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Trial record 50 of 419 for:    TRANEXAMIC ACID

A Study of Tranexamic Acid (XP12B) in Women With Heavy Menstrual Bleeding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01280981
Recruitment Status : Completed
First Posted : January 21, 2011
Results First Posted : July 26, 2011
Last Update Posted : July 26, 2011
Sponsor:
Collaborator:
Xanodyne Pharmaceuticals
Information provided by:
Ferring Pharmaceuticals

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Menorrhagia
Intervention Drug: Tranexamic acid
Enrollment 288
Recruitment Details Participants who completed double-blind therapy in either study XP12B-MR-301 (NCT00401193) or XP12B-MR-303 (NCT00386308) could participate in this trial.
Pre-assignment Details  
Arm/Group Title Tranexamic Acid
Hide Arm/Group Description Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
Period Title: Overall Study
Started 288
Intent to Treat (ITT) Population 260 [1]
Completed 196
Not Completed 92
Reason Not Completed
Withdrawal by Subject             11
Protocol Violation             2
Lack of Efficacy             13
Lost to Follow-up             3
Adverse Event             6
Irregular or discontinued menses             3
Failed to return             45
Non-compliance with protocol             3
Withdrawal of consent             3
Elective surgery             2
Study site closure             1
[1]
Participants who took drug during at least one menstrual cycle
Arm/Group Title Tranexamic Acid
Hide Arm/Group Description Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
Overall Number of Baseline Participants 288
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 288 participants
<=18 years
0
   0.0%
Between 18 and 65 years
288
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 288 participants
Female
288
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Participants With Treatment-Emergent Adverse Events (AEs)
Hide Description Count of participants with treatment-emergent adverse events grouped in categories regarding relationship to study drug as assessed by the investigator, serious or life-threatening as assessed by the investigator, participants who died or their event led to withdrawal from study, and participants who experienced thrombotic or thromboembolic AEs.
Time Frame Day 1 to up to Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population (ITT)
Arm/Group Title Tranexamic Acid
Hide Arm/Group Description:
Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
Overall Number of Participants Analyzed 260
Measure Type: Number
Unit of Measure: participants
Any treatment-emergent AE 218
Definitely related AE 1
Probably related AE 3
Possibly related AE 60
Serious AE 5
Life-threatening AE 2
Died 0
AE led to withdrawal from study 6
Thrombotic or thromboembolic AE 0
2.Secondary Outcome
Title Participants With Abnormal Gynecological Examinations
Hide Description Participants with abnormal gynecological examination findings based on endometrial biopsies and transvaginal ultraonogrphy (TVU) are summarized. Clinically significant results from the endometrial biopsies are results that are not benign. Abnormalities found during transvaginal ultrasonography (TVU) are detailed in the AE listings. Please refer to AE listings.
Time Frame Day 1 to up to Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title Tranexamic Acid
Hide Arm/Group Description:
Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
Overall Number of Participants Analyzed 260
Measure Type: Number
Unit of Measure: participants
Significant results from endometrial biopsies 0
Abnormalities noted on TVU 3
Discontinued due to failed physical exam 0
3.Secondary Outcome
Title Mean Blood Pressure Measurements at Week 36
Hide Description Mean systolic and diastolic blood pressure measurements taken at week 36
Time Frame approximately week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population of participants with week 36 blood pressure data.
Arm/Group Title Tranexamic Acid
Hide Arm/Group Description:
Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
Overall Number of Participants Analyzed 200
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic blood pressure 118.94  (14.272)
Diastolic blood pressure 75.09  (10.167)
4.Secondary Outcome
Title Participants With Treatment Emergent Adverse Experiences (TEAE) of Laboratory Values Related to Treatment
Hide Description Participants whose laboratory examinations (hematology, blood chemistry and urinalysis) were considered by the investigator to be treatment emergent adverse experiences (TEAE) and related to treatment. Also indicated is whether the TEAE lab parameter caused the participant to discontinue from the study.
Time Frame Day 1 to up to Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title Tranexamic Acid
Hide Arm/Group Description:
Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
Overall Number of Participants Analyzed 260
Measure Type: Number
Unit of Measure: participants
Hematology TEAE related to study drug 1
Discontinued due to hematology TEAE 1
Blood chemistry TEAE related to study drug 1
Discontinued due to blood chemistry TEAE 0
Urinalysis TEAE related to study drug 2
Discontinued due to urinalysis TEAE 0
5.Secondary Outcome
Title Mean Intraocular Pressure at Month 9
Hide Description Mean intraocular pressure at month 9 or the early termination visit.
Time Frame Day 1 up to Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat participants who had ophthalmic exams.
