MenorrhagiaPhase 3NCT00401193

Efficacy and Safety of XP12B in Women With Menorrhagia

A Phase 3 study testing Tranexamic acid tablets in people with Menorrhagia and Heavy Menstrual Bleeding, run by Ferring Pharmaceuticals at 83 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether XP12B is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia. Read more about this study

Who is it for?: Ages 18 to 49 years, women only
Conditions the study is for: Menorrhagia, Heavy Menstrual Bleeding
What is being tested?: Tranexamic acid tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 304 participants
Where: 83 sitesUnited States
Study dates: Nov 2006to May 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 49 years
Women only
No healthy volunteers
Adult

Who may be able to join

Women with menorrhagia
18-49 years of age
Regularly occurring menstrual periods

Who cannot join

History or presence of clinically significant disease or abnormalities that may confound the study
History of bilateral oophorectomy or hysterectomy
Hormone therapy for birth control

Trial locations and contacts

83 sites in 1 country.

City, postcode or hospital

83 sites in 1 country

United States83 sites

Investigative Site
Albuquerque, New Mexico, 87131
Investigative Site
Ann Arbor, Michigan, 48106
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Atlanta, Georgia, 30328
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Austin, Texas, 78737
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Baltimore, Maryland, 21230
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Bingham Farms, Michigan, 48025
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Birmingham, Alabama, 35209
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Bismarck, North Dakota, 58501
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Bloomington, Indiana, 47403
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Boise, Idaho, 83712
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Bristol, Tennessee, 37620
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Bryan, Texas, 77802
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Burlington, Vermont, 05401
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Clarksville, Tennessee, 37043
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Cleveland, Ohio, 44121
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Cleveland, Ohio, 44122
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Decatur, Georgia, 30033
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Denver, Colorado, 80202
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Durham, North Carolina, 27713
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Eugene, Oregon, 97401
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Fort Worth, Texas, 76132
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Gainesville, Florida, 32610
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Gallipolis, Ohio, 45631
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Grand Rapids, Michigan, 49506
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Greenville, South Carolina, 29605
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Groton, Connecticut, 06340
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Houston, Texas, 77030
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Idaho Falls, Idaho, 83404
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Jacksonville, Florida, 32216
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Kansas City, Missouri, 64114
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Las Vegas, Nevada, 89128
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Lawrenceville, New Jersey, 08648
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Levittown, Pennsylvania, 19056
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Lighthouse PT, Florida, 33064
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Little Rock, Arkansas, 72205
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Los Alamitos, California, 90720
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Los Angeles, California, 90027
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Marrero, Louisiana, 70072
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McCook, Nebraska, 69001
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Miami, Florida, 33186
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Miami Beach, Florida, 33141
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Missoula, Montana, 59808
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Moorestown, New Jersey, 08057
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Nashville, Tennessee, 37203
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New Brunswick, New Jersey, 08903
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New Port Richey, Florida, 34652
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New York, New York, 10017
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Newton, Kansas, 67114
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Norfolk, Virginia, 23502
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Oklahoma City, Oklahoma, 73104
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Oklahoma City, Oklahoma, 73112
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Overland Park, Kansas, 66215
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Paw Paw, Michigan, 49079
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Philadelphia, Pennsylvania, 19104
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Philadelphia, Pennsylvania, 19114
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Phoenix, Arizona, 85015
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Phoenixville, Pennsylvania, 19460
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Plano, Texas, 75093
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Pleasant Grove, Utah, 84062
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Portland, Oregon, 97205
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Raleigh, North Carolina, 27607
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Renton, Washington, 98055
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Richmond, Virginia, 23225
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Rochester, New York, 14621
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Saint Clair Shores, Michigan, 48081
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Salt Lake City, Utah, 84124
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San Diego, California, 92108
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Sarasota, Florida, 34233
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Searcy, Arkansas, 72143
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Sioux Falls, South Dakota, 57104
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Strafford, Pennsylvania, 19087
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Temple, Texas, 46502
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The Woodlands, Texas, 77380
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Tucson, Arizona, 85710
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Tucson, Arizona, 85712
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Waco, Texas, 76712
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Webster, Texas, 77598
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West Jordan, Utah, 84088
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West Valley City, Utah, 84120
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Wexford, Pennsylvania, 15090
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Winston-Salem, North Carolina, 27103
Investigative Site
Wynnewood, Pennsylvania, 19096
Investigative Site
Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study To Evaluate Efficacy and Safety of XP12B for the Treatment of Menorrhagia

The purpose of this study is to determine whether XP12B is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia.

Conditions: Menorrhagia, Heavy Menstrual Bleeding
Being tested: Tranexamic acid tablets, Placebo tablets
Keywords: Menorrhagia, Heavy Menstrual Bleeding
Medical subject headings: Menorrhagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tranexamic acid tabletsDrug
Also called Lysteda, XP12B
3900 mg/Day
Tranexamic acid tabletsDrug
Also called Lysteda, XP12B
1950 mg/Day
Placebo tabletsDrug

Study groups in NCT00401193
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: Tranexamic acid tablets
2	Experimental	Not described Receives: Drug: Tranexamic acid tablets
3	Placebo comparator	Not described Receives: Drug: Placebo tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Reduction From Baseline in Menstrual Blood Loss (MBL)
reduction of menstrual blood loss in mL
Measured: Baseline MBL over 3 menstrual cycles

Secondary outcomes (3)

Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding
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
Measured: Baseline scores over 3 menstrual cycles
Patient Reported Outome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding
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
Measured: Baseline scores over 3 menstrual cycles
Responder Analysis - Reduction in Large Stains
Percentage of subjects who experienced a reduction from baseline in the frequency of large stains
Measured: Baseline over 3 mentrual cycles

