Trial Outcomes & Findings for Tranexamic Acid (TA) vs Combined Oral Contraceptive (COCP) Pilot Study (NCT NCT01428713)

Last Updated: 2016-08-10

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

17 participants

Primary outcome timeframe

Baseline, 3 cycles

Results posted on

2016-08-10

Participant Flow

Post-menarchal young girls \</= 21 years of age with menorrhagia or menometrorrhagia, referred to hematology or gynecology clinics at Texas Children's Hospital (TCH) formed the study population.

The study design employed was a randomized crossover trial comparing the use of oral TA formulation Lysteda and the COCP formulation Lo/Ovral. Patients were randomized to one of two treatment groups, group A versus group B. Patients who were already on COCP underwent one cycle washout prior to randomization.

Participant milestones

Participant milestones
Measure	Group A: TA First, Then COCP Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents \<18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles. Subsequently, patients who initially received TA, received COCP. COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles. Each medication was prescribed for 3 menstrual cycles with a 1 month wash out in-between TA and COCP.	Group B: COCP First, Then TA Patients received COCP first. COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles. Each medication was prescribed for 3 menstrual cycles with a 1 month wash out in-between COCP and TA. Subsequently, patients who initially received COCP, received TA. Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents \<18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles.
Overall Study STARTED	9	8
Overall Study COMPLETED	6	3
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Group A: TA First, Then COCP Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents \<18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles. Subsequently, patients who initially received TA, received COCP. COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles. Each medication was prescribed for 3 menstrual cycles with a 1 month wash out in-between TA and COCP.	Group B: COCP First, Then TA Patients received COCP first. COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles. Each medication was prescribed for 3 menstrual cycles with a 1 month wash out in-between COCP and TA. Subsequently, patients who initially received COCP, received TA. Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents \<18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles.
Overall Study Non-compliance	2	2
Overall Study Withdrawal by Subject	1	1
Overall Study Adverse Event	0	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=17 Participants Group A: TA first, then COCP: Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents \<18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles. Subsequently, patients who initially received TA, received COCP. Group B: COCP first, then TA: Patients received COCP first. COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles. Each medication was prescribed for 3 menstrual cycles with a 1 month wash out in-between TA and COCP. Subsequently, patients who initially received COCP, received TA.
Age, Continuous	14.2 years STANDARD_DEVIATION 1.6 • n=99 Participants
Age, Categorical <=18 years	17 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	17 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Region of Enrollment United States	17 participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline, 3 cycles

Population: 10 patients completed TA and their results were analyzed. 11 patients completed COCP and their results were analyzed.

Outcome measures

Outcome measures
Measure	Group: TA n=10 Participants Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents \<18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles.	Group: COCP n=11 Participants Patients received COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles.
To Assess the Efficacy of Oral TA and COCP in Adolescents With Menorrhagia. PBAC (Pictorial Blood Assessment Chart) score	536.4 Scores on a scale Standard Error 162.12	430.6 Scores on a scale Standard Error 157.35
To Assess the Efficacy of Oral TA and COCP in Adolescents With Menorrhagia. Peds QL (Pediatric Quality of Life) score	15.6 Scores on a scale Standard Error 5.08	16.75 Scores on a scale Standard Error 4.87

Adverse Events

Tranexamic Acid (TA)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Combined Oral Contraceptives (COCP)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Tranexamic Acid (TA) n=10 participants at risk Patients received oral tranexamic acid at 1300 mg three times each day on days 1 to 5 of menstrual cycle for 3 cycles. The mean age of the study population was 14.2 years. Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents \<18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles. Subsequently, patients who initially received TA, received COCP and patients who initially received COCP, then received TA.	Combined Oral Contraceptives (COCP) n=11 participants at risk COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles. Each medication was prescribed for 3 menstrual cycles with a 1 month wash out in-between medications.
Reproductive system and breast disorders breakthrough bleeding	10.0% 1/10 • Number of events 1 • 8 months Only patients that completed each intervention were considered at risk. 10 patients completed TA and their results were analyzed. 11 patients completed COCP and their results were analyzed.	9.1% 1/11 • Number of events 1 • 8 months Only patients that completed each intervention were considered at risk. 10 patients completed TA and their results were analyzed. 11 patients completed COCP and their results were analyzed.
General disorders nausea/vomiting	10.0% 1/10 • Number of events 1 • 8 months Only patients that completed each intervention were considered at risk. 10 patients completed TA and their results were analyzed. 11 patients completed COCP and their results were analyzed.	9.1% 1/11 • Number of events 1 • 8 months Only patients that completed each intervention were considered at risk. 10 patients completed TA and their results were analyzed. 11 patients completed COCP and their results were analyzed.
General disorders abdominal pain	0.00% 0/10 • 8 months Only patients that completed each intervention were considered at risk. 10 patients completed TA and their results were analyzed. 11 patients completed COCP and their results were analyzed.	9.1% 1/11 • Number of events 1 • 8 months Only patients that completed each intervention were considered at risk. 10 patients completed TA and their results were analyzed. 11 patients completed COCP and their results were analyzed.
General disorders headache	0.00% 0/10 • 8 months Only patients that completed each intervention were considered at risk. 10 patients completed TA and their results were analyzed. 11 patients completed COCP and their results were analyzed.	9.1% 1/11 • Number of events 1 • 8 months Only patients that completed each intervention were considered at risk. 10 patients completed TA and their results were analyzed. 11 patients completed COCP and their results were analyzed.
General disorders weight gain	0.00% 0/10 • 8 months Only patients that completed each intervention were considered at risk. 10 patients completed TA and their results were analyzed. 11 patients completed COCP and their results were analyzed.	9.1% 1/11 • Number of events 1 • 8 months Only patients that completed each intervention were considered at risk. 10 patients completed TA and their results were analyzed. 11 patients completed COCP and their results were analyzed.
General disorders mood swings	0.00% 0/10 • 8 months Only patients that completed each intervention were considered at risk. 10 patients completed TA and their results were analyzed. 11 patients completed COCP and their results were analyzed.	9.1% 1/11 • Number of events 1 • 8 months Only patients that completed each intervention were considered at risk. 10 patients completed TA and their results were analyzed. 11 patients completed COCP and their results were analyzed.
General disorders depression and seizure	0.00% 0/10 • 8 months Only patients that completed each intervention were considered at risk. 10 patients completed TA and their results were analyzed. 11 patients completed COCP and their results were analyzed.	9.1% 1/11 • Number of events 1 • 8 months Only patients that completed each intervention were considered at risk. 10 patients completed TA and their results were analyzed. 11 patients completed COCP and their results were analyzed.
General disorders generalized rash	0.00% 0/10 • 8 months Only patients that completed each intervention were considered at risk. 10 patients completed TA and their results were analyzed. 11 patients completed COCP and their results were analyzed.	9.1% 1/11 • Number of events 1 • 8 months Only patients that completed each intervention were considered at risk. 10 patients completed TA and their results were analyzed. 11 patients completed COCP and their results were analyzed.
General disorders Lack of sleep	10.0% 1/10 • Number of events 1 • 8 months Only patients that completed each intervention were considered at risk. 10 patients completed TA and their results were analyzed. 11 patients completed COCP and their results were analyzed.	0.00% 0/11 • 8 months Only patients that completed each intervention were considered at risk. 10 patients completed TA and their results were analyzed. 11 patients completed COCP and their results were analyzed.

Additional Information

Dr. Lakshmi Srivaths

Baylor College of Medicine/TCH

Phone: 832-822-1514

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place