A Study of Tranexamic Acid (XP12B) in Women With Heavy Menstrual Bleeding
A Multi-center, Open Label Extension Study to Evaluate the Safety of an Oral Dose of Tranexamic Acid (XP12B) Administered Three Times Daily During Menstruation for the Treatment of Menorrhagia
1 other identifier
interventional
288
1 country
92
Brief Summary
This was a multicenter, open-label extension study for subjects completing either of 2 pivotal efficacy studies (NCT00401193 or NCT00386308). The study consisted of a treatment phase of 9 menstrual periods to assess the safety of tranexamic acid at an oral dose of 1.3 g administered 3 times per day for up to 5 days (maximum of 15 doses) during menstruation. After the last treatment period, a follow-up phone call occurred approximately 30 days (range 25 to 35 days) after the last dose of study drug.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2007
92 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 19, 2011
CompletedFirst Posted
Study publicly available on registry
January 21, 2011
CompletedResults Posted
Study results publicly available
July 26, 2011
CompletedJuly 26, 2011
June 1, 2011
2.1 years
January 19, 2011
May 3, 2011
June 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Participants With Treatment-Emergent Adverse Events (AEs)
Count of participants with treatment-emergent adverse events grouped in categories regarding relationship to study drug as assessed by the investigator, serious or life-threatening as assessed by the investigator, participants who died or their event led to withdrawal from study, and participants who experienced thrombotic or thromboembolic AEs.
Day 1 to up to Month 9
Secondary Outcomes (5)
Participants With Abnormal Gynecological Examinations
Day 1 to up to Month 9
Mean Blood Pressure Measurements at Week 36
approximately week 36
Participants With Treatment Emergent Adverse Experiences (TEAE) of Laboratory Values Related to Treatment
Day 1 to up to Month 9
Mean Intraocular Pressure at Month 9
Day 1 up to Month 9
Mean Fridericia-corrected QT Interval (QTcFRI) at Month 9
Month 9
Study Arms (1)
Tranexamic acid
EXPERIMENTALTwo 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
Interventions
Tranexamic acid at an oral dose of 1.3 g administered 3 times per day for up to 5 days (maximum of 15 doses) during menstruation for 9 menstrual periods.
Eligibility Criteria
You may qualify if:
- The study enrolled subjects who had completed the double-blind therapy in either the XP12B-MR-301 or XP12B-MR-303 study, including scheduled evaluations, with no major protocol violations and no study events that, in the opinion of the investigator, would preclude the subject's entry into the open-label safety study.
- A negative urine pregnancy test was required immediately before entry into this study.
- Women must have been surgically sterile or, if of childbearing potential, must have been in a monogamous relationship with a sterile partner or a partner of the same sex.
- Women must have used an acceptable barrier contraception method with spermicide for the duration of the study or must have been using a copper intrauterine device (IUD).
- In the opinion of the investigator, the subject must be able to understand this study, cooperate with all study procedures, be able to return to the study site for visits within the required visit windows and be deemed likely to complete the study.
- Subject will provide voluntary, written consent to participate in the study by signing and dating an institutional review board (IRB)-approved informed consent before any procedures are performed or study drug is dispensed.
You may not qualify if:
- History or presence of clinically significant hepatic or renal disease or other medical disease that might confound the study or be detrimental to the subject (e.g., clinically significant cardiac arrhythmia, uncontrolled diabetes or uncontrolled hypertension) as determined by the investigator.
- Normal gynecological examination and breast examination.
- Clinically significant abnormalities on screening physical examination that might confound the study or be detrimental to the subject as assessed by the investigator. Abnormal clinically significant electrocardiograms (ECG) as determined by the centralized cardiologist, or laboratory tests suggestive of a potential pituitary-prolactin stimulating tumor (prolactin \>=30 µg/L), thrombocytopenia (platelet count \<100,000/mm3), uncontrolled hypothyroidism (TSH \>=10 mU/L) or severe anemia (hemoglobin \<8 g/dL\]).
- Anovulatory dysfunctional uterine bleeding, metrorrhagia (irregular or frequent noncyclic flow), menometrorrhagia (irregular or frequent excessive noncyclic flow) or polymenorrhea (frequent flow, cycles of less than 21 days).
