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NCT01280981 · ClinicalTrials.gov registry record · Phase 3
A Study of Tranexamic Acid (XP12B) in Women With Heavy Menstrual Bleeding
A Phase 3 study of Menorrhagia, sponsored by Ferring Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 288
- Enrollment target
- 20
- Study locations
NCT01280981: Completed Phase 3 study of Menorrhagia, sponsored by Ferring Pharmaceuticals.
NCT01280981 is a Phase 3 study of Menorrhagia that has completed, run by Ferring Pharmaceuticals. The registered enrollment target is 288 participants, above the 200-participant average among 10 other Menorrhagia trials with a reported enrollment target (44% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01280981, a Phase 3 study of Menorrhagia, has completed, sponsored by Ferring Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 288 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Tranexamic acid
Study Locations (20)
Arizona
- Women's Health Research - Phoenix
- Genova Clinical Research - Tucson
- Quality of Life Medical and Research Center - Tucson
- Radiant Research - Tucson
- Visions Clinical Research - Tucson
California
- Northern California Research Corp - Carmichael
- Physicians' Research Options, LC - Lakewood
- Sklar Center for Women's Wellness - Los Alamitos
- Medical Center for Clinical Research - San Diego
- INC Clinical Trials - Upland
Florida
- Nature Coast Clinical Research - Crystal River
- University of Florida - Gainesville
- Jacksonville Center for Clinical Research - Jacksonville
- New Age Medical Research Corp - Miami
- University of Miami Cedars Medical Center - Miami
Arkansas
- Lynn Institute of the Ozarks - Little Rock
- Searcy Medical Center - Searcy
Colorado
- Advanced Women's Health Institute - Denver
- Downtown Women's Health Care - Denver
Alabama
- Radiant Research - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 288 participants |
| Start Date | 2007-04 |
| Est. Completion | 2009-05 |
| Phase | Phase 3 |
What the finished NCT01280981 record still lists
NCT01280981 is an interventional study that assigns participants to a tested intervention. The registered 288 participants enrollment target is mid-sized for trials with a published cap, above the 200-participant average among 10 other Menorrhagia trials with a reported enrollment target (44% higher).
The record links to 1 condition, with Menorrhagia appearing as the primary indexed condition, and to 1 intervention - of which Tranexamic acid is the first listed.
NCT01280981 names 20 study sites across 6 states, led by Arizona, California, Florida.
Frequently Asked Questions
What is clinical trial NCT01280981 about?
NCT01280981 is a clinical study titled "A Study of Tranexamic Acid (XP12B) in Women With Heavy Menstrual Bleeding". 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 ...
What is the current status of trial NCT01280981?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 288 participants. The study started on 2007-04. Estimated completion is 2009-05.
What conditions does trial NCT01280981 study?
This clinical trial studies the following conditions: Menorrhagia.
What interventions are being tested in trial NCT01280981?
The interventions under investigation include: Tranexamic acid (DRUG).
Who is sponsoring clinical trial NCT01280981?
This trial is sponsored by Ferring Pharmaceuticals, which has 83 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01280981 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Menorrhagia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01280981's enrollment target sits among peer trials
288 3rd of 10 higher than 8 of 10 other Menorrhagia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Menorrhagia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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