MenorrhagiaNCT01428713
Tranexamic Acid (TA) vs Combined Oral Contraceptive (COCP) Pilot Study
A study testing Oral tranexamic acid and Oral Contraceptive Pills in people with Menorrhagia, run by Baylor College of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 21 years, women only
- Conditions the study is for
- Menorrhagia
- What is being tested?
- Oral tranexamic acid and Oral Contraceptive Pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Crossover Trial of Oral Tranexamic Acid and Combined Oral Contraceptive in Adolescents With Menorrhagia - A Pilot Study
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.
Read the 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.
- Conditions
- Menorrhagia
- Being tested
- Oral tranexamic acid, Oral Contraceptive Pills
- Keywords
- menorrhagia, oral contraceptives, oral tranexamic acid
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral tranexamic acidDrug
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 PillsDrug
Group B received combined oral contraceptive pills with 3 weeks of hormonal pills and 1 week of placebo for 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Group A-Oral tranexamic acid | Active comparator | 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. Receives: Drug: Oral tranexamic acid |
| Group B-Combined oral contraceptive pills | Active comparator | Group B received combined oral contraceptive pills with 3 weeks of hormonal pills and 1 week of placebo for 3 cycles. Receives: Drug: Oral Contraceptive Pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 3 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MenorrhagiaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lakshmi Srivaths, Baylor College of Medicine
- Investigators
- Lakshmi Srivaths, MD, Principal investigator, Baylor College of Medicine/TCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428713
- Sponsor's protocol ID
- H-27934 TA vs COCP Study
- Status last verified
- Aug 2016
- First submitted
- 1 Sep 2011
- Last updated
- 10 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Crossover Trial of Oral Tranexamic Acid and Combined Oral Contraceptive in Adolescents With Menorrhagia - A Pilot Study
- ClinicalTrials.gov ID
- NCT01428713
- Acronym / sponsor ID
- H-27934 TA vs COCP Study
- Conditions
- Menorrhagia
- Keywords
- menorrhagia, oral contraceptives, oral tranexamic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 5 Sep 2011 (estimated)
- Results
- Posted 17 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A-Oral tranexamic acid | Active comparator | Drug: Oral tranexamic acidGroup 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-Combined oral contraceptive pills | Active comparator | Drug: Oral Contraceptive PillsGroup B received combined oral contraceptive pills with 3 weeks of hormonal pills and 1 week of placebo for 3 cycles. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral tranexamic acidGroup 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. | Drug | Group A-Oral tranexamic acid |
| Oral Contraceptive PillsGroup B received combined oral contraceptive pills with 3 weeks of hormonal pills and 1 week of placebo for 3 cycles. | Drug | Group B-Combined oral contraceptive pills |
Primary outcome
To Assess the Efficacy of Oral TA and COCP in Adolescents With Menorrhagia.
Time frame: Baseline, 3 cycles
To assess 1. change in Pictorial Blood Assessment Chart Score (PBAC Score) from baseline to the end of 3 cycles of TA 2. change in quality of life (QOL) as evaluated by the PedsQL instrument from baseline to the end of 3 cycles of TA 3. change in Pictorial Blood Assessment Chart Score (PBAC Score) from baseline to the end of 3 cycles of COCP 4. 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lakshmi Srivaths, MD principal investigator
Baylor College of Medicine/TCH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral tranexamic acid and Oral Contraceptive Pills in people with Menorrhagia, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Assess the Efficacy of Oral TA and COCP in Adolescents With Menorrhagia. (time frame: Baseline, 3 cycles). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2016.