Efficacy and Safety of XP12B in Women With Menorrhagia
Sponsor
Ferring Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00401193
Collaborator
(none)
304
83
3
18
3.7
0.2
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
304 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study To Evaluate Efficacy and Safety of XP12B for the Treatment of Menorrhagia
Study Start Date
:
Nov 1, 2006
Actual Primary Completion Date
:
May 1, 2008
Actual Study Completion Date
:
May 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: Tranexamic acid tablets
3900 mg/Day
Other Names:
|
| Experimental: 2
|
Drug: Tranexamic acid tablets
1950 mg/Day
Other Names:
|
| Placebo Comparator: 3
|
Drug: Placebo tablets
|
Outcome Measures
Primary Outcome Measures
- Mean Reduction From Baseline in Menstrual Blood Loss (MBL) [Baseline MBL over 3 menstrual cycles]
reduction of menstrual blood loss in mL
Secondary Outcome Measures
- 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
- 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
- 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
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 49 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Women with menorrhagia
-
18-49 years of age
-
Regularly occurring menstrual periods
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Investigative Site | Birmingham | Alabama | United States | 35209 |
| 2 | Investigative Site | Phoenix | Arizona | United States | 85015 |
| 3 | Investigative Site | Tucson | Arizona | United States | 85710 |
| 4 | Investigative Site | Tucson | Arizona | United States | 85712 |
| 5 | Investigative Site | Little Rock | Arkansas | United States | 72205 |
| 6 | Investigative Site | Searcy | Arkansas | United States | 72143 |
| 7 | Investigative Site | Los Alamitos | California | United States | 90720 |
| 8 | Investigative Site | Los Angeles | California | United States | 90027 |
| 9 | Investigative Site | San Diego | California | United States | 92108 |
| 10 | Investigative Site | Denver | Colorado | United States | 80202 |
| 11 | Investigative Site | Groton | Connecticut | United States | 06340 |
| 12 | Investigative Site | Gainesville | Florida | United States | 32610 |
| 13 | Investigative Site | Jacksonville | Florida | United States | 32216 |
| 14 | Investigative Site | Lighthouse Point | Florida | United States | 33064 |
| 15 | Investigative Site | Miami Beach | Florida | United States | 33141 |
| 16 | Investigative Site | Miami | Florida | United States | 33186 |
| 17 | Investigative Site | New Port Richey | Florida | United States | 34652 |
| 18 | Investigative Site | Sarasota | Florida | United States | 34233 |
| 19 | Investigative Site | Atlanta | Georgia | United States | 30328 |
| 20 | Investigative Site | Decatur | Georgia | United States | 30033 |
| 21 | Investigative Site | Boise | Idaho | United States | 83712 |
| 22 | Investigative Site | Idaho Falls | Idaho | United States | 83404 |
| 23 | Investigative Site | Bloomington | Indiana | United States | 47403 |
| 24 | Investigative Site | Newton | Kansas | United States | 67114 |
| 25 | Investigative Site | Overland Park | Kansas | United States | 66215 |
| 26 | Investigative Site | Marrero | Louisiana | United States | 70072 |
| 27 | Investigative Site | Baltimore | Maryland | United States | 21230 |
| 28 | Investigative Site | Ann Arbor | Michigan | United States | 48106 |
| 29 | Investigative Site | Bingham Farms | Michigan | United States | 48025 |
| 30 | Investigative Site | Grand Rapids | Michigan | United States | 49506 |
| 31 | Investigative Site | Paw Paw | Michigan | United States | 49079 |
| 32 | Investigative Site | St. Clair Shores | Michigan | United States | 48081 |
| 33 | Investigative Site | Kansas City | Missouri | United States | 64114 |
| 34 | Investigative Site | Missoula | Montana | United States | 59808 |
| 35 | Investigative Site | McCook | Nebraska | United States | 69001 |
| 36 | Investigative Site | Las Vegas | Nevada | United States | 89128 |
| 37 | Investigative Site | Lawrenceville | New Jersey | United States | 08648 |
| 38 | Investigative Site | Moorestown | New Jersey | United States | 08057 |
| 39 | Investigative Site | New Brunswick | New Jersey | United States | 08903 |
| 40 | Investigative Site | Albuquerque | New Mexico | United States | 87131 |
| 41 | Investigative Site | New York | New York | United States | 10017 |
| 42 | Investigative Site | Rochester | New York | United States | 14621 |
| 43 | Investigative Site | Durham | North Carolina | United States | 27713 |
| 44 | Investigative Site | Raleigh | North Carolina | United States | 27607 |
| 45 | Investigative Site | Winston-Salem | North Carolina | United States | 27103 |
