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

Menorrhagia Clinical Trial

Official title:

Prospective Crossover Trial of Oral Tranexamic Acid and Combined Oral Contraceptive in Adolescents With Menorrhagia - A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01428713
• Other study ID #: H-27934 TA vs COCP Study
• Status: Completed
• Phase: N/A
• First received: September 1, 2011
• Last updated: August 8, 2016
• Start date: August 2011
• Est. completion date: June 2013

Study information

• Verified date: August 2016
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

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 contraceptive pills.

There were a total of 3 study-associated visits per patient: 1 at baseline and 2 at the end of 3 cycles on each medication. These visits were considered within standard of care, as subjects with menorrhagia have frequent monitoring until the effectiveness of the treatment is determined.

At the study visits the following were done:

1. Assessment of the last menstrual period (amount of blood lost) using the Pictorial Blood Assessment Chart (PBAC) score and the number of days the period lasted

2. Quality of Life evaluation - by the patient completing a standardized pediatric quality of life (PedsQL) questionnaire

3. Detailed history and physical examination to evaluate for drug side effects and to look for signs of blood clots.

4. Blood drawn for a complete blood count.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 21 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menorrhagia

Intervention

Drug:
• Oral tranexamic acid
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.
• Oral Contraceptive Pills
Group B received combined oral contraceptive pills with 3 weeks of hormonal pills and 1 week of placebo for 3 cycles.

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	Texas Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Assess the Efficacy of Oral TA and COCP in Adolescents With Menorrhagia.	To assess; change in Pictorial Blood Assessment Chart Score (PBAC Score) from baseline to the end of 3 cycles of TA; change in quality of life (QOL) as evaluated by the PedsQL instrument from baseline to the end of 3 cycles of TA; change in Pictorial Blood Assessment Chart Score (PBAC Score) from baseline to the end of 3 cycles of COCP; change in quality of life (QOL) as evaluated by the PedsQL instrument from baseline to the end of 3 cycles of COCP; PBAC score: Quantitative score to measure menstrual blood loss. Scale range: Minimum - 0 score, Maximum: No maximum Interpretation: Score > 100 indicates heavy menstrual bleeding; Peds QL score: Score to measure quality of life in children Scale range: Minimum: 0, Maximum 100 Calculation: Subscales are reverse scored (using formula 100 - a x 25) and then all subscales are averaged Eg: Subscale score of 3 is reverse scored as: 100 - (3 x 25) = 25 Interpretation: Higher score indicates better quality of life	Baseline, 3 cycles	No