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Lysteda Pediatric Research Equity Act (PREA) Pharmacokinetic Study in Adolescent Females With Heavy Menstrual Bleeding (PREA)

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ClinicalTrials.gov Identifier: NCT01190150
Recruitment Status : Completed
First Posted : August 27, 2010
Results First Posted : July 3, 2012
Last Update Posted : July 16, 2012
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE August 26, 2010
First Posted Date  ICMJE August 27, 2010
Results First Submitted Date  ICMJE May 30, 2012
Results First Posted Date  ICMJE July 3, 2012
Last Update Posted Date July 16, 2012
Study Start Date  ICMJE August 2010
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2012)
  • Maximum Concentrations Level (Cmax) [ Time Frame: Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose) ]
    Cmax is the maximum measured plasma concentration over the time-span specified.
  • Dose-normalized Maximum Concentrations Level (Cmax) [ Time Frame: Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose) ]
    Cmax is the maximum measured plasma concentration over the time-span specified and normalized to the 1.3 g dose.
  • Time to Maximum Concentration Level (Tmax) [ Time Frame: Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose) ]
    Time of the maximum measured plasma concentration. If the maximum value occurs at more than one time point, Tmax is defined as the first time point with this value.
  • Area Under the Concentration Versus Time Curve From 0 to the Last Time Point (AUC0-t) [ Time Frame: Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose) ]
    The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration, as calculated by the linear trapezoidal method.
  • Dose Normalized Area Under the Concentration Versus Time Curve From 0 to the Last Time Point (AUC0-t) [ Time Frame: Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose) ]
    The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration normalized to the 1.3 g dose.
  • Area Under the Concentration Versus Time Curve From 0 to Infinity (AUCinf) [ Time Frame: Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose) ]
    The area under the plasma concentration versus time curve from time 0 to infinity. AUCinf is calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.
  • Dose Normalized Area Under the Concentration Versus Time Curve From 0 to Infinity (AUCinf) [ Time Frame: Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose) ]
    Dose-normalized AUCinf is calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant, normalized to the 1.3 g dose.
  • The Ratio of AUC0-t to AUCinf [ Time Frame: Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose) ]
    Comparison of AUC0-t to AUCinf by creating a ratio.
  • Elimination Half-life (t ½) [ Time Frame: Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose) ]
    Apparent first-order terminal elimination half life
Original Primary Outcome Measures  ICMJE
 (submitted: August 26, 2010)
  • PK parameters describing the pharmacokinetic profile of a single dose of 0.65 g and 1.3 g Lysteda [ Time Frame: 48 hours (two 24 hour periods) starting on Day 1 and ending on Day 2 and again starting on Day 8 and ending on Day 9 ]
  • Assessment of the dose-proportionality [ Time Frame: 48 hours (two 24 hour periods) starting on Day 1 and ending on Day 2 and again starting on Day 8 and ending on Day 9 ]
Change History Complete list of historical versions of study NCT01190150 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2012)
Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Day 1 up to week 4 ]
Treatment-emergent AEs are summarized by total participants with TEAEs, participants with serious TEAEs, participants with TEAEs deemed by the investigator to be related to treatment, and participants who experienced TEAEs that caused permanent discontinuation from the study.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2010)
  • Safety evaluations based on the discontinuations due to AEs [ Time Frame: 4 weeks - duration of study participation ]
  • Number of incidences and severity of treatment-emergent adverse events reported [ Time Frame: 4 weeks - duration of study participation ]
  • Safety evaluations based on changes from screening to last assessment (post-study) in physical examinations [ Time Frame: 4 weeks - duration of study participation ]
  • Safety evaluations based on static 12-lead ECGs [ Time Frame: 4 weeks - duration of study participation ]
  • Safety evaluations based on vital signs, and clinical laboratory tests, including hematology, blood chemistry, and urinalysis [ Time Frame: 4 weeks - duration of study participation ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lysteda Pediatric Research Equity Act (PREA) Pharmacokinetic Study in Adolescent Females With Heavy Menstrual Bleeding
Official Title  ICMJE Randomized, 2-way Crossover, Pharmacokinetic Study of Lysteda (Xanodyne Modified-Immediate Release Tranexamic Acid) Tablets at 2 Doses in Fasting Adolescent Females With Evidence of Heavy Menstrual Bleeding
Brief Summary This is a Phase 4, randomized, 2-way crossover, pharmacokinetic study of Lysteda (tranexamic acid) tablets administered as single doses of 0.65 g and 1.3 g in fasting adolescent female subjects ages 12-16 years with heavy menstrual bleeding.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Menorrhagia
Intervention  ICMJE Drug: 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 Names:
  • Lysteda
  • modified-immediate release tranexamic acid
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: tranexamic acid
  • Experimental: 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.
    Intervention: Drug: tranexamic acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 26, 2010)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Generally healthy non-smoking (for at least 3 months) adolescent females 12-16 years of age with a history of at least 1 year of cyclic heavy menstrual bleeding (HMB)
  • 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:

  • Breast-feeding, or a history of abortion in the last 6 months
  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 12 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01190150
Other Study ID Numbers  ICMJE FE999304 CS01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ferring Pharmaceuticals
Study Sponsor  ICMJE Ferring Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Development Support Ferring Pharmaceuticals
PRS Account Ferring Pharmaceuticals
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP