Lysteda Pediatric Research Equity Act (PREA) Pharmacokinetic Study in Adolescent Females With Heavy Menstrual Bleeding
NCT ID: NCT01190150
Last Updated: 2012-07-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2010-08-31
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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0.65 g / 1.3 g tranexamic acid
Participants received a single dose of 0.65 g tranexamic acid on Day 1 and a single dose of 1.3 g tranexamic acid on Day 8.
tranexamic acid
Either one or two modified-immediate release tranexamic acid tablets (0.65 g each) taken orally, administered with 240 mL of water, as a single dose, at approximately 8 AM.
1.3 g / 0.65 g tranexamic acid
Participants received a single dose of 1.3 g tranexamic acid on Day 1 and a single dose of 0.65 g tranexamic acid on Day 8.
tranexamic acid
Either one or two modified-immediate release tranexamic acid tablets (0.65 g each) taken orally, administered with 240 mL of water, as a single dose, at approximately 8 AM.
Interventions
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tranexamic acid
Either one or two modified-immediate release tranexamic acid tablets (0.65 g each) taken orally, administered with 240 mL of water, as a single dose, at approximately 8 AM.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects must report regularly occurring menstrual periods ≤10 days in duration, with 21-45 days from the start of one period to the start of the next menstrual period
* Diagnosis of HMB based on the medical judgment of the Principal Investigator and will include the following criteria:
1. Laboratory (including a bleeding disorders work-up) and Physical Findings;
2. Limitations in Activities of Daily Living (ADL);
3. Soiling, Staining and Clotting;
4. Sanitary product usage and extent of MBL using a patient reported pictorial blood assessment chart (PBAC).
* Subjects should either be sexually inactive (abstinent) or be using one of the following acceptable birth control methods and agree to continue its use throughout the study:
* copper intrauterine device (IUD) in place for at least 3 months;
* barrier methods (condom, diaphragm) with spermicide for at least 1 month prior to the first dose and throughout the study.
* Negative pregnancy test results
* Subject's legally authorized representative (e.g., parent, guardian) must voluntarily sign a parental permission/informed consent form (ICF), and the subject must sign an assent, before the conduct of any study procedure
Exclusion Criteria
* Known bleeding or coagulation disorders based on medical history and/or laboratory results
* Known systemic hematologic diseases (e.g., all types of sickle-cell disease, thalassemia of all types, multiple myeloma, hemolytic anemia)
* Clinical evidence of any significant chronic illness, including cardiovascular, renal, neurologic, hepatic, endocrine, gastric, central nervous system disease, any psychiatric illness which could affect the efficacy or safety of study medication
* Subjects treated with systemic steroids in the last 1 month or hormonal treatment in the last 3 months
* A history or presence of any drug abuse or alcohol abuse within the last 1 year
* History of subarachnoid hemorrhage.
* Active thromboembolic disease; history of thrombosis or thromboembolism, including retinal vein or artery occlusion; an intrinsic risk of thrombosis or thromboembolism
* Use of vaginal hormone products (rings, creams, and gels) within 4 weeks prior to screening. Use of oral estrogen-, progestin-, or selective estrogen receptor within 8 weeks prior to screening. Use of Lupron (3-month depot injection), estrogen pellet, or long-acting progestin injectables within 6 months prior to screening
* Subjects whose sitting blood pressure is less than 90/60 mmHg at screening
* Subjects whose pulse is lower than 50 b.p.m. at screening
* Subjects whose PR interval is \>200 msec at screening and prior to dosing
* Subjects whose QTc interval \>450 msec
* Subjects with positive tests for hepatitis B, C, or human immunodeficiency virus (HIV)
12 Years
16 Years
FEMALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Support
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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West Coast Clinical Trials
Cypress, California, United States
Countries
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Other Identifiers
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FE999304 CS01
Identifier Type: -
Identifier Source: org_study_id