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MenorrhagiaPhase 3NCT00386308

Efficacy and Safety Study 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 52 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
196 participants
Where
52 sitesUnited States
Study dates
Oct 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

Trial locations and contacts

52 sites in 1 country.

52 sites in 1 country

United States52 sites

  • Investigative Site

    Abington, Pennsylvania, 19001

  • Investigative Site

    Amite, Louisiana, 70422

  • Investigative Site

    Atlanta, Georgia, 30328

  • Investigative Site

    Atlanta, Georgia, 30342

  • Investigative Site

    Baton Rouge, Louisiana, 70808

  • Investigative Site

    Canfield, Ohio, 44406

  • Investigative Site

    Carmichael, California, 95608

  • Investigative Site

    Centerville, Ohio, 45459

  • Investigative Site

    Charleston, South Carolina, 29401

  • Investigative Site

    Charleston, West Virginia, 25301

  • Investigative Site

    Chattanooga, Tennessee, 37403

  • Investigative Site

    Cleveland, Ohio, 44122

  • Investigative Site

    Columbia, South Carolina, 29201

  • Investigative Site

    Dallas, Texas, 75235

  • Investigative Site

    Decatur, Georgia, 30033

  • Investigative Site

    Denver, Colorado, 80206

  • Investigative Site

    Eugene, Oregon, 97401

  • Investigative Site

    Greenville, South Carolina, 29615

  • Investigative Site

    Greer, South Carolina, 29651

  • Investigative Site

    Groton, Connecticut, 06340

  • Investigative Site

    Houston, Texas, 77030

  • Investigative Site

    Huntington, West Virginia, 25701

  • Investigative Site

    Idaho Falls, Idaho, 83404

  • Investigative Site

    Inverness, Florida, 34452

  • Investigative Site

    Jenkintown, Pennsylvania, 19046

  • Investigative Site

    Knoxville, Tennessee, 37920

  • Investigative Site

    Lakewood, Colorado, 80228

  • Investigative Site

    Lawrenceville, New Jersey, 08648

  • Investigative Site

    Little Rock, Arkansas, 72205

  • Investigative Site

    Marrero, Louisiana, 70072

  • Investigative Site

    Medford, Oregon, 97504

  • Investigative Site

    Memphis, Tennessee, 38119

  • Investigative Site

    Menomonee Falls, Wisconsin, 53051

  • Investigative Site

    Miami, Florida, 33133

  • Investigative Site

    Miami, Florida, 33136

  • Investigative Site

    Norman, Oklahoma, 73071

  • Investigative Site

    Oklahoma City, Oklahoma, 73112

  • Investigative Site

    Paw Paw, Michigan, 49079

  • Investigative Site

    Portland, Oregon, 97210

  • Investigative Site

    Reading, Pennsylvania, 19606

  • Investigative Site

    Salem, Oregon, 97301

  • Investigative Site

    San Diego, California, 92123

  • Investigative Site

    Sandy City, Utah, 84070

  • Investigative Site

    Savannah, Georgia, 31406

  • Investigative Site

    Scottsbluff, Nebraska, 69361

  • Investigative Site

    Shreveport, Louisiana, 71115

  • Investigative Site

    Spokane, Washington, 99207

  • Investigative Site

    Tucson, Arizona, 85712

  • Investigative Site

    Tucson, Arizona, 85741

  • Investigative Site

    Upland, California, 91786

  • Investigative Site

    West Hartford, Connecticut, 06117

  • 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.

Being tested
Tranexamic acid tablets, Placebo tablets
Keywords
Heavy Menstrual Bleeding, Menorrhagia
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

  • Placebo tabletsDrug

    Also called Lysteda, XP12B

Study groups in NCT00386308
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: Tranexamic acid tablets
2Placebo comparatorNot described
Receives: Drug: Placebo tablets

What is being measured

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

  1. Mean Reduction From Baseline in Menstrual Blood Loss (MBL)

    reduction of menstrual blood loss in mL

    Measured: Baseline MBL over 6 menstrual cycles

Secondary outcomes (3)

  1. Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding

    A positive unit change 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: Change from Baseline scores over 6 menstrual cycles

  2. Patient Reported Outcome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding

    A positive unit change 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: Change from Baseline scores over 6 menstrual cycles

  3. Responder Analysis - Reduction in Large Stains

    Percentage of subjects who experienced a reduction from baseline in the frequency of large stains

    Measured: Reduction from Baseline over 6 menstrual cycles

Timeline

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

  1. First posted11 Oct 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionMay 2008
  4. Study completionMay 2008

Resources

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
196 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00386308
Sponsor's protocol ID
XP12B-MR-303
Status last verified
Jun 2010
First submitted
6 Oct 2006
Last updated
4 May 2011
Data monitoring committee
Yes

Publications

  • Bushnell DM, Martin ML, Moore KA, Richter HE, Rubin A, Patrick DL. Menorrhagia Impact Questionnaire: assessing the influence of heavy menstrual bleeding on quality of life. Curr Med Res Opin. 2010 Dec;26(12):2745-55. doi: 10.1185/03007995.2010.532200. Epub 2010 Nov 3.

    PubMed 21043553

  • Lukes AS, Moore KA, Muse KN, Gersten JK, Hecht BR, Edlund M, Richter HE, Eder SE, Attia GR, Patrick DL, Rubin A, Shangold GA. Tranexamic acid treatment for heavy menstrual bleeding: a randomized controlled trial. Obstet Gynecol. 2010 Oct;116(4):865-875. doi: 10.1097/AOG.0b013e3181f20177.

    PubMed 20859150

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 52 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 4 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 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 22 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 6 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 NCT00386308, 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 4 May 2011.

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