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

Ferring Pharmaceuticals89 sites in 1 country288 target enrollmentApril 2007

ConditionsMenorrhagia

InterventionsTranexamic acid

DrugsTranexamic acid

Overview

Phase: Phase 3
Intervention: Tranexamic acid
Conditions: Menorrhagia
Sponsor: Ferring Pharmaceuticals
Enrollment: 288
Locations: 89
Primary Endpoint: Participants With Treatment-Emergent Adverse Events (AEs)
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 2007

End Date

May 2009

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Ferring Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

•The study enrolled subjects who had completed the double-blind therapy in either the XP12B-MR-301 or XP12B-MR-303 study, including scheduled evaluations, with no major protocol violations and no study events that, in the opinion of the investigator, would preclude the subject's entry into the open-label safety study.
•A negative urine pregnancy test was required immediately before entry into this study.
•Women must have been surgically sterile or, if of childbearing potential, must have been in a monogamous relationship with a sterile partner or a partner of the same sex.
•Women must have used an acceptable barrier contraception method with spermicide for the duration of the study or must have been using a copper intrauterine device (IUD).
•In the opinion of the investigator, the subject must be able to understand this study, cooperate with all study procedures, be able to return to the study site for visits within the required visit windows and be deemed likely to complete the study.
•Subject will provide voluntary, written consent to participate in the study by signing and dating an institutional review board (IRB)-approved informed consent before any procedures are performed or study drug is dispensed.

Exclusion Criteria

•History or presence of clinically significant hepatic or renal disease or other medical disease that might confound the study or be detrimental to the subject (e.g., clinically significant cardiac arrhythmia, uncontrolled diabetes or uncontrolled hypertension) as determined by the investigator.
•Normal gynecological examination and breast examination.
•Clinically significant abnormalities on screening physical examination that might confound the study or be detrimental to the subject as assessed by the investigator. Abnormal clinically significant electrocardiograms (ECG) as determined by the centralized cardiologist, or laboratory tests suggestive of a potential pituitary-prolactin stimulating tumor (prolactin \>=30 µg/L), thrombocytopenia (platelet count \<100,000/mm3), uncontrolled hypothyroidism (TSH \>=10 mU/L) or severe anemia (hemoglobin \<8 g/dL\]).
•Anovulatory dysfunctional uterine bleeding, metrorrhagia (irregular or frequent noncyclic flow), menometrorrhagia (irregular or frequent excessive noncyclic flow) or polymenorrhea (frequent flow, cycles of less than 21 days).
•History or presence of endometrial polyps, endometrial hyperplasia, endometrial carcinoma or cervical carcinoma (includes cervical carcinoma in situ).
•History of bilateral oophorectomy or hysterectomy.
•Women who are pregnant, breastfeeding, planning to become pregnant during the study or become pregnant during the study.
•History or active presence of myocardial infarction or ischemic disease. History or active presence of cerebrovascular accident, stroke, or transient ischemic attack.
•History or presence of thrombosis, thromboembolic disease or coagulopathy including, but not limited to, pulmonary embolism, deep venous thrombosis, phlebitis and any intravascular clotting disorder.
•History or known presence of acquired or inherited thrombophilia, including, but not limited to, antithrombin deficiency, Protein C and/or S deficiency, antiphospholipid deficiency, Factor V Leiden mutation and prothrombin mutation. Thalassemia or sickle cell disease (sickle cell trait individuals are not excluded).

Arms & Interventions

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).

Intervention: Tranexamic acid

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Participants With Abnormal Gynecological Examinations(Day 1 to up to Month 9)
Mean Blood Pressure Measurements at Week 36(approximately week 36)
Participants With Treatment Emergent Adverse Experiences (TEAE) of Laboratory Values Related to Treatment(Day 1 to up to Month 9)
Mean Intraocular Pressure at Month 9(Day 1 up to Month 9)
Mean Fridericia-corrected QT Interval (QTcFRI) at Month 9(Month 9)