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MenorrhagiaPhase 3NCT01280981

A Study of Tranexamic Acid (XP12B) in Women With Heavy Menstrual Bleeding

A Phase 3 study testing Tranexamic acid in people with Menorrhagia, run by Ferring Pharmaceuticals at 92 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 49 years, women only
Conditions the study is for
Menorrhagia
What is being tested?
Tranexamic acid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
288 participants
Where
92 sitesUnited States
Study dates
Apr 2007to May 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 23Show fewer
  • 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.
  • History or presence of hypersensitivity or idiosyncratic reaction to antifibrinolytics (tranexamic acid or aminocaproic acid).
  • Use of any investigational drug except XP12B-MR during the current study.
  • Presence of untreated malabsorption disorder or malnutrition including, but not limited to, chronic diarrhea, celiac disease, short bowl syndrome, Whipple's disease or history of gastric bypass procedure.
  • Presence of defective color vision as determined by the optometrist or ophthalmologist. Inability of the subject to correctly identify symbols on plate 7 of the HRR eye test is not considered defective color vision provided the subject correctly identifies the symbols on plates 11-20.
  • History or presence of glaucoma, ocular hypertension, macular degeneration or retinopathies.
  • History or presence of alcoholism or drug abuse within the past year.
  • Malignancy, or treatment for malignancy, within the previous 2 years, with the exception of basal cell carcinomas of the skin or squamous cell carcinoma of the skin.
  • Does not read or understand English.

Trial locations and contacts

92 sites in 1 country.

92 sites in 1 country

United States92 sites

  • Abington Reproductive Medicine, PC

    Abington, Pennsylvania

  • ClinSite, LLC

    Ann Arbor, Michigan

  • The Gynecology Center

    Baltimore, Maryland

  • Quest Research Institute

    Bingham Farms, Michigan

  • Radiant Research

    Birmingham, Alabama

  • Mid Dakota Clinic

    Bismarck, North Dakota

  • Provident Clinical Research

    Bloomington, Indiana

  • The Women's Clinic

    Boise, Idaho

  • Seasons

    Bristol, Tennessee

  • FAHC, Womens Health Research

    Burlington, Vermont

  • Northern California Research Corp

    Carmichael, California

  • Triphase Research Ltd

    Centerville, Ohio

  • Southeastern Clinical Research

    Chattanooga, Tennessee

  • Alpha Clinical Research, LLC

    Clarksville, Tennessee

  • Rapid Medical Research, Inc

    Cleveland, Ohio

  • University Suburban Health Center

    Cleveland, Ohio

  • J&S Studies, Inc

    College Station, Texas

  • SC Clinical Research Center

    Columbia, South Carolina

  • Nature Coast Clinical Research

    Crystal River, Florida

  • OB/GYN Infertility & Preventive Medicine

    Dallas, Texas

  • Medical Network for Education & Research, Inc.

    Decatur, Georgia

  • Advanced Women's Health Institute

    Denver, Colorado

  • Downtown Women's Health Care

    Denver, Colorado

  • Duke Fertility Center

    Durham, North Carolina

  • Women's Wellness Center

    Durham, North Carolina

  • Clinical Trials of America

    Eugene, Oregon

  • University of Florida

    Gainesville, Florida

  • Holzer Clinic

    Gallipolis, Ohio

  • Grand Valley Gynecologists PC

    Grand Rapids, Michigan

  • Greenville Hospital System-Univ Med Group Dept

    Greenville, South Carolina

  • Greenville Pharmaceutical Research

    Greenville, South Carolina

  • Radiant Research

    Greer, South Carolina

  • Rosemark Womencare Specialists

    Idaho Falls, Idaho

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida

  • The Clinical Trial Center

    Jenkintown, Pennsylvania

  • Center for Pharmaceutical Research

    Kansas City, Missouri

  • Volunteer Research Group

    Knoxville, Tennessee

  • Physicians' Research Options, LC

    Lakewood, California

  • Office of R Garn Mabey, MD

    Las Vegas, Nevada

  • Women's Health Research Center, LLC

    Lawrenceville, New Jersey

  • Family Medical Associates Research Dept

    Levittown, Pennsylvania

  • Lynn Institute of the Ozarks

    Little Rock, Arkansas

  • Sklar Center for Women's Wellness

    Los Alamitos, California

  • York Clinical Consulting

    Marrero, Louisiana

  • PMG/OB-GYN Health Center

    Medford, Oregon

  • Research Memphis Associates

    Memphis, Tennessee

  • Medical Associates Health Centers

    Menomonee Falls, Wisconsin

  • New Age Medical Research Corp

    Miami, Florida

  • University of Miami Cedars Medical Center

    Miami, Florida

  • Montana Medical Research, Inc

    Missoula, Montana

  • Phoenix OB-GYN Assoc, LLC

    Moorestown, New Jersey

  • Tennessee Women's Care, PC

    Nashville, Tennessee

  • Advanced Research Institute

    New Port Richey, Florida

  • American Clinical Trials

    New York, New York

  • Wichita Clinic, P.A.

