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

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: Female

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 Europe reported menorrhagia in 37% to 55% of adolescent females. Medical management of adolescent menorrhagia includes various formulations of hormonal therapy and the antifibrinolytic agent epsilon aminocaproic acid. Oral tranexamic acid (TA), a more potent antifibrinolytic agent used as standard therapy for menorrhagia in adult women and in adolescent women in Europe and Canada, was not previously available in the US. Subsequent to US FDA approval in November 2009 of a novel oral TA formulation to treat cyclic heavy menstrual bleeding in adult women, this medication is currently included in the treatment armamentarium for adult menorrhagia. There is currently no preliminary data available in the US about the clinical use of oral TA in an exclusive adolescent population with menorrhagia. Oral contraceptive pills (OCP) are considered standard therapy in the management of menorrhagia in teen-aged women. Oral TA has been shown to be more efficacious than progesterone-only hormonal therapy for menorrhagia in adult women. However, there is no data available comparing the efficacy of oral TA and combined OCP (COCP) in adult women or in adolescents with menorrhagia.

The study hypothesis is that, in adolescent menorrhagia, oral TA will have comparable efficacy in reducing menstrual blood loss (MBL) and improving quality of life (QOL) when compared to the commonly prescribed COCP.

This hypothesis was tested by comparing the efficacy of these two medications, in a prospective randomized crossover trial in post-menarchal young girls with menorrhagia.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Collaborator: Texas Children's Hospital
• Treatments: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Tranexamic Acid

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.