A Study of Tranexamic Acid (XP12B) in Women With Heavy Menstrual Bleeding
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|ClinicalTrials.gov Identifier: NCT01280981|
Recruitment Status : Completed
First Posted : January 21, 2011
Results First Posted : July 26, 2011
Last Update Posted : July 26, 2011
|Condition or disease||Intervention/treatment||Phase|
|Menorrhagia||Drug: Tranexamic acid||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||288 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-center, Open Label Extension Study to Evaluate the Safety of an Oral Dose of Tranexamic Acid (XP12B) Administered Three Times Daily During Menstruation for the Treatment of Menorrhagia|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
Experimental: Tranexamic acid
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).
Drug: Tranexamic acid
Tranexamic acid at an oral dose of 1.3 g administered 3 times per day for up to 5 days (maximum of 15 doses) during menstruation for 9 menstrual periods.
- Participants With Treatment-Emergent Adverse Events (AEs) [ Time Frame: Day 1 to up to Month 9 ]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.
- Participants With Abnormal Gynecological Examinations [ Time Frame: Day 1 to up to Month 9 ]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.
- Mean Blood Pressure Measurements at Week 36 [ Time Frame: approximately week 36 ]Mean systolic and diastolic blood pressure measurements taken at week 36
- Participants With Treatment Emergent Adverse Experiences (TEAE) of Laboratory Values Related to Treatment [ Time Frame: Day 1 to up to Month 9 ]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.
- Mean Intraocular Pressure at Month 9 [ Time Frame: Day 1 up to Month 9 ]Mean intraocular pressure at month 9 or the early termination visit.
- Mean Fridericia-corrected QT Interval (QTcFRI) at Month 9 [ Time Frame: Month 9 ]The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01280981
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|Study Director:||Clinical Development Support||Ferring Pharmaceuticals|