Efficacy and Safety Study of XP12B in Women With Menorrhagia

• Sponsor: Ferring Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00386308
• Collaborator: (none)
• Enrollment: 196
• Locations: 52
• Arms: 2
• Duration (Months): 19
• Patients Per Site: 3.8
• Patients Per Site Per Month: 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
Menorrhagia; Heavy Menstrual Bleeding	Drug: Tranexamic acid tablets; Drug: Placebo tablets	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 196 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: Oct 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: Lysteda XP12B
Placebo Comparator: 2	Drug: Placebo tablets; Other Names: Lysteda XP12B

Outcome Measures

Primary Outcome Measures

1. Mean Reduction From Baseline in Menstrual Blood Loss (MBL) [Baseline MBL over 6 menstrual cycles]

   reduction of menstrual blood loss in mL

Secondary Outcome Measures

1. Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding [Change from Baseline scores over 6 menstrual cycles]

   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

2. Patient Reported Outcome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding [Change from Baseline scores over 6 menstrual cycles]

   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

3. Responder Analysis - Reduction in Large Stains [Reduction from Baseline over 6 menstrual 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigative Site	Tucson	Arizona	United States	85712
2	Investigative Site	Tucson	Arizona	United States	85741
3	Investigative Site	Little Rock	Arkansas	United States	72205
4	Investigative Site	Carmichael	California	United States	95608
5	Investigative Site	San Diego	California	United States	92123
6	Investigative Site	Upland	California	United States	91786
7	Investigative Site	Denver	Colorado	United States	80206
8	Investigative Site	Lakewood	Colorado	United States	80228
9	Investigative Site	Groton	Connecticut	United States	06340
10	Investigative Site	West Hartford	Connecticut	United States	06117
11	Investigative Site	Inverness	Florida	United States	34452
12	Investigative Site	Miami	Florida	United States	33133
13	Investigative Site	Miami	Florida	United States	33136
14	Investigative Site	Atlanta	Georgia	United States	30328
15	Investigative Site	Atlanta	Georgia	United States	30342
16	Investigative Site	Decatur	Georgia	United States	30033
17	Investigative Site	Savannah	Georgia	United States	31406
18	Investigative Site	Idaho Falls	Idaho	United States	83404
19	Investigative Site	Amite	Louisiana	United States	70422
20	Investigative Site	Baton Rouge	Louisiana	United States	70808
21	Investigative Site	Marrero	Louisiana	United States	70072
22	Investigative Site	Shreveport	Louisiana	United States	71115
23	Investigative Site	Paw Paw	Michigan	United States	49079
24	Investigative Site	Scottsbluff	Nebraska	United States	69361
25	Investigative Site	Lawrenceville	New Jersey	United States	08648
26	Investigative Site	Canfield	Ohio	United States	44406
27	Investigative Site	Centerville	Ohio	United States	45459
28	Investigative Site	Cleveland	Ohio	United States	44122
29	Investigative Site	Zanesville	Ohio	United States	43701
30	Investigative Site	Norman	Oklahoma	United States	73071
31	Investigative Site	Oklahoma City	Oklahoma	United States	73112
32	Investigative Site	Eugene	Oregon	United States	97401
33	Investigative Site	Medford	Oregon	United States	97504
34	Investigative Site	Portland	Oregon	United States	97210
35	Investigative Site	Salem	Oregon	United States	97301
36	Investigative Site	Abington	Pennsylvania	United States	19001
37	Investigative Site	Jenkintown	Pennsylvania	United States	19046
38	Investigative Site	Reading	Pennsylvania	United States	19606
39	Investigative Site	Charleston	South Carolina	United States	29401
40	Investigative Site	Columbia	South Carolina	United States	29201
41	Investigative Site	Greenville	South Carolina	United States	29615
42	Investigative Site	Greer	South Carolina	United States	29651
43	Investigative Site	Chattanooga	Tennessee	United States	37403
44	Investigative Site	Knoxville	Tennessee	United States	37920
45	Investigative Site	Memphis	Tennessee	United States	38119
46	Investigative Site	Dallas	Texas	United States	75235
47	Investigative Site	Houston	Texas	United States	77030
48	Investigative Site	Sandy	Utah	United States	84070
49	Investigative Site	Spokane	Washington	United States	99207
50	Investigative Site	Charleston	West Virginia	United States	25301
51	Investigative Site	Huntington	West Virginia	United States	25701
52	Investigative Site	Menomonee Falls	Wisconsin	United States	53051

