Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00113568
Other study ID # XP12B-MR-302
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT02824224 - Tamoxifen to Reduce Unscheduled Bleeding in New Users of the Levonorgestrel-releasing Intrauterine System (LNG-IUS) Phase 4
Withdrawn NCT01651468 - The Effect of the Nutraceutical "Hemofix" on the Coagulation System N/A
Recruiting NCT02616731 - Oral Tranexamic Acid Versus Diosmin for Treatment of Menorrhagia in Women Using Copper IUD Phase 1/Phase 2
Terminated NCT02087228 - Evaluation of the Endometrial Cavity After Endometrial Ablation N/A
Withdrawn NCT00953641 - Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy Phase 3
Completed NCT01436903 - Chances for Success of CavatermTM Surgery as a Function of Uterus Probe Length Phase 4
Withdrawn NCT00768742 - Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study N/A
Completed NCT00152256 - A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids Phase 3
Completed NCT00156195 - Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids Phase 3
Completed NCT00160381 - A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids Phase 3
Completed NCT02228174 - Sonography Guided Transcervical Ablation of Uterine Fibroids N/A
Terminated NCT01969396 - Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology N/A
Completed NCT00386308 - Efficacy and Safety Study of XP12B in Women With Menorrhagia Phase 3
Completed NCT00393198 - Bleeding Pattern and User Satisfaction During Second Consecutive MIRENA® in Contraception and Treatment of Menorrhagia Phase 4
Completed NCT00966264 - Hysterectomy and Levonorgestrel Releasing Intrauterine System (LNG-IUS) in the Treatment of Menorrhagia Phase 3
Completed NCT00904709 - The Assessment of Tranexamic Acid in Women With Menorrhagia Who Have Bleeding Disorders Phase 4
Recruiting NCT03670680 - Efficiency of Lina LibrataTM System N/A
Completed NCT02584088 - Ultrasound Appearance of the Endometrium Post Radio-Frequency Ablation
Completed NCT02835391 - PerClot Compared to Usual Care in Gynaecology Procedures N/A
Completed NCT02304510 - Prevalence of Heavy Menstrual Bleeding in Female Population Living in Beijing