Trial · NCT01280981
A Study of Tranexamic Acid (XP12B) in Women With Heavy Menstrual Bleeding
NCT01280981, Phase 3, Completed, Ferring Pharmaceuticals; results first posted 2011-07-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Tranexamic Acid (XP12B) in Women With Heavy Menstrual Bleeding. Trials, record NCT01280981. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01280981
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Tranexamic Acid (XP12B) in Women With Heavy Menstrual Bleeding
- NCT number
- NCT01280981
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 288 participants, actual
- Lead sponsor
- Ferring Pharmaceuticals
- Conditions
- Menorrhagia
- Interventions
- Tranexamic acid
- First posted
- 2011-01-21
- Last updated
- 2011-07-26
- Results first posted
- 2011-07-26
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants With Treatment-Emergent Adverse Events (AEs) | Day 1 to up to Month 9 | 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. |
| Secondary | Participants With Abnormal Gynecological Examinations | Day 1 to up to Month 9 | 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. |
| Secondary | Mean Blood Pressure Measurements at Week 36 | approximately week 36 | Mean systolic and diastolic blood pressure measurements taken at week 36 |
| Secondary | Participants With Treatment Emergent Adverse Experiences (TEAE) of Laboratory Values Related to Treatment | Day 1 to up to Month 9 | 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. |
| Secondary | Mean Intraocular Pressure at Month 9 | Day 1 up to Month 9 | Mean intraocular pressure at month 9 or the early termination visit. |
| Secondary | Mean Fridericia-corrected QT Interval (QTcFRI) at Month 9 | Month 9 | The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants With Treatment-Emergent Adverse Events (AEs) | Day 1 to up to Month 9 | Intent to treat population (ITT) | participants | NUMBER |
| SECONDARY | Participants With Abnormal Gynecological Examinations | Day 1 to up to Month 9 | Intent to treat population | participants | NUMBER |
| SECONDARY | Mean Blood Pressure Measurements at Week 36 | approximately week 36 | Intent to treat population of participants with week 36 blood pressure data. | mmHg | MEAN |
| SECONDARY | Participants With Treatment Emergent Adverse Experiences (TEAE) of Laboratory Values Related to Treatment | Day 1 to up to Month 9 | Intent to treat population | participants | NUMBER |
| SECONDARY | Mean Intraocular Pressure at Month 9 | Day 1 up to Month 9 | Intent to treat participants who had ophthalmic exams. | mmHg | MEAN |
| SECONDARY | Mean Fridericia-corrected QT Interval (QTcFRI) at Month 9 | Month 9 | Intent to treat participants who had an electrocardiogram (ECG) at month 9 | milliseconds | MEAN |
Source ClinicalTrials.gov
Results by group23
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants With Treatment-Emergent Adverse Events (AEs) | Tranexamic Acid | Any treatment-emergent AE | 218 | participants | |
| Participants With Treatment-Emergent Adverse Events (AEs) | Tranexamic Acid | Definitely related AE | 1 | participants | |
| Participants With Treatment-Emergent Adverse Events (AEs) | Tranexamic Acid | Probably related AE | 3 | participants | |
| Participants With Treatment-Emergent Adverse Events (AEs) | Tranexamic Acid | Possibly related AE | 60 | participants | |
| Participants With Treatment-Emergent Adverse Events (AEs) | Tranexamic Acid | Serious AE | 5 | participants | |
| Participants With Treatment-Emergent Adverse Events (AEs) | Tranexamic Acid | Life-threatening AE | 2 | participants | |
| Participants With Treatment-Emergent Adverse Events (AEs) | Tranexamic Acid | Died | 0 | participants | |
| Participants With Treatment-Emergent Adverse Events (AEs) | Tranexamic Acid | AE led to withdrawal from study | 6 | participants | |
| Participants With Treatment-Emergent Adverse Events (AEs) | Tranexamic Acid | Thrombotic or thromboembolic AE | 0 | participants | |
| Participants With Abnormal Gynecological Examinations | Tranexamic Acid | Significant results from endometrial biopsies | 0 | participants |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tranexamic Acid | 288 | |
| Overall Study | Intent to Treat (ITT) Population | Tranexamic Acid | 260 | |
| Overall Study | COMPLETED | Tranexamic Acid | 196 | |
| Overall Study | NOT COMPLETED | Tranexamic Acid | 92 |
Source ClinicalTrials.gov
Adverse events216
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Tranexamic Acid | 10 | 260 | |
| other | Ear congestion | Ear and labyrinth disorders | Tranexamic Acid | 1 | 260 | |
| other | Ear discomfort | Ear and labyrinth disorders | Tranexamic Acid | 1 | 260 | |
| other | Ear pain | Ear and labyrinth disorders | Tranexamic Acid | 4 | 260 | |
| other | Ear pruritus | Ear and labyrinth disorders | Tranexamic Acid | 1 | 260 | |
| other | Tympanic membrane disorder | Ear and labyrinth disorders | Tranexamic Acid | 1 | 260 | |
| other | Vertigo | Ear and labyrinth disorders | Tranexamic Acid | 3 | 260 | |
| other | Hypothyroidism | Endocrine disorders | Tranexamic Acid | 1 | 260 | |
| other | Chalazion | Eye disorders | Tranexamic Acid | 1 | 260 | |
| other | Conjunctivitis | Eye disorders | Tranexamic Acid | 1 | 260 |
1 to 10 of 216Source ClinicalTrials.gov
See all 216 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tranexamic Acid | ||
| Total, other adverse events | Tranexamic Acid | 218 | 260 |
| Total, serious adverse events | Tranexamic Acid | 5 | 260 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01280981
GET https://conductscience.org/api/trials/v1/NCT01280981/results?page=2