Arm/Group Title Tranexamic Acid
Hide Arm/Group Description:
Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
Overall Number of Participants Analyzed 199
Mean (Standard Deviation)
Unit of Measure: mmHg
Right eye 15.4  (2.866)
Left eye 15.3  (2.797)
6.Secondary Outcome
Title Mean Fridericia-corrected QT Interval (QTcFRI) at Month 9
Hide Description The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization
Time Frame Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat participants who had an electrocardiogram (ECG) at month 9
Arm/Group Title Tranexamic Acid
Hide Arm/Group Description:
Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
Overall Number of Participants Analyzed 193
Mean (Standard Deviation)
Unit of Measure: milliseconds
412.3  (15.896)
Time Frame Treatment-emergent AEs: day 1 up to month 9
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tranexamic Acid
Hide Arm/Group Description Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
All-Cause Mortality
Tranexamic Acid
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tranexamic Acid
Affected / at Risk (%)
Total   5/260 (1.92%) 
Investigations   
Blood glucose decreased  1  1/260 (0.38%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Carcinoid tumour of the stomach  1  1/260 (0.38%) 
Nervous system disorders   
Brain stem infarction  1  1/260 (0.38%) 
Intracranial aneurysm  1  1/260 (0.38%) 
Trigeminal neuralgia  1  1/260 (0.38%) 
Reproductive system and breast disorders   
Menorrhagia  1  2/260 (0.77%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (7.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tranexamic Acid
Affected / at Risk (%)
Total   218/260 (83.85%) 
Blood and lymphatic system disorders   
Anaemia  1  10/260 (3.85%) 
Ear and labyrinth disorders   
Ear congestion  1  1/260 (0.38%) 
Ear discomfort  1  1/260 (0.38%) 
Ear pain  1  4/260 (1.54%) 
Ear pruritus  1  1/260 (0.38%) 
Tympanic membrane disorder  1  1/260 (0.38%) 
Vertigo  1  3/260 (1.15%) 
Endocrine disorders   
Hypothyroidism  1  1/260 (0.38%) 
Eye disorders   
Chalazion  1  1/260 (0.38%) 
Conjunctivitis  1  1/260 (0.38%) 
Corneal pigmentation  1  1/260 (0.38%) 
Dry eye  1  1/260 (0.38%) 
Eye discharge  1  1/260 (0.38%) 
Eye irritation  1  1/260 (0.38%) 
Ocular hypertension  1  1/260 (0.38%) 
Retinal artery stenosis  1  1/260 (0.38%) 
Retinal pigmentation  1  1/260 (0.38%) 
Vision blurred  1  2/260 (0.77%) 
Gastrointestinal disorders   
Abdominal discomfort  1  15/260 (5.77%) 
Abdominal pain  1  12/260 (4.62%) 
Abdominal pain lower  1  1/260 (0.38%) 
Abdominal pain upper  1  15/260 (5.77%) 
Anal polyp  1  3/260 (1.15%) 
Chapped lips  1  1/260 (0.38%) 
Constipation  1  9/260 (3.46%) 
Diarrhoea  1  19/260 (7.31%) 
Dry mouth  1  1/260 (0.38%) 
Dyspepsia  1  9/260 (3.46%) 
Flatulence  1  2/260 (0.77%) 
Food poisoning  1  1/260 (0.38%) 
Gastritis  1  1/260 (0.38%) 
Gastrooesophageal reflux disease  1  4/260 (1.54%) 
Gingival pain  1  1/260 (0.38%) 
Gingival swelling  1  1/260 (0.38%) 
Lip blister  1  1/260 (0.38%) 
Loose stools  1  1/260 (0.38%) 
Nausea  1  17/260 (6.54%) 
Oesophagitis  1  1/260 (0.38%) 
Tongue disorder  1  1/260 (0.38%) 
Toothache  1  11/260 (4.23%) 
Vomiting  1  6/260 (2.31%) 
General disorders   
Chest discomfort  1  1/260 (0.38%) 
Chest pain  1  1/260 (0.38%) 
Chills  1  4/260 (1.54%) 
Cyst  1  1/260 (0.38%) 
Fatigue  1  14/260 (5.38%) 
Influenza like illness  1  15/260 (5.77%) 
Localized oedema  1  1/260 (0.38%) 