| 46 | Investigative Site | Bismarck | North Dakota | United States | 58501 |
| 47 | Investigative Site | Cleveland | Ohio | United States | 44121 |
| 48 | Investigative Site | Cleveland | Ohio | United States | 44122 |
| 49 | Investigative Site | Gallipolis | Ohio | United States | 45631 |
| 50 | Investigative Site | Zanesville | Ohio | United States | 43701 |
| 51 | Investigative Site | Oklahoma City | Oklahoma | United States | 73104 |
| 52 | Investigative Site | Oklahoma City | Oklahoma | United States | 73112 |
| 53 | Investigative Site | Eugene | Oregon | United States | 97401 |
| 54 | Investigative Site | Portland | Oregon | United States | 97205 |
| 55 | Investigative Site | Levittown | Pennsylvania | United States | 19056 |
| 56 | Investigative Site | Philadelphia | Pennsylvania | United States | 19104 |
| 57 | Investigative Site | Philadelphia | Pennsylvania | United States | 19114 |
| 58 | Investigative Site | Phoenixville | Pennsylvania | United States | 19460 |
| 59 | Investigative Site | Strafford | Pennsylvania | United States | 19087 |
| 60 | Investigative Site | Wexford | Pennsylvania | United States | 15090 |
| 61 | Investigative Site | Wynnewood | Pennsylvania | United States | 19096 |
| 62 | Investigative Site | Greenville | South Carolina | United States | 29605 |
| 63 | Investigative Site | Sioux Falls | South Dakota | United States | 57104 |
| 64 | Investigative Site | Bristol | Tennessee | United States | 37620 |
| 65 | Investigative Site | Clarksville | Tennessee | United States | 37043 |
| 66 | Investigative Site | Nashville | Tennessee | United States | 37203 |
| 67 | Investigative Site | Austin | Texas | United States | 78737 |
| 68 | Investigative Site | Bryan | Texas | United States | 77802 |
| 69 | Investigative Site | Fort Worth | Texas | United States | 76132 |
| 70 | Investigative Site | Houston | Texas | United States | 77030 |
| 71 | Investigative Site | Plano | Texas | United States | 75093 |
| 72 | Investigative Site | Temple | Texas | United States | 46502 |
| 73 | Investigative Site | Waco | Texas | United States | 76712 |
| 74 | Investigative Site | Webster | Texas | United States | 77598 |
| 75 | Investigative Site | Woodlands | Texas | United States | 77380 |
| 76 | Investigative Site | Pleasant Grove | Utah | United States | 84062 |
| 77 | Investigative Site | Salt Lake City | Utah | United States | 84124 |
| 78 | Investigative Site | West Jordan | Utah | United States | 84088 |
| 79 | Investigative Site | West Valley City | Utah | United States | 84120 |
| 80 | Investigative Site | Burlington | Vermont | United States | 05401 |
| 81 | Investigative Site | Norfolk | Virginia | United States | 23502 |
| 82 | Investigative Site | Richmond | Virginia | United States | 23225 |
| 83 | Investigative Site | Renton | Washington | United States | 98055 |
Sponsors and Collaborators
- Ferring Pharmaceuticals
Investigators
- Study Director: Clinical Development Support, Ferring Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00401193
Other Study ID Numbers:
- XP12B-MR-301
First Posted:
Nov 20, 2006
Last Update Posted:
May 13, 2015
Last Verified:
Apr 1, 2015
Keywords provided by Ferring Pharmaceuticals
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | 3900 mg/Day | 1950 mg/Day | Placebo |
|---|---|---|---|
| Arm/Group Description | Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation | One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation | Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation |
| Period Title: Overall Study | |||
| STARTED | 118 | 117 | 69 |
| Intent to Treat Population | 115 | 115 | 67 |
| Modified Intent to Treat Population | 112 | 115 | 67 |
| COMPLETED | 103 | 106 | 63 |
| NOT COMPLETED | 15 | 11 | 6 |
Baseline Characteristics
| Arm/Group Title | 3900 mg/Day | 1950 mg/Day | Placebo | Total |
|---|---|---|---|---|
| Arm/Group Description | Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation | One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation | Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation | Total of all reporting groups |
| Overall Participants | 115 | 115 | 67 | 297 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
39
(6)
|
40
(6)
|
39
(6)
|
39
(6)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
115
100%
|
115
100%
|
67
100%
|
297
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Mean Reduction From Baseline in Menstrual Blood Loss (MBL) |
|---|---|
| Description | reduction of menstrual blood loss in mL |
| Time Frame | Baseline MBL over 3 menstrual cycles |
Outcome Measure Data
| Analysis Population Description |
|---|
| modified intent to treat population |
| Arm/Group Title | 3900 mg/Day | 1950 mg/Day | Placebo |
