site	Chaska	Minnesota
United States	Investigative Site	Cincinnati	Ohio
United States	Investigative Site	Cincinnati	Ohio
United States	Investigative Site	Colorado Springs	Colorado
United States	Investigative Site	Columbia	South Carolina
United States	Investigative Site	Denver	Colorado
United States	Investigative Site	Durham	North Carolina
United States	Investigative Site	Evansville	Indiana
United States	Investigative Site	Ft. Myers	Florida
United States	Investigative Site	Houston	Texas
United States	Investigative Site	Indianapolis	Indiana
United States	Investigative Site	Johnson City	New York
United States	Investigative Site	Jonesboro	Arkansas
United States	Investigative Site	Las Vegas	Nevada
United States	Investigative Site	Las Vegas	Nevada
United States	Investigative Site	Lexington	Kentucky
United States	Investigative Site	Little Rock	Arkansas
United States	Investigative Site	Louisville	Kentucky
United States	Investigative Site	Miami	Florida
United States	Investigative Site	Mobile	Alabama
United States	Investigative Site	Montgomery	Alabama
United States	Investigative Site	Moorestown	New Jersey
United States	Investigative Site	Nashville	Tennessee
United States	Investigative Site	Nashville	Tennessee
United States	Investigative Site	New Port Richey	Florida
United States	Investigative Site	Norfolk	Virginia
United States	Investigative Site	Ocala	Florida
United States	Investigative Site	Omaha	Nebraska
United States	Investigative Site	Overland Park	Kansas
United States	Investigative Site	Philadelphia	Pennsylvania
United States	Investigative Site	Phoenix	Arizona
United States	Investigative Site	Phoenix	Arizona
United States	Investigative Site	Pinellas Park	Florida
United States	Investigative Site	Portage	Michigan
United States	Investigative Site	Roswell	Georgia
United States	Investigative Site	San Diego	California
United States	Investigative Site	San Diego	California
United States	Investigative Site	Savannah	Georgia
United States	Investigative Site	Savannah	Georgia
United States	Investigative Site	Seattle	Washington
United States	Investigative Site	Shreveport	Louisiana
United States	Investigative Site	South Bend	Indiana
United States	Investigative Site	St. Louis	Missouri
United States	Investigative Site	St. Louis	Missouri
United States	Investigative Site	St. Louis	Missouri
United States	Investigative Site	Tacoma	Washington
United States	Investigative Site	Toledo	Ohio
United States	Investigative Site	Venice	Florida
United States	Investigative Site	West Palm Beach	Florida
United States	Investigative Site	West Palm Beach	Florida
United States	Investigative Site	Wexford	Pennsylvania
United States	Investigative Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	Number of Subjects Who Died During the Study	Number of subjects who died, for any reason, during the study	Up to 27 menstrual cycles	Yes