Trial · NCT00113568
Safety Study of XP12B in Women With Menorrhagia
NCT00113568, Phase 3, Completed, Ferring Pharmaceuticals; results first posted 2010-01-20
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Safety Study of XP12B in Women With Menorrhagia. Trials, record NCT00113568. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00113568
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of XP12B in Women With Menorrhagia
- NCT number
- NCT00113568
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 784 participants, actual
- Lead sponsor
- Ferring Pharmaceuticals
- Conditions
- Menorrhagia, Heavy Menstrual Bleeding
- Interventions
- Tranexamic acid tablets (XP12B)
- First posted
- 2005-06-09
- Last updated
- 2010-06-15
- Results first posted
- 2010-01-20
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With at Least One Adverse Event During the Study | Up to 27 menstrual cycles | An adverse event is any untoward, undesired, unplanned clinical event in the form of signs. symptoms, disease, or laboratory or physiological observations occurring in a human being participating in a clinical study with a sponsor study drug, regardless of causal relationship. |
| Primary | Number of Subjects With at Least One Possibly Treatment-Related Adverse Event During the Study | Up to 27 menstrual cycles | The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A possibly treatment-related adverse event is an event that may be explained by administration of the study drug or by the subjects's clinical state or other agents/therapies. |
| Primary | Number of Subjects With at Least One Probably Treatment-Related Adverse Event During the Study | Up to 27 menstrual cycles | The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A probably treatment-related adverse event is an event most likely to be explained by administration of the study drug rather than the subjects's clinical state or other agents/therapies. |
| Primary | Number of Subjects With at Least One Definitely Treatment-Related Adverse Event During the Study | Up to 27 menstrual cycles | The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A definitely treatment-related adverse event is an event that can be fully explained by administration of the study drug. |
| Primary | Number of Subjects With at Least One Serious Adverse Event During the Study | Up to 27 menstrual cycles | A serious adverse event (SAE) is any adverse event (AE) occurring at any dose that meets 1 or more of the following criteria: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in a persistent or significant disability or incapacity; results in cancer; results in a congenital anomaly or birth defect. Important medical events not described above may be considered SAEs when based on appropriate medical judgment. |
| Primary | Number of Subjects With at Least One Life-Threatening Adverse Event During the Study | Up to 27 menstrual cycles | A life-threatening AE is any AE that places the subject at immediate risk of death from the event as it occurred. |
| Primary | Number of Subjects With Adverse Events That Led to Discontinuation From the Study | Up to 27 menstrual cycles | The total number of subjects who withdrew from the study due to an adverse event irrespective of the causal relation between the AE and the study drug as determined by the investigator |
| Primary | Number of Subjects With Any Thrombotic or Thromboembolic Adverse Event During the Study | Up to 27 menstrual cycles | Examples include deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, central retinal artery and vein obstruction. |
| Primary | Number of Subjects Who Died During the Study | Up to 27 menstrual cycles | Number of subjects who died, for any reason, during the study |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With at Least One Adverse Event During the Study | Up to 27 menstrual cycles | intent to treat population | participants | NUMBER |
| PRIMARY | Number of Subjects With at Least One Possibly Treatment-Related Adverse Event During the Study | Up to 27 menstrual cycles | intent to treat population | participants | NUMBER |