Sponsors and Collaborators

• Ferring Pharmaceuticals

Investigators

• Study Director: Clinical Development Support, Ferring Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00386308
• Other Study ID Numbers: XP12B-MR-303
• First Posted: Oct 11, 2006
• Last Update Posted: May 4, 2011
• Last Verified: Jun 1, 2010

• Keywords provided by , ,: Heavy Menstrual Bleeding; Menorrhagia
• Additional relevant MeSH terms: Menorrhagia; Hemorrhage; Tranexamic Acid

Study Results

Participant Flow

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
Period Title: Overall Study
STARTED	123	73
Intent to Treat Population	117	72
Modified Intent to Treat Population	115	72
COMPLETED	94	54
NOT COMPLETED	29	19

Baseline Characteristics

Arm/Group Title	3900 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	Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation	Total of all reporting groups
Overall Participants	117	72	189
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39 (6)	39 (7)	39 (7)
Sex: Female, Male (Count of Participants)
Female	117 100%	72 100%	189 100%
Male	0 0%	0 0%	0 0%

Outcome Measures

1. Secondary Outcome

Title	Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding
Description	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
Time Frame	Change from Baseline scores over 6 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	115	72
Least Squares Mean (Standard Deviation) [units on a scale]	0.9 (0.8)	0.4 (0.4)

2. Secondary Outcome

Title	Patient Reported Outcome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding
Description	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
Time Frame	Change from Baseline scores over 6 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	115	72
Least Squares Mean (Standard Deviation) [units on a scale]	0.9 (0.9)	0.4 (0.9)

3. Secondary Outcome

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	Reduction from Baseline over 6 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	115	72
Number [percentage of subjects]	57	51

4. Primary Outcome

Title	Mean Reduction From Baseline in Menstrual Blood Loss (MBL)
Description	reduction of menstrual blood loss in mL
Time Frame	Baseline MBL over 6 menstrual cycles

Outcome Measure Data

Analysis Population Description

modified intent to treat population

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	115	72
Least Squares Mean (Standard Deviation) [mL]	66 (64)	18 (36)

Adverse Events

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
All Cause Mortality
	3900 mg/Day		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	3900 mg/Day		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/117 (1.7%)		3/72 (4.2%)
Cardiac disorders
Tachycardia	1/117 (0.9%)		0/72 (0%)
Infections and infestations
Acute Bronchitis	0/117 (0%)		1/72 (1.4%)
Investigations
Decreased Blood Sugar	1/117 (0.9%)		0/72 (0%)
Psychiatric disorders
Post-Traumatic Stress Disorder	0/117 (0%)		1/72 (1.4%)
Skin and subcutaneous tissue disorders
Urticaria	0/117 (0%)		1/72 (1.4%)
Vascular disorders
Deep Vein Thrombosis	0/117 (0%)		1/72 (1.4%)
Other (Not Including Serious) Adverse Events
	3900 mg/Day		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	111/117 (94.9%)		66/72 (91.7%)
Blood and lymphatic system disorders
Anemia	12/117 (10.3%)		4/72 (5.6%)
Gastrointestinal disorders
Abdominal Pain	23/117 (19.7%)		10/72 (13.9%)
General disorders
Fatigue	8/117 (6.8%)		3/72 (4.2%)
Musculoskeletal and connective tissue disorders
Arthralgia	11/117 (9.4%)		6/72 (8.3%)
Back Pain	28/117 (23.9%)		14/72 (19.4%)
Muscle Cramps & Spasms	9/117 (7.7%)		5/72 (6.9%)
Musculoskeletal Pain	13/117 (11.1%)		2/72 (2.8%)
Nervous system disorders
Headache	69/117 (59%)		39/72 (54.2%)
Migraine	7/117 (6%)		4/72 (5.6%)
Respiratory, thoracic and mediastinal disorders
Nasal & Sinus Symptoms	43/117 (36.8%)		17/72 (23.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.