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2006May 2008

First posted20 Nov 2006 (estimated)
Study startNov 2006
Primary completionMay 2008
Study completionMay 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for MenorrhagiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 304 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00401193
Sponsor's protocol ID: XP12B-MR-301
Status last verified: Apr 2015
First submitted: 9 Nov 2006
Last updated: 13 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Freeman EW, Lukes A, VanDrie D, Mabey RG, Gersten J, Adomako TL. A dose-response study of a novel, oral tranexamic formulation for heavy menstrual bleeding. Am J Obstet Gynecol. 2011 Oct;205(4):319.e1-7. doi: 10.1016/j.ajog.2011.05.015. Epub 2011 May 14.
PubMed 21777897
Lukes AS, Muse K, Richter HE, Moore KA, Patrick DL. Estimating a meaningful reduction in menstrual blood loss for women with heavy menstrual bleeding. Curr Med Res Opin. 2010 Nov;26(11):2673-8. doi: 10.1185/03007995.2010.526098. Epub 2010 Oct 13.
PubMed 20942615

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Heavy Menstrual Bleeding, Bleeding Disorder
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A Clinical Study of the Aqua Therapeutics Thermal Therapy Vapor Ablation System in Premenopausal Women With Abnormal Uterine Bleeding
Menorrhagia
RecruitingPhase 2
HMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB
Von Willebrand Disease (VWD), Heavy Menstrual Bleeding (HMB)
Recruiting
Delivering tAN to Reduce HMB: The LUNA Study
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All Menorrhagia trials

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study To Evaluate Efficacy and Safety of XP12B for the Treatment of Menorrhagia
ClinicalTrials.gov ID: NCT00401193
Acronym / sponsor ID: XP12B-MR-301
Conditions: Menorrhagia, Heavy Menstrual Bleeding
Keywords: Menorrhagia, Heavy Menstrual Bleeding
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 304 participants (actual)
Lead sponsor: Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Nov 2006
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 20 Nov 2006 (estimated)
Results: Posted 24 Feb 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine whether XP12B is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: Tranexamic acid tablets
2	Experimental	Drug: Tranexamic acid tablets
3	Placebo comparator	Drug: Placebo tablets

Who may qualify

Ages: 18 to 49 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Women with menorrhagia
18-49 years of age
Regularly occurring menstrual periods

Key exclusion criteria (3 listed)

History or presence of clinically significant disease or abnormalities that may confound the study
History of bilateral oophorectomy or hysterectomy
Hormone therapy for birth control

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tranexamic acid tabletsAlso: Lysteda, XP12B3900 mg/Day	Drug	1
Tranexamic acid tabletsAlso: Lysteda, XP12B1950 mg/Day	Drug	2
Placebo tablets	Drug	3

Primary outcome

Mean Reduction From Baseline in Menstrual Blood Loss (MBL)
Time frame: Baseline MBL over 3 menstrual cycles
reduction of menstrual blood loss in mL

3 secondary outcomes

Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding
Time frame: Baseline scores over 3 menstrual cycles
Patient Reported Outome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding
Time frame: Baseline scores over 3 menstrual cycles
Responder Analysis - Reduction in Large Stains
Time frame: Baseline over 3 mentrual cycles

Results and safety

Results posted to the registry on 24 Feb 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
3900 mg/Day	118	103
1950 mg/Day	117	106
Placebo	69	63

Primary outcome: Mean Reduction From Baseline in Menstrual Blood Loss (MBL)

Time frame: Baseline MBL over 3 menstrual cycles. Least squares mean (Standard Deviation). Unit: mL

Measure	3900 mg/Day n = 112	1950 mg/Day n = 115	Placebo n = 67
Value	65 (51)	44 (57)	7 (46)

Population analysed: modified intent to treat population

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
3900 mg/Day	1 of 115 (0.9%)	97 of 115 (84.3%)	Not reported
1950 mg/Day	1 of 115 (0.9%)	104 of 115 (90.4%)	Not reported
Placebo	0 of 67 (0%)	56 of 67 (83.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21777897Freeman EW, Lukes A, VanDrie D, Mabey RG, Gersten J, Adomako TL. A dose-response study of a novel, oral tranexamic formulation for heavy menstrual bleeding. Am J Obstet Gynecol. 2011 Oct;205(4):319.e1-7. doi: 10.1016/j.ajog.2011.05.015. Epub 2011 May 14.
Derived from this study: PubMed 20942615Lukes AS, Muse K, Richter HE, Moore KA, Patrick DL. Estimating a meaningful reduction in menstrual blood loss for women with heavy menstrual bleeding. Curr Med Res Opin. 2010 Nov;26(11):2673-8. doi: 10.1185/03007995.2010.526098. Epub 2010 Oct 13.

Related trials for Menorrhagia

RecruitingObservational study
Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study
Heavy Menstrual Bleeding, Bleeding Disorder
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
Recruiting
A Clinical Study of the Aqua Therapeutics Thermal Therapy Vapor Ablation System in Premenopausal Women With Abnormal Uterine Bleeding
Menorrhagia
RecruitingPhase 2
HMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB
Von Willebrand Disease (VWD), Heavy Menstrual Bleeding (HMB)
Recruiting
Delivering tAN to Reduce HMB: The LUNA Study
Heavy Menstrual Bleeding

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Development Support study director

Ferring Pharmaceuticals

83 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tranexamic acid tablets in people with Menorrhagia and Heavy Menstrual Bleeding, run by Ferring Pharmaceuticals at 83 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Reduction From Baseline in Menstrual Blood Loss (MBL) (time frame: Baseline MBL over 3 menstrual cycles). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00401193, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2015.