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Trial record 29 of 36 for:    AMINOCAPROIC ACID

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

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ClinicalTrials.gov Identifier: NCT01428713
Recruitment Status : Completed
First Posted : September 5, 2011
Results First Posted : September 17, 2014
Last Update Posted : August 10, 2016
Sponsor:
Collaborator:
Texas Children's Hospital
Information provided by (Responsible Party):
Lakshmi Srivaths, Baylor College of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Menorrhagia
Interventions Drug: Oral tranexamic acid
Drug: Oral Contraceptive Pills
Enrollment 17
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Group A: TA First, Then COCP Group B: COCP First, Then TA
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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.

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.

Period Title: Overall Study
Started 9 8
Completed 6 3
Not Completed 3 5
Reason Not Completed
Non-compliance             2             2
Withdrawal by Subject             1             1
Adverse Event             0             2
Arm/Group Title All Study Participants
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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.

Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
17 post-menarchal girls with menorrhagia or menometrorrhagia without underlying bleeding disorders, pelvic pathology, pelvic infection, thyroid abnormalities or pregnancy.
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants
14.2  (1.6)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
<=18 years
17
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
17
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants
17
1.Primary Outcome
Title To Assess the Efficacy of Oral TA and COCP in Adolescents With Menorrhagia.
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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

Time Frame Baseline, 3 cycles
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Hide Analysis Population Description
10 patients completed TA and their results were analyzed. 11 patients completed COCP and their results were analyzed.
Arm/Group Title Group: TA Group: COCP
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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.
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.
Overall Number of Participants Analyzed 10 11
Mean (Standard Error)
Unit of Measure: Scores on a scale
PBAC (Pictorial Blood Assessment Chart) score 536.4  (162.12) 430.6  (157.35)
Peds QL (Pediatric Quality of Life) score 15.6  (5.08) 16.75  (4.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group: TA
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments P value < 0.05 is considered significant in this study
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 536.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 162.12
Estimation Comments Comparing PBAC score value at baseline vs. end of 3 cycles for TA
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group: COCP
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments P value < 0.05 is considered significant for this study
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 430.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 157.35
Estimation Comments Comparing PBAC score value at baseline vs. end of 3 cycles for COCP
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group: TA
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments P value < 0.05 is considered significant for this study
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 15.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.08
Estimation Comments Comparing Peds QL score value at baseline vs. end of 3 cycles for TA
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group: COCP
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 16.75
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.87
Estimation Comments Comparing Peds QL score value at baseline vs. end of 3 cycles for COCP
Time Frame 8 months
Adverse Event Reporting Description 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.
 
Arm/Group Title Tranexamic Acid (TA) Combined Oral Contraceptives (COCP)
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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.

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.
All-Cause Mortality
Tranexamic Acid (TA) Combined Oral Contraceptives (COCP)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Tranexamic Acid (TA) Combined Oral Contraceptives (COCP)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/11 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tranexamic Acid (TA) Combined Oral Contraceptives (COCP)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/10 (20.00%)      8/11 (72.73%)    
General disorders     
nausea/vomiting *  1/10 (10.00%)  1 1/11 (9.09%)  1
abdominal pain *  0/10 (0.00%)  0 1/11 (9.09%)  1
headache *  0/10 (0.00%)  0 1/11 (9.09%)  1
weight gain *  0/10 (0.00%)  0 1/11 (9.09%)  1
mood swings *  0/10 (0.00%)  0 1/11 (9.09%)  1
depression and seizure * [1]  0/10 (0.00%)  0 1/11 (9.09%)  1
generalized rash *  0/10 (0.00%)  0 1/11 (9.09%)  1
Lack of sleep *  1/10 (10.00%)  1 0/11 (0.00%)  0
Reproductive system and breast disorders     
breakthrough bleeding *  1/10 (10.00%)  1 1/11 (9.09%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Depression and seizure already diagnosed prior to study.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Lakshmi Srivaths
Organization: Baylor College of Medicine/TCH
Phone: 832-822-1514
EMail: lvsrivat@txch.org
Layout table for additonal information
Responsible Party: Lakshmi Srivaths, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01428713     History of Changes
Other Study ID Numbers: H-27934 TA vs COCP Study
First Submitted: September 1, 2011
First Posted: September 5, 2011
Results First Submitted: June 9, 2014
Results First Posted: September 17, 2014
Last Update Posted: August 10, 2016