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NCT01428713 · ClinicalTrials.gov registry record · NA
Tranexamic Acid (TA) vs Combined Oral Contraceptive (COCP) Pilot Study
A NA study of Menorrhagia, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT01428713 is a NA study of Menorrhagia that has completed, run by Baylor College of Medicine. The registered enrollment target is 17 participants, below the 227-participant average among 10 other Menorrhagia trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01428713, a NA study of Menorrhagia, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG Oral tranexamic acid
- DRUG Oral Contraceptive Pills
Study Locations (1)
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2011-08 |
| Est. Completion | 2013-06 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01428713
The ClinicalTrials.gov registry entry for NCT01428713 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 227-participant average among 10 other Menorrhagia trials with a reported enrollment target (93% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Menorrhagia appearing as the primary indexed condition, and to 2 interventions - of which Oral tranexamic acid is the first listed.
NCT01428713 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT01428713 about?
NCT01428713 is a clinical study titled "Tranexamic Acid (TA) vs Combined Oral Contraceptive (COCP) 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 me...
What is the current status of trial NCT01428713?
This trial is currently completed. It is a NA study. The enrollment target is 17 participants. The study started on 2011-08. Estimated completion is 2013-06.
What conditions does trial NCT01428713 study?
This clinical trial studies the following conditions: Menorrhagia.
What interventions are being tested in trial NCT01428713?
The interventions under investigation include: Oral tranexamic acid (DRUG), Oral Contraceptive Pills (DRUG).
Who is sponsoring clinical trial NCT01428713?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01428713 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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