| PRIMARY | Number of Subjects With at Least One Probably Treatment-Related Adverse Event During the Study | Up to 27 menstrual cycles | intent to treat population | participants | NUMBER |
| PRIMARY | Number of Subjects With at Least One Definitely Treatment-Related Adverse Event During the Study | Up to 27 menstrual cycles | intent to treat population | participants | NUMBER |
| PRIMARY | Number of Subjects With at Least One Serious Adverse Event During the Study | Up to 27 menstrual cycles | intent to treat population | participants | NUMBER |
| PRIMARY | Number of Subjects With at Least One Life-Threatening Adverse Event During the Study | Up to 27 menstrual cycles | intent to treat population | participants | NUMBER |
| PRIMARY | Number of Subjects With Adverse Events That Led to Discontinuation From the Study | Up to 27 menstrual cycles | participants | NUMBER | |
| PRIMARY | Number of Subjects With Any Thrombotic or Thromboembolic Adverse Event During the Study | Up to 27 menstrual cycles | intent to treat population | participants | NUMBER |
| PRIMARY | Number of Subjects Who Died During the Study | Up to 27 menstrual cycles | participants | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With at Least One Adverse Event During the Study | Tranexamic Acid Tablets (XP12B) | 678 | participants | ||
| Number of Subjects With at Least One Possibly Treatment-Related Adverse Event During the Study | Tranexamic Acid Tablets (XP12B) | 306 | participants | ||
| Number of Subjects With at Least One Probably Treatment-Related Adverse Event During the Study | Tranexamic Acid Tablets (XP12B) | 40 | participants | ||
| Number of Subjects With at Least One Definitely Treatment-Related Adverse Event During the Study | Tranexamic Acid Tablets (XP12B) | 13 | participants | ||
| Number of Subjects With at Least One Serious Adverse Event During the Study | Tranexamic Acid Tablets (XP12B) | 28 | participants | ||
| Number of Subjects With at Least One Life-Threatening Adverse Event During the Study | Tranexamic Acid Tablets (XP12B) | 2 | participants | ||
| Number of Subjects With Adverse Events That Led to Discontinuation From the Study | Tranexamic Acid Tablets (XP12B) | 97 | participants | ||
| Number of Subjects With Any Thrombotic or Thromboembolic Adverse Event During the Study | Tranexamic Acid Tablets (XP12B) | 0 | participants | ||
| Number of Subjects Who Died During the Study | Tranexamic Acid Tablets (XP12B) | 1 | participants |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tranexamic Acid Tablets (XP12B) | 784 | |
| Overall Study | Intent to Treat Population | Tranexamic Acid Tablets (XP12B) | 723 | |
| Overall Study | COMPLETED | Tranexamic Acid Tablets (XP12B) | 239 | |
| Overall Study | NOT COMPLETED | Tranexamic Acid Tablets (XP12B) | 545 |
Source ClinicalTrials.gov
Adverse events64
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 | Anemia | Blood and lymphatic system disorders | Tranexamic Acid Tablets (XP12B) | 37 | 723 | |
| other | Abdominal Discomfort | Gastrointestinal disorders | Tranexamic Acid Tablets (XP12B) | 87 | 723 | |
| other | Upper abdominal pain | Gastrointestinal disorders | Tranexamic Acid Tablets (XP12B) | 65 | 723 | |
| other | Diarrhea | Gastrointestinal disorders | Tranexamic Acid Tablets (XP12B) | 88 | 723 | |
| other | Dyspepsia | Gastrointestinal disorders | Tranexamic Acid Tablets (XP12B) | 60 | 723 | |
| other | Nausea | Gastrointestinal disorders | Tranexamic Acid Tablets (XP12B) | 104 | 723 | |
| other | Toothache | Gastrointestinal disorders | Tranexamic Acid Tablets (XP12B) | 42 | 723 | |
| other | Vomiting | Gastrointestinal disorders | Tranexamic Acid Tablets (XP12B) | 43 | 723 | |
| other | Fatigue | General disorders | Tranexamic Acid Tablets (XP12B) | 57 | 723 | |
| other | Multiple allergies | Immune system disorders | Tranexamic Acid Tablets (XP12B) | 39 | 723 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tranexamic Acid Tablets (XP12B) | ||
| Total, other adverse events | Tranexamic Acid Tablets (XP12B) | 678 | 723 |
| Total, serious adverse events | Tranexamic Acid Tablets (XP12B) | 28 | 723 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT00113568
GET https://conductscience.org/api/trials/v1/NCT00113568/events?page=2