A Study of Tranexamic Acid (XP12B) in Women With Heavy Menstrual Bleeding
Public ClinicalTrials.gov record NCT01280981. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01280981
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 288 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 49 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2007 (Type not available)
- Primary completion
- May 2009 (Actual)
- Completion
- May 2009 (Actual)
- Last update posted
- Jul 26, 2011
2007 – 2009
United States locations
- U.S. sites
- 92
- U.S. states
- 33
- U.S. cities
- 82
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Radiant Research | Birmingham | Alabama | — | — |
| Women's Health Research | Phoenix | Arizona | — | — |
| Genova Clinical Research | Tucson | Arizona | — | — |
| Quality of Life Medical and Research Center | Tucson | Arizona | — | — |
| Radiant Research | Tucson | Arizona | — | — |
| Visions Clinical Research | Tucson | Arizona | — | — |
| Lynn Institute of the Ozarks | Little Rock | Arkansas | — | — |
| Searcy Medical Center | Searcy | Arkansas | — | — |
| Northern California Research Corp | Carmichael | California | — | — |
| Physicians' Research Options, LC | Lakewood | California | — | — |
| Sklar Center for Women's Wellness | Los Alamitos | California | — | — |
| Medical Center for Clinical Research | San Diego | California | — | — |
| INC Clinical Trials | Upland | California | — | — |
| Advanced Women's Health Institute | Denver | Colorado | — | — |
| Downtown Women's Health Care | Denver | Colorado | — | — |
| Nature Coast Clinical Research | Crystal River | Florida | — | — |
| University of Florida | Gainesville | Florida | — | — |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | — | — |
| New Age Medical Research Corp | Miami | Florida | — | — |
| University of Miami Cedars Medical Center | Miami | Florida | — | — |
| Advanced Research Institute | New Port Richey | Florida | — | — |
| Segal Institute for Clinical Research | North Miami | Florida | — | — |
| Medical Network for Education & Research, Inc. | Decatur | Georgia | — | — |
| The Women's Clinic | Boise | Idaho | — | — |
| Rosemark Womencare Specialists | Idaho Falls | Idaho | — | — |
| Provident Clinical Research | Bloomington | Indiana | — | — |
| Wichita Clinic, P.A. | Newton | Kansas | — | — |
| Radiant Research | Overland Park | Kansas | — | — |
| York Clinical Consulting | Marrero | Louisiana | — | — |
| The Gynecology Center | Baltimore | Maryland | — | — |
| ClinSite, LLC | Ann Arbor | Michigan | — | — |
| Quest Research Institute | Bingham Farms | Michigan | — | — |
| Grand Valley Gynecologists PC | Grand Rapids | Michigan | — | — |
| Women's Health Care Specialist | Paw Paw | Michigan | — | — |
| KMED Research | Saint Clair Shores | Michigan | — | — |
| Center for Pharmaceutical Research | Kansas City | Missouri | — | — |
| Montana Medical Research, Inc | Missoula | Montana | — | — |
| The Women's Center of Western Nebraska | Scottsbluff | Nebraska | — | — |
| Office of R Garn Mabey, MD | Las Vegas | Nevada | — | — |
| Women's Health Research Center, LLC | Lawrenceville | New Jersey | — | — |
| Phoenix OB-GYN Assoc, LLC | Moorestown | New Jersey | — | — |
| American Clinical Trials | New York | New York | — | — |
| Duke Fertility Center | Durham | North Carolina | — | — |
| Women's Wellness Center | Durham | North Carolina | — | — |
| Lyndhurst Gynecologic Associates | Winston-Salem | North Carolina | — | — |
| Piedmont Medical Research Associates | Winston-Salem | North Carolina | — | — |
| Mid Dakota Clinic | Bismarck | North Dakota | — | — |
| Triphase Research Ltd | Centerville | Ohio | — | — |
| Rapid Medical Research, Inc | Cleveland | Ohio | — | — |
| University Suburban Health Center | Cleveland | Ohio | — | — |
| Holzer Clinic | Gallipolis | Ohio | — | — |
| Physicians Research, Inc. | Zanesville | Ohio | — | — |
| LION Research | Norman | Oklahoma | — | — |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | — | — |
| Clinical Trials of America | Eugene | Oregon | — | — |
| PMG/OB-GYN Health Center | Medford | Oregon | — | — |
| The Portland Clinic | Portland | Oregon | — | — |
| Abington Reproductive Medicine, PC | Abington | Pennsylvania | — | — |
| The Clinical Trial Center | Jenkintown | Pennsylvania | — | — |
| Family Medical Associates Research Dept | Levittown | Pennsylvania | — | — |
| Philadelphia Clinical Research, LLC | Philadelphia | Pennsylvania | — | — |
| University of Pennsylvania, Dept. OB/GYN | Philadelphia | Pennsylvania | — | — |
| Valley Forge OB/GYN | Phoenixville | Pennsylvania | — | — |
| Research Across America | Reading | Pennsylvania | — | — |
| Main Line OB/GYN | Strafford | Pennsylvania | — | — |
| Wexford Professional Bldg II | Wexford | Pennsylvania | — | — |
| SC Clinical Research Center | Columbia | South Carolina | — | — |
| Greenville Hospital System-Univ Med Group Dept | Greenville | South Carolina | — | — |
| Greenville Pharmaceutical Research | Greenville | South Carolina | — | — |
| Radiant Research | Greer | South Carolina | — | — |
| Seasons | Bristol | Tennessee | — | — |
| Southeastern Clinical Research | Chattanooga | Tennessee | — | — |
| Alpha Clinical Research, LLC | Clarksville | Tennessee | — | — |
| Volunteer Research Group | Knoxville | Tennessee | — | — |
| Research Memphis Associates | Memphis | Tennessee | — | — |
| Tennessee Women's Care, PC | Nashville | Tennessee | — | — |
| J&S Studies, Inc | College Station | Texas | — | — |
| OB/GYN Infertility & Preventive Medicine | Dallas | Texas | — | — |
| Phyllis Gee, MD | Plano | Texas | — | — |
| King's Daughters Clinic | Temple | Texas | — | — |
| Women's Healthcare | The Woodlands | Texas | — | — |
| Center of Reproductive Medicine | Webster | Texas | — | — |
| Mt. Timpanogos Women's Health Center | Pleasant Grove | Utah | — | — |
| Jean Brown Research | Salt Lake City | Utah | — | — |
| Physician's Research Options | Sandy City | Utah | — | — |
| Granger Medical OB/GYN | West Valley City | Utah | — | — |
| FAHC, Womens Health Research | Burlington | Vermont | — | — |
| Clinical Trials of Virginia, INC | Richmond | Virginia | — | — |
| Tidewater Clinical Research, Inc. | Virginia Beach | Virginia | — | — |
| Valley Women's Clinic | Renton | Washington | — | — |
| North Spokane Women's Center | Spokane | Washington | — | — |
| Medical Associates Health Centers | Menomonee Falls | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01280981, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 26, 2011 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01280981 live on ClinicalTrials.gov.