Status:
COMPLETED
Tranexamic Acid (TA) vs Combined Oral Contraceptive (COCP) Pilot Study
Lead Sponsor:
Baylor College of Medicine
Conditions:
Menorrhagia
Eligibility:
FEMALE
Up to 21 years
Phase:
NA
Brief Summary
Menorrhagia, considered a public health challenge and reported by 5 to 10% of adult women, is encountered even more frequently in adolescents. Surveys of school students in the United States (US) and ...
Detailed Description
Subjects were randomized to one of two groups (group A or B). Group A received oral tranexamic acid at 1300 mg (two 650mg tablets), three times each day on days 1 to 5 of menstrual cycle for 3 cycles...
Eligibility Criteria
Inclusion
- Menstruating females with menorrhagia or menometrorrhagia referred to hematology or gynecology clinics at Texas Childrens Hospital. Menorrhagia is defined as regular periods with heavy menstrual bleeding with a PBAC score greater than 100; menometrorrhagia is heavy vaginal bleeding occurring at irregular intervals.
- PBAC Score greater than 100 for 2 consecutive cycles
- Pelvic ultrasound that excludes pelvic pathology that can cause menorrhagia within 12 months prior to study participation.
- Normal external genitalia examination within 6 months prior to study participation.
- Normal thyroid stimulating hormone (TSH) in the last 6 months prior to study participation.
- Negative urine or serum pregnancy test within 4 weeks prior to study participation.
Exclusion
- Presence of intra uterine device.
- Presence of a diagnosed bleeding disorder based on the standard work-up including complete blood count (CBC), prothrombin time, partial thromboplastin time, fibrinogen, von Willebrand panel and platelet function analysis (PFA-100) or platelet aggregation.
- Intake of medications with increased risk of bleeding
- Taking herbal products.
- Sexually active status.
- Body weight less than 40 kg.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01428713
Start Date
August 1 2011
End Date
June 1 2013
Last Update
August 10 2016
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030