Trial · NCT01428713
Tranexamic Acid (TA) vs Combined Oral Contraceptive (COCP) Pilot Study
NCT01428713, Not applicable, Completed, Baylor College of Medicine; results first posted 2014-09-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tranexamic Acid (TA) vs Combined Oral Contraceptive (COCP) Pilot Study. Trials, record NCT01428713. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01428713
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tranexamic Acid (TA) vs Combined Oral Contraceptive (COCP) Pilot Study
- NCT number
- NCT01428713
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 17 participants, actual
- Lead sponsor
- Baylor College of Medicine
- Conditions
- Menorrhagia
- Interventions
- Oral tranexamic acid, Oral Contraceptive Pills
- First posted
- 2011-09-05
- Last updated
- 2016-08-10
- Results first posted
- 2014-09-17
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To Assess the Efficacy of Oral TA and COCP in Adolescents With Menorrhagia. | Baseline, 3 cycles | To assess 1. change in Pictorial Blood Assessment Chart Score (PBAC Score) from baseline to the end of 3 cycles of TA 2. change in quality of life (QOL) as evaluated by the PedsQL instrument from baseline to the end of 3 cycles of TA 3. change in Pictorial Blood Assessment Chart Score (PBAC Score) from baseline to the end of 3 cycles of COCP 4. change in quality of life (QOL) as evaluated by the PedsQL instrument from baseline to the end of 3 cycles of COCP PBAC score: Quantitative score to measure menstrual blood loss. Scale range: Minimum - 0 score, Maximum: No maximum Interpretation: Score \> 100 indicates heavy menstrual bleeding Peds QL score: Score to measure quality of life in children Scale range: Minimum: 0, Maximum 100 Calculation: Subscales are reverse scored (using formula 100 - a x 25) and then all subscales are averaged Eg: Subscale score of 3 is reverse scored as: 100 - (3 x 25) = 25 Interpretation: Higher score indicates better quality of life |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | To Assess the Efficacy of Oral TA and COCP in Adolescents With Menorrhagia. | Baseline, 3 cycles | 10 patients completed TA and their results were analyzed. 11 patients completed COCP and their results were analyzed. | Scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| To Assess the Efficacy of Oral TA and COCP in Adolescents With Menorrhagia. | Group: TA | PBAC (Pictorial Blood Assessment Chart) score | 536.4 | Standard Error 162.12 | Scores on a scale |
| To Assess the Efficacy of Oral TA and COCP in Adolescents With Menorrhagia. | Group: COCP | PBAC (Pictorial Blood Assessment Chart) score | 430.6 | Standard Error 157.35 | Scores on a scale |
| To Assess the Efficacy of Oral TA and COCP in Adolescents With Menorrhagia. | Group: TA | Peds QL (Pediatric Quality of Life) score | 15.6 | Standard Error 5.08 | Scores on a scale |
| To Assess the Efficacy of Oral TA and COCP in Adolescents With Menorrhagia. | Group: COCP | Peds QL (Pediatric Quality of Life) score | 16.75 | Standard Error 4.87 | Scores on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group A: TA First, Then COCP | 9 | |
| Overall Study | STARTED | Group B: COCP First, Then TA | 8 | |
| Overall Study | COMPLETED | Group A: TA First, Then COCP | 6 | |
| Overall Study | COMPLETED | Group B: COCP First, Then TA | 3 | |
| Overall Study | NOT COMPLETED | Group A: TA First, Then COCP | 3 | |
| Overall Study | NOT COMPLETED | Group B: COCP First, Then TA | 5 |
Source ClinicalTrials.gov
Adverse events18
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 | breakthrough bleeding | Reproductive system and breast disorders | Tranexamic Acid (TA) | 1 | 10 | 1 |
| other | breakthrough bleeding | Reproductive system and breast disorders | Combined Oral Contraceptives (COCP) | 1 | 11 | 1 |
| other | nausea/vomiting | General disorders | Tranexamic Acid (TA) | 1 | 10 | 1 |
| other | nausea/vomiting | General disorders | Combined Oral Contraceptives (COCP) | 1 | 11 | 1 |
| other | abdominal pain | General disorders | Tranexamic Acid (TA) | 0 | 10 | 0 |
| other | abdominal pain | General disorders | Combined Oral Contraceptives (COCP) | 1 | 11 | 1 |
| other | headache | General disorders | Tranexamic Acid (TA) | 0 | 10 | 0 |
| other | headache | General disorders | Combined Oral Contraceptives (COCP) | 1 | 11 | 1 |
| other | weight gain | General disorders | Tranexamic Acid (TA) | 0 | 10 | 0 |
| other | weight gain | General disorders | Combined Oral Contraceptives (COCP) | 1 | 11 | 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tranexamic Acid (TA) | ||
| Total, all-cause mortality | Combined Oral Contraceptives (COCP) | ||
| Total, other adverse events | Tranexamic Acid (TA) | 2 | 10 |
| Total, other adverse events | Combined Oral Contraceptives (COCP) | 8 | 11 |
| Total, serious adverse events | Tranexamic Acid (TA) | 0 | 10 |
| Total, serious adverse events | Combined Oral Contraceptives (COCP) | 0 | 11 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Tranexamic Acid (TA) vs Combined Oral Contraceptives (COCP): serious adverse events |
Source Trial comparisons
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/NCT01428713
GET https://conductscience.org/api/trials/v1/NCT01428713/registered