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Comparing Bioavailability When Preservative-free Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) is Administered as an Intramuscular Manual Injection or as a Subcutaneous Injection Using an Auto-injector in Healthy Post-menopausal Women

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ClinicalTrials.gov Identifier: NCT02940522
Recruitment Status : Completed
First Posted : October 21, 2016
Results First Posted : November 30, 