Tranexamic Acid (TA) vs Combined Oral Contraceptive (COCP) Pilot Study

Launched by BAYLOR COLLEGE OF MEDICINE · Sep 1, 2011

Keywords

ClinConnect Summary

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.

Group B received combined oral contraceptive pills (OCP) with 3 weeks of hormonal pills and 1 week of placebo for 3 cycles.

After 3 cycles of therapy, both groups had one cycle without any therapy. Then, the groups crossed over. Group A, who first received TA, then received OCP. Group B, who first received OCP, then received TA.

All subjects were to receive both tranexamic acid and oral co...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. PBAC Score greater than 100 for 2 consecutive cycles
• • 3. Pelvic ultrasound that excludes pelvic pathology that can cause menorrhagia within 12 months prior to study participation.
• • 4. Normal external genitalia examination within 6 months prior to study participation.
• • 5. Normal thyroid stimulating hormone (TSH) in the last 6 months prior to study participation.
• • 6. Negative urine or serum pregnancy test within 4 weeks prior to study participation.
• Exclusion Criteria:
• • 1. Presence of intra uterine device.
• • 2. 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.
• • 3. Intake of medications with increased risk of bleeding
• • 4. Taking herbal products.
• • 5. Sexually active status.
• • 6. Body weight less than 40 kg.