- History or presence of endometrial polyps, endometrial hyperplasia, endometrial carcinoma or cervical carcinoma (includes cervical carcinoma in situ).
- History of bilateral oophorectomy or hysterectomy.
- Women who are pregnant, breastfeeding, planning to become pregnant during the study or become pregnant during the study.
- History or active presence of myocardial infarction or ischemic disease. History or active presence of cerebrovascular accident, stroke, or transient ischemic attack.
- History or presence of thrombosis, thromboembolic disease or coagulopathy including, but not limited to, pulmonary embolism, deep venous thrombosis, phlebitis and any intravascular clotting disorder.
- History or known presence of acquired or inherited thrombophilia, including, but not limited to, antithrombin deficiency, Protein C and/or S deficiency, antiphospholipid deficiency, Factor V Leiden mutation and prothrombin mutation. Thalassemia or sickle cell disease (sickle cell trait individuals are not excluded).
- History or presence of subarachnoid hemorrhage.
- Use or anticipated use of medications taken to relieve β-Hydroxy β-methylbutyric acid (HMB) including the use of vaginal \[rings, creams, gels\] and transdermal hormone products; use of oral estrogen-, progestin- or SERM-containing drug products, or intrauterine progestins containing drug products. Use or anticipated use of Lupron (1 or 3 month) depot injection or estrogen pellet or long-acting progestin injectables.
- Use or anticipated use of meclofenamate sodium, mefenamic acid, danazol, or desmopressin acetate or herbal remedies. Herbal remedies include, but are not limited to, Capsella bursa pastoris (i.e. Sheperd's Purse), Agnus castus (i.e. Chasteberry, Vitex), Cimicifuga racemosa (i.e. Black Cohosh), Symphytum officionale (i.e. Comfrey), and/or Angelica sinensis (i.e. Dong Quai).
- Use of or anticipated use of the following drugs: oral, transdermal, injectable and vaginal ring (NuvaRing®) hormonal contraceptives; anticoagulants (warfarin \[Coumadin®\], heparin, low-molecular-weight heparin (LMWH), etc.), aminocaproic acid (Amicar®) or Plaquenil®.
- Current use of an intrauterine device (IUD) other than copper IUDs.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ferring Pharmaceuticalslead
- Xanodyne Pharmaceuticalscollaborator
Study Sites (92)
Radiant Research
Birmingham, Alabama, United States
Women's Health Research
Phoenix, Arizona, United States
Genova Clinical Research
Tucson, Arizona, United States
Quality of Life Medical and Research Center
Tucson, Arizona, United States
Radiant Research
Tucson, Arizona, United States
Visions Clinical Research
Tucson, Arizona, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States
Searcy Medical Center
Searcy, Arkansas, United States
Northern California Research Corp
Carmichael, California, United States
Physicians' Research Options, LC
Lakewood, California, United States
Sklar Center for Women's Wellness
Los Alamitos, California, United States
Medical Center for Clinical Research
San Diego, California, United States
INC Clinical Trials
Upland, California, United States
Advanced Women's Health Institute
Denver, Colorado, United States
Downtown Women's Health Care
Denver, Colorado, United States
Nature Coast Clinical Research
Crystal River, Florida, United States
University of Florida
Gainesville, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
New Age Medical Research Corp
Miami, Florida, United States
University of Miami Cedars Medical Center
Miami, Florida, United States
Advanced Research Institute
New Port Richey, Florida, United States
Segal Institute for Clinical Research
North Miami, Florida, United States
Medical Network for Education & Research, Inc.
Decatur, Georgia, United States
The Women's Clinic
Boise, Idaho, United States
Rosemark Womencare Specialists
Idaho Falls, Idaho, United States
Provident Clinical Research
Bloomington, Indiana, United States
Wichita Clinic, P.A.
