Trial · NCT00401193

Efficacy and Safety of XP12B in Women With Menorrhagia

NCT00401193, Phase 3, Completed, Ferring Pharmaceuticals; results first posted 2010-02-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of XP12B in Women With Menorrhagia. Trials, record NCT00401193. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00401193

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of XP12B in Women With Menorrhagia
NCT number: NCT00401193
Status: Completed
Phases: Phase 3
Enrollment: 304 participants, actual
Lead sponsor: Ferring Pharmaceuticals
Conditions: Menorrhagia, Heavy Menstrual Bleeding
Interventions: Tranexamic acid tablets, Tranexamic acid tablets, Placebo tablets
First posted: 2006-11-20
Last updated: 2015-05-13
Results first posted: 2010-02-24

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Reduction From Baseline in Menstrual Blood Loss (MBL)	Baseline MBL over 3 menstrual cycles	reduction of menstrual blood loss in mL
Secondary	Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding	Baseline scores over 3 menstrual cycles	A positive unit change of the mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited
Secondary	Patient Reported Outome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding	Baseline scores over 3 menstrual cycles	A positive unit change of the mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited
Secondary	Responder Analysis - Reduction in Large Stains	Baseline over 3 mentrual cycles	Percentage of subjects who experienced a reduction from baseline in the frequency of large stains

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Reduction From Baseline in Menstrual Blood Loss (MBL)	Baseline MBL over 3 menstrual cycles	modified intent to treat population	mL	LEAST_SQUARES_MEAN
SECONDARY	Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding	Baseline scores over 3 menstrual cycles	modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Patient Reported Outome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding	Baseline scores over 3 menstrual cycles	modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Responder Analysis - Reduction in Large Stains	Baseline over 3 mentrual cycles	modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)	percentage of 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	Value	Spread	Units
Mean Reduction From Baseline in Menstrual Blood Loss (MBL)	3900 mg/Day	65	Standard Deviation 51	mL
Mean Reduction From Baseline in Menstrual Blood Loss (MBL)	1950 mg/Day	44	Standard Deviation 57	mL
Mean Reduction From Baseline in Menstrual Blood Loss (MBL)	Placebo	7	Standard Deviation 46	mL
Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding	3900 mg/Day	1.0	Standard Deviation 1.1	units on a scale
Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding	Placebo	0.4	Standard Deviation 0.8	units on a scale
Patient Reported Outome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding	3900 mg/Day	0.9	Standard Deviation 1.0	units on a scale
Patient Reported Outome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding	Placebo	0.3	Standard Deviation 0.8	units on a scale
Responder Analysis - Reduction in Large Stains	3900 mg/Day	64		percentage of participants
Responder Analysis - Reduction in Large Stains	Placebo	52		percentage of participants

Source ClinicalTrials.gov

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	3900 mg/Day	118
Overall Study	STARTED	1950 mg/Day	117
Overall Study	STARTED	Placebo	69
Overall Study	Intent to Treat Population	3900 mg/Day	115
Overall Study	Intent to Treat Population	1950 mg/Day	115
Overall Study	Intent to Treat Population	Placebo	67
Overall Study	Modified Intent to Treat Population	3900 mg/Day	112
Overall Study	Modified Intent to Treat Population	1950 mg/Day	115
Overall Study	Modified Intent to Treat Population	Placebo	67
Overall Study	COMPLETED	3900 mg/Day	103

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events42

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
other	Abdominal Pain	Gastrointestinal disorders	3900 mg/Day	23	115
other	Abdominal Pain	Gastrointestinal disorders	1950 mg/Day	24	115
other	Abdominal Pain	Gastrointestinal disorders	Placebo	15	67
other	Anemia	Blood and lymphatic system disorders	3900 mg/Day	1	115
other	Anemia	Blood and lymphatic system disorders	1950 mg/Day	6	115
other	Anemia	Blood and lymphatic system disorders	Placebo	1	67
other	Arthralgia	Musculoskeletal and connective tissue disorders	3900 mg/Day	5	115
other	Arthralgia	Musculoskeletal and connective tissue disorders	1950 mg/Day	7	115
other	Arthralgia	Musculoskeletal and connective tissue disorders	Placebo	1	67
other	Back Pain	Musculoskeletal and connective tissue disorders	3900 mg/Day	20	115

1 to 10 of 42Source ClinicalTrials.gov

See all 42 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	3900 mg/Day
Total, all-cause mortality	1950 mg/Day
Total, all-cause mortality	Placebo
Total, other adverse events	3900 mg/Day	97	115
Total, other adverse events	1950 mg/Day	104	115
Total, other adverse events	Placebo	56	67
Total, serious adverse events	3900 mg/Day	1	115
Total, serious adverse events	1950 mg/Day	1	115
Total, serious adverse events	Placebo	0	67

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
20942615	DERIVED	PubMed
21777897	DERIVED	PubMed

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00401193

GET https://conductscience.org/api/trials/v1/NCT00401193/events?page=2

API reference For AI assistants