Tranexamic Acid (TA) vs Combined Oral Contraceptive (COCP) Pilot Study
Primary Purpose
Menorrhagia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oral tranexamic acid
Oral Contraceptive Pills
Sponsored by
About this trial
This is an interventional treatment trial for Menorrhagia focused on measuring menorrhagia, oral contraceptives, oral tranexamic acid
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Baylor College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A-Oral tranexamic acid
Group B-Combined oral contraceptive pills
Arm Description
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 with 3 weeks of hormonal pills and 1 week of placebo for 3 cycles.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01428713
First Posted
September 1, 2011
Last Updated
August 8, 2016
Sponsor
Baylor College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01428713
Brief Title
Tranexamic Acid (TA) vs Combined Oral Contraceptive (COCP) Pilot Study
Official Title
Prospective Crossover Trial of Oral Tranexamic Acid and Combined Oral Contraceptive in Adolescents With Menorrhagia - A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
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.
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:
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
Quality of Life evaluation - by the patient completing a standardized pediatric quality of life (PedsQL) questionnaire
Detailed history and physical examination to evaluate for drug side effects and to look for signs of blood clots.
Blood drawn for a complete blood count.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menorrhagia
Keywords
menorrhagia, oral contraceptives, oral tranexamic acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A-Oral tranexamic acid
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group B-Combined oral contraceptive pills
Arm Type
Active Comparator
Arm Description
Group B received combined oral contraceptive pills with 3 weeks of hormonal pills and 1 week of placebo for 3 cycles.
Intervention Type
Drug
Intervention Name(s)
Oral tranexamic acid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Oral Contraceptive Pills
Intervention Description
Group B received combined oral contraceptive pills with 3 weeks of hormonal pills and 1 week of placebo for 3 cycles.
Primary Outcome Measure Information:
Title
To Assess the Efficacy of Oral TA and COCP in Adolescents With Menorrhagia.
Description
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
Time Frame
Baseline, 3 cycles
10. Eligibility
Sex
Female
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lakshmi Srivaths, MD
Organizational Affiliation
Baylor College of Medicine/TCH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
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Tranexamic Acid (TA) vs Combined Oral Contraceptive (COCP) Pilot Study
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