Newton, Kansas, United States
Radiant Research
Overland Park, Kansas, United States
York Clinical Consulting
Marrero, Louisiana, United States
The Gynecology Center
Baltimore, Maryland, United States
ClinSite, LLC
Ann Arbor, Michigan, United States
Quest Research Institute
Bingham Farms, Michigan, United States
Grand Valley Gynecologists PC
Grand Rapids, Michigan, United States
Women's Health Care Specialist
Paw Paw, Michigan, United States
KMED Research
Saint Clair Shores, Michigan, United States
Center for Pharmaceutical Research
Kansas City, Missouri, United States
Montana Medical Research, Inc
Missoula, Montana, United States
The Women's Center of Western Nebraska
Scottsbluff, Nebraska, United States
Office of R Garn Mabey, MD
Las Vegas, Nevada, United States
Women's Health Research Center, LLC
Lawrenceville, New Jersey, United States
Phoenix OB-GYN Assoc, LLC
Moorestown, New Jersey, United States
American Clinical Trials
New York, New York, United States
Duke Fertility Center
Durham, North Carolina, United States
Women's Wellness Center
Durham, North Carolina, United States
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, United States
Piedmont Medical Research Associates
Winston-Salem, North Carolina, United States
Mid Dakota Clinic
Bismarck, North Dakota, United States
Triphase Research Ltd
Centerville, Ohio, United States
Rapid Medical Research, Inc
Cleveland, Ohio, United States
University Suburban Health Center
Cleveland, Ohio, United States
Holzer Clinic
Gallipolis, Ohio, United States
Physicians Research, Inc.
Zanesville, Ohio, United States
LION Research
Norman, Oklahoma, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Clinical Trials of America
Eugene, Oregon, United States
PMG/OB-GYN Health Center
Medford, Oregon, United States
The Portland Clinic
Portland, Oregon, United States
Abington Reproductive Medicine, PC
Abington, Pennsylvania, United States
The Clinical Trial Center
Jenkintown, Pennsylvania, United States
Family Medical Associates Research Dept
Levittown, Pennsylvania, United States
Philadelphia Clinical Research, LLC
Philadelphia, Pennsylvania, United States
University of Pennsylvania, Dept. OB/GYN
Philadelphia, Pennsylvania, United States
Valley Forge OB/GYN
Phoenixville, Pennsylvania, United States
Research Across America
Reading, Pennsylvania, United States
Main Line OB/GYN
Strafford, Pennsylvania, United States
Wexford Professional Bldg II
Wexford, Pennsylvania, United States
SC Clinical Research Center
Columbia, South Carolina, United States
Greenville Hospital System-Univ Med Group Dept
Greenville, South Carolina, United States
Greenville Pharmaceutical Research
Greenville, South Carolina, United States
Radiant Research
Greer, South Carolina, United States
Seasons
Bristol, Tennessee, United States
Southeastern Clinical Research
Chattanooga, Tennessee, United States
Alpha Clinical Research, LLC
Clarksville, Tennessee, United States
Volunteer Research Group
Knoxville, Tennessee, United States
Research Memphis Associates
Memphis, Tennessee, United States
Tennessee Women's Care, PC
Nashville, Tennessee, United States
J&S Studies, Inc
College Station, Texas, United States
OB/GYN Infertility & Preventive Medicine
Dallas, Texas, United States
Phyllis Gee, MD
Plano, Texas, United States
King's Daughters Clinic
Temple, Texas, United States
Women's Healthcare
The Woodlands, Texas, United States
Center of Reproductive Medicine
Webster, Texas, United States
Mt. Timpanogos Women's Health Center
Pleasant Grove, Utah, United States
Jean Brown Research
Salt Lake City, Utah, United States
Physician's Research Options
Sandy City, Utah, United States
Granger Medical OB/GYN
West Valley City, Utah, United States
FAHC, Womens Health Research
Burlington, Vermont, United States
Clinical Trials of Virginia, INC
Richmond, Virginia, United States
Tidewater Clinical Research, Inc.
Virginia Beach, Virginia, United States
Valley Women's Clinic
Renton, Washington, United States
North Spokane Women's Center
Spokane, Washington, United States
Medical Associates Health Centers
Menomonee Falls, Wisconsin, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Development Support
- Organization
- Ferring Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
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
January 19, 2011
First Posted
January 21, 2011
Study Start
April 1, 2007
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
July 26, 2011
Results First Posted
July 26, 2011
Record last verified: 2011-06