Oedema  1  2/260 (0.77%) 
Pyrexia  1  4/260 (1.54%) 
Swelling  1  2/260 (0.77%) 
Hepatobiliary disorders   
Cholecystitis  1  1/260 (0.38%) 
Immune system disorders   
Multiple allergies  1  13/260 (5.00%) 
Seasonal allergies  1  9/260 (3.46%) 
Infections and infestations   
Acute sinusitis  1  1/260 (0.38%) 
Bronchitis  1  5/260 (1.92%) 
Cystitis  1  3/260 (1.15%) 
Ear infection  1  1/260 (0.38%) 
Herpes simplex  1  1/260 (0.38%) 
Herpes zoster  1  1/260 (0.38%) 
Influenza  1  4/260 (1.54%) 
Kidney infection  1  1/260 (0.38%) 
Laryngitis  1  2/260 (0.77%) 
Onychomycosis  1  1/260 (0.38%) 
Otitis media  1  1/260 (0.38%) 
Pharyngitis streptococcal  1  2/260 (0.77%) 
Pneumonia  1  1/260 (0.38%) 
Recurring skin boils  1  1/260 (0.38%) 
Rhinitis  1  4/260 (1.54%) 
Salpingitis  1  1/260 (0.38%) 
Sinusitis  1  22/260 (8.46%) 
Tonsillitis  1  1/260 (0.38%) 
Tooth abscess  1  1/260 (0.38%) 
Tooth infection  1  3/260 (1.15%) 
Upper respiratory tract infection  1  9/260 (3.46%) 
Urinary tract infection  1  8/260 (3.08%) 
Vaginal candidiasis  1  5/260 (1.92%) 
Viral upper respiratory tract infection  1  31/260 (11.92%) 
Vulvovaginitis trichomonal  1  2/260 (0.77%) 
Injury, poisoning and procedural complications   
Arthropod sting  1  1/260 (0.38%) 
Back injury  1  1/260 (0.38%) 
Foot fracture  1  1/260 (0.38%) 
Joint injury  1  4/260 (1.54%) 
Joint sprain  1  1/260 (0.38%) 
Muscle strain  1  2/260 (0.77%) 
Post procedural complication  1  1/260 (0.38%) 
Post procedural discomfort  1  2/260 (0.77%) 
Post procedural pain  1  7/260 (2.69%) 
Investigations   
Aspartate aminotransferase increased  1  1/260 (0.38%) 
Biopsy breast  1  1/260 (0.38%) 
Blood cholesterol increased  1  1/260 (0.38%) 
Blood glucose increased  1  1/260 (0.38%) 
Blood triglycerides increased  1  1/260 (0.38%) 
Blood urine present  1  2/260 (0.77%) 
Cardiac murmur  1  1/260 (0.38%) 
Electrocardiogram T wave abnormal  1  1/260 (0.38%) 
Faecal occult blood  1  1/260 (0.38%) 
Gamma-glutamyltransferase increased  1  2/260 (0.77%) 
Haematocrit decreased  1  3/260 (1.15%) 
Haemoglobin decreased  1  4/260 (1.54%) 
Human papilloma virus serology test negative  1  1/260 (0.38%) 
Human papilloma virus serology test positive  1  1/260 (0.38%) 
Lipids increased  1  2/260 (0.77%) 
Lymph node palpable  1  1/260 (0.38%) 
Mean cell haemoglobin decreased  1  1/260 (0.38%) 
Monocyte count decreased  1  1/260 (0.38%) 
Red blood cell count decreased  1  1/260 (0.38%) 
Serum ferritin decreased  1  2/260 (0.77%) 
Smear cervix abnormal  1  7/260 (2.69%) 
Thyroxine increased  1  1/260 (0.38%) 
Ultrasound uterus  1  2/260 (0.77%) 
Urinary occult blood positive  1  2/260 (0.77%) 
Weight increased  1  1/260 (0.38%) 
Metabolism and nutrition disorders   
Decreased appetite  1  1/260 (0.38%) 
Insulin resistance  1  2/260 (0.77%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  15/260 (5.77%) 
Arthritis  1  1/260 (0.38%) 
Back pain  1  60/260 (23.08%) 
Buttock pain  1  1/260 (0.38%) 
Flank pain  1  1/260 (0.38%) 
Groin pain  1  1/260 (0.38%) 
Joint stiffness  1  1/260 (0.38%) 
Muscle cramp  1  11/260 (4.23%) 
Muscular weakness  1  1/260 (0.38%) 
Musculoskeletal discomfort  1  2/260 (0.77%) 
Musculoskeletal pain  1  15/260 (5.77%) 
Myalgia  1  7/260 (2.69%) 
Neck pain  1  13/260 (5.00%) 
Pain in extremity  1  20/260 (7.69%) 
Pain in jaw  1  2/260 (0.77%) 
Plantar fasciitis  1  2/260 (0.77%) 
Tendonitis  1  1/260 (0.38%) 
Nervous system disorders   
