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

NCT01428713 | Completed Results DMC

• 1 other identifier: H-27934 TA vs COCP Study
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Menorrhagia

Keywords

menorrhagia; oral contraceptives; oral tranexamic acid

Outcome Measures

Primary Outcomes (1)

• To Assess the Efficacy of Oral TA and COCP in Adolescents With Menorrhagia.

  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

  Baseline, 3 cycles

Study Arms (2)

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.

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.

Drug: Oral Contraceptive Pills

Interventions

Oral tranexamic acid DRUG

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 A-Oral tranexamic acid

Oral Contraceptive Pills DRUG

Group B received combined oral contraceptive pills with 3 weeks of hormonal pills and 1 week of placebo for 3 cycles.

Group B-Combined oral contraceptive pills

Eligibility Criteria

• Age: Up to 21 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Menorrhagia

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Dr. Lakshmi Srivaths
• Organization: Baylor College of Medicine/TCH

lvsrivat@txch.org

832-822-1514

Study Officials

• Lakshmi Srivaths, MD

  Baylor College of Medicine/TCH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 1, 2011
• First Posted: September 5, 2011
• Study Start: August 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 10, 2016
• Results First Posted: September 17, 2014

Record last verified: 2016-08

Locations

US (1)