Clinical Trial: A Study of Tranexamic Acid (XP12B) in Women With Heavy Menstrual Bleeding
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 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.
Original Primary Outcome: Participants with Adverse Events [ Time Frame: Day 1 to up to Month 9 ]
Current Secondary Outcome:
- 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
Original Secondary Outcome:
- Participants with Abnormal Physical and Gynecological Examinations [ Time Frame: Day 1 to up to Month 9 ]
- Participants with Abnormal Vital Sign Measurements [ Time Frame: Day 1 to up to Month 9 ]
- Participants with Abnormal Laboratory Determinations (Hematology, Blood Chemistry, and Urinalysis) [ Time Frame: Day 1 to up to Month 9 ]
- Participants with Abnormal Ophthalmologic examinations [ Time Frame: Day 1 to up to Month 9 ]
- Participants with Abnormal 12-lead Electrocardiograms (ECGs) [ Time Frame: Day 1 to up to Month 9 ]
Information By: Ferring Pharmaceuticals
Dates:
Date Received: January 19, 2011
Date Started: April 2007
Date Completion:
Last Updated: June 28, 2011
Last Verified: June 2011