Dizziness  1  3/260 (1.15%) 
Headache  1  114/260 (43.85%) 
Migraine  1  20/260 (7.69%) 
Paraesthesia  1  3/260 (1.15%) 
Restless leg syndrome  1  2/260 (0.77%) 
Sedation  1  2/260 (0.77%) 
Sinus headache  1  17/260 (6.54%) 
Tension headache  1  2/260 (0.77%) 
Psychiatric disorders   
Anxiety  1  7/260 (2.69%) 
Attention deficit/hyperactivity disorder  1  1/260 (0.38%) 
Depressed mood  1  1/260 (0.38%) 
Depression  1  9/260 (3.46%) 
Insomnia  1  11/260 (4.23%) 
Irritability  1  4/260 (1.54%) 
Mood swings  1  4/260 (1.54%) 
Stress symptoms  1  3/260 (1.15%) 
Renal and urinary disorders   
Bladder pain  1  1/260 (0.38%) 
Cystitis interstitial  1  1/260 (0.38%) 
Dysuria  1  1/260 (0.38%) 
Polyuria  1  1/260 (0.38%) 
Reproductive system and breast disorders   
Adenomyosis  1  1/260 (0.38%) 
Breast cyst  1  2/260 (0.77%) 
Breast discharge  1  1/260 (0.38%) 
Breast discomfort  1  1/260 (0.38%) 
Breast mass  1  1/260 (0.38%) 
Breast pain  1  1/260 (0.38%) 
Breast tenderness  1  5/260 (1.92%) 
Cervical polyp  1  1/260 (0.38%) 
Dysmenorrhoea  1  5/260 (1.92%) 
Fibrocystic breast disease  1  1/260 (0.38%) 
Menometrorrhagia  1  1/260 (0.38%) 
Menstrual discomfort  1  3/260 (1.15%) 
Menstrual disorder  1  1/260 (0.38%) 
Nipple pain  1  1/260 (0.38%) 
Ovarian cyst  1  1/260 (0.38%) 
Ovarian cyst ruptured  1  1/260 (0.38%) 
Ovulation pain  1  1/260 (0.38%) 
Paraesthesia of genital female  1  8/260 (3.08%) 
Pelvic pain  1  2/260 (0.77%) 
Premenstrual syndrome  1  2/260 (0.77%) 
Pruritus genital  1  6/260 (2.31%) 
Uterine enlargement  1  1/260 (0.38%) 
Uterine leiomyoma  1  1/260 (0.38%) 
Uterine pain  1  1/260 (0.38%) 
Vaginal discharge  1  7/260 (2.69%) 
Vaginal odour  1  1/260 (0.38%) 
Respiratory, thoracic and mediastinal disorders   
Allergic sinusitis  1  1/260 (0.38%) 
Asthma  1  4/260 (1.54%) 
Asthma exercise induced  1  1/260 (0.38%) 
Cough  1  12/260 (4.62%) 
Dry throat  1  2/260 (0.77%) 
Dyspnoea  1  3/260 (1.15%) 
Hoarseness  1  1/260 (0.38%) 
Nasal congestion  1  9/260 (3.46%) 
Postnasal drip  1  1/260 (0.38%) 
Respiratory tract congestion  1  2/260 (0.77%) 
Rhinitis allergic  1  1/260 (0.38%) 
Rhinorrhoea  1  1/260 (0.38%) 
Sinus congestion  1  16/260 (6.15%) 
Sinus pain  1  3/260 (1.15%) 
Sneezing  1  2/260 (0.77%) 
Throat irritation  1  6/260 (2.31%) 
Throat tightness  1  2/260 (0.77%) 
Skin and subcutaneous tissue disorders   
Acne  1  3/260 (1.15%) 
Cold sweat  1  1/260 (0.38%) 
Dermatitis contact  1  2/260 (0.77%) 
Dry skin  1  2/260 (0.77%) 
Ecchymosis  1  1/260 (0.38%) 
Lichenification  1  1/260 (0.38%) 
Rash  1  3/260 (1.15%) 
Urticaria  1  1/260 (0.38%) 
Surgical and medical procedures   
Benign breast lump removal  1  1/260 (0.38%) 
Meniscus operation  1  1/260 (0.38%) 
Surgery  1  1/260 (0.38%) 
Vascular disorders   
Flushing  1  1/260 (0.38%) 
Hypertension  1  3/260 (1.15%) 
Hypotension  1  1/260 (0.38%) 
Varicose vein  1  1/260 (0.38%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (7.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Development Support
Organization: Ferring Pharmaceuticals
EMail: DK0-Disclosure@ferring.com
Layout table for additonal information
Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01280981     History of Changes
Other Study ID Numbers: XP12B-MR-304
First Submitted: January 19, 2011
First Posted: January 21, 2011
Results First Submitted: May 3, 2011
Results First Posted: July 26, 2011
Last Update Posted: July 26, 2011