|---|---|---|---|
| Arm/Group Description | Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation | One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation | Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation |
| Measure Participants | 112 | 115 | 67 |
| Least Squares Mean (Standard Deviation) [mL] |
65
(51)
|
44
(57)
|
7
(46)
|
| Title | Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding |
|---|---|
| Description | 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 |
| Time Frame | Baseline scores over 3 menstrual cycles |
Outcome Measure Data
| Analysis Population Description |
|---|
| modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis) |
| Arm/Group Title | 3900 mg/Day | Placebo |
|---|---|---|
| Arm/Group Description | Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation | Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation |
| Measure Participants | 112 | 66 |
| Least Squares Mean (Standard Deviation) [units on a scale] |
1.0
(1.1)
|
0.4
(0.8)
|
| Title | Patient Reported Outome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding |
|---|---|
| Description | 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 |
| Time Frame | Baseline scores over 3 menstrual cycles |
Outcome Measure Data
| Analysis Population Description |
|---|
| modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis) |
| Arm/Group Title | 3900 mg/Day | Placebo |
|---|---|---|
| Arm/Group Description | Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation | Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation |
| Measure Participants | 112 | 66 |
| Least Squares Mean (Standard Deviation) [units on a scale] |
0.9
(1.0)
|
0.3
(0.8)
|
| Title | Responder Analysis - Reduction in Large Stains |
|---|---|
| Description | Percentage of subjects who experienced a reduction from baseline in the frequency of large stains |
| Time Frame | Baseline over 3 mentrual cycles |
Outcome Measure Data
| Analysis Population Description |
|---|
| modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis) |
| Arm/Group Title | 3900 mg/Day | Placebo |
|---|---|---|
| Arm/Group Description | Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation | Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation |
| Measure Participants | 111 | 67 |
| Number [percentage of participants] |
64
55.7%
|
52
45.2%
|
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | 3900 mg/Day | 1950 mg/Day | Placebo | |||
| Arm/Group Description | Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation | One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation | Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation | |||
All Cause Mortality |
||||||
| 3900 mg/Day | 1950 mg/Day | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| 3900 mg/Day | 1950 mg/Day | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/115 (0.9%) | 1/115 (0.9%) | 0/67 (0%) | |||
| Gastrointestinal disorders | ||||||
| Dyspepsia | 1/115 (0.9%) | 0/115 (0%) | 0/67 (0%) | |||
| Gastritis | 1/115 (0.9%) | 0/115 (0%) | 0/67 (0%) | |||
| General disorders | ||||||
| Chest Pain | 1/115 (0.9%) | 0/115 (0%) | 0/67 (0%) | |||
| Reproductive system and breast disorders | ||||||
| Ovarian Torsion | 0/115 (0%) | 1/115 (0.9%) | 0/67 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| 3900 mg/Day | 1950 mg/Day | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 97/115 (84.3%) | 104/115 (90.4%) | 56/67 (83.6%) | |||
| Blood and lymphatic system disorders | ||||||
| Anemia | 1/115 (0.9%) | 6/115 (5.2%) | 1/67 (1.5%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal Pain | 23/115 (20%) | 24/115 (20.9%) | 15/67 (22.4%) | |||
| General disorders | ||||||
| Fatigue | 4/115 (3.5%) | 13/115 (11.3%) | 3/67 (4.5%) | |||
| Immune system disorders | ||||||
| Nasal & Sinus Symptoms | 16/115 (13.9%) | 35/115 (30.4%) | 7/67 (10.4%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 5/115 (4.3%) | 7/115 (6.1%) | 1/67 (1.5%) | |||
| Back Pain | 20/115 (17.4%) | 20/115 (17.4%) | 7/67 (10.4%) | |||
| Muscle Cramps & Spasms | 6/115 (5.2%) | 3/115 (2.6%) | 3/67 (4.5%) | |||
| Musculoskeletal Pain | 13/115 (11.3%) | 15/115 (13%) | 2/67 (3%) | |||
| Nervous system disorders | ||||||
| Headache | 48/115 (41.7%) | 54/115 (47%) | 26/67 (38.8%) | |||
| Migraine | 7/115 (6.1%) | 7/115 (6.1%) | 4/67 (6%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Clinical Development Support |
|---|---|
| Organization | Ferring Pharmaceuticals |
| Phone | |
| DK0-Disclosure@ferring.com |
Responsible Party:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00401193
Other Study ID Numbers:
- XP12B-MR-301
First Posted:
Nov 20, 2006
Last Update Posted:
May 13, 2015
Last Verified:
Apr 1, 2015