A Study of Tranexamic Acid (XP12B) in Women With Heavy Menstrual Bleeding
This was a multicenter, open-label extension study for subjects completing either of 2 pivotal efficacy studies (NCT00401193 or NCT00386308). The study consisted of a treatment phase of 9 menstrual periods to assess the safety of 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. After the last treatment period, a follow-up phone call occurred approximately 30 days (range 25 to 35 days) after the last dose of study drug.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Participants With Treatment-Emergent Adverse Events (AEs) [ Time Frame: Day 1 to up to Month 9 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]Mean intraocular pressure at month 9 or the early termination visit.
- Mean Fridericia-corrected QT Interval (QTcFRI) at Month 9 [ Time Frame: Month 9 ] [ Designated as safety issue: Yes ]The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization
|Study Start Date:||April 2007|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
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.
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|Study Director:||Clinical Development Support||Ferring Pharmaceuticals|