    Newton, Kansas

  • LION Research

    Norman, Oklahoma

  • Segal Institute for Clinical Research

    North Miami, Florida

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma

  • Radiant Research

    Overland Park, Kansas

  • Women's Health Care Specialist

    Paw Paw, Michigan

  • Philadelphia Clinical Research, LLC

    Philadelphia, Pennsylvania

  • University of Pennsylvania, Dept. OB/GYN

    Philadelphia, Pennsylvania

  • Women's Health Research

    Phoenix, Arizona

  • Valley Forge OB/GYN

    Phoenixville, Pennsylvania

  • Phyllis Gee, MD

    Plano, Texas

  • Mt. Timpanogos Women's Health Center

    Pleasant Grove, Utah

  • The Portland Clinic

    Portland, Oregon

  • Research Across America

    Reading, Pennsylvania

  • Valley Women's Clinic

    Renton, Washington

  • Clinical Trials of Virginia, INC

    Richmond, Virginia

  • KMED Research

    Saint Clair Shores, Michigan

  • Jean Brown Research

    Salt Lake City, Utah

  • Medical Center for Clinical Research

    San Diego, California

  • Physician's Research Options

    Sandy City, Utah

  • The Women's Center of Western Nebraska

    Scottsbluff, Nebraska

  • Searcy Medical Center

    Searcy, Arkansas

  • North Spokane Women's Center

    Spokane, Washington

  • Main Line OB/GYN

    Strafford, Pennsylvania

  • King's Daughters Clinic

    Temple, Texas

  • Women's Healthcare

    The Woodlands, Texas

  • Genova Clinical Research

    Tucson, Arizona

  • Quality of Life Medical and Research Center

    Tucson, Arizona

  • Radiant Research

    Tucson, Arizona

  • Visions Clinical Research

    Tucson, Arizona

  • INC Clinical Trials

    Upland, California

  • Tidewater Clinical Research, Inc.

    Virginia Beach, Virginia

  • Center of Reproductive Medicine

    Webster, Texas

  • Granger Medical OB/GYN

    West Valley City, Utah

  • Wexford Professional Bldg II

    Wexford, Pennsylvania

  • Lyndhurst Gynecologic Associates

    Winston-Salem, North Carolina

  • Piedmont Medical Research Associates

    Winston-Salem, North Carolina

  • Physicians Research, Inc.

    Zanesville, Ohio

Other trials in United States

About this study

Official title: 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

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.

Conditions
Menorrhagia
Being tested
Tranexamic acid
Keywords
Menorrhagia, Heavy Menstrual Bleeding, Lysteda
Medical subject headings
Menorrhagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tranexamic acidDrug

    Also called XP12B, Lysteda

    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.

Study groups in NCT01280981
Study groupRoleWhat they receive
Tranexamic acidExperimentalTwo 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).
Receives: Drug: Tranexamic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 1 to up to Month 9

Secondary outcomes (5)

  1. Participants With Abnormal Gynecological Examinations

    Participants with abnormal gynecological examination findings based on endometrial biopsies and transvaginal ultraonogrphy (TVU) are summarized. Clinically significant results from the endometrial biopsies are results that are not benign. Abnormalities found during transvaginal ultrasonography (TVU) are detailed in the AE listings. Please refer to AE listings.

    Measured: Day 1 to up to Month 9

  2. Mean Blood Pressure Measurements at Week 36

    Mean systolic and diastolic blood pressure measurements taken at week 36

    Measured: approximately week 36

  3. Participants With Treatment Emergent Adverse Experiences (TEAE) of Laboratory Values Related to Treatment

    Participants whose laboratory examinations (hematology, blood chemistry and urinalysis) were considered by the investigator to be treatment emergent adverse experiences (TEAE) and related to treatment. Also indicated is whether the TEAE lab parameter caused the participant to discontinue from the study.

    Measured: Day 1 to up to Month 9

  4. Mean Intraocular Pressure at Month 9

    Mean intraocular pressure at month 9 or the early termination visit.

    Measured: Day 1 up to Month 9

  5. Mean Fridericia-corrected QT Interval (QTcFRI) at Month 9

    The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization

    Measured: Month 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2011 (estimated)
  2. Study startApr 2007
  3. Primary completionMay 2009
  4. Study completionMay 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
288 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01280981
Sponsor's protocol ID
XP12B-MR-304
Status last verified
Jun 2011
First submitted
19 Jan 2011
Last updated
26 Jul 2011
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tranexamic acid in people with Menorrhagia, run by Ferring Pharmaceuticals at 92 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants With Treatment-Emergent Adverse Events (AEs) (time frame: Day 1 to up to Month 9). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01280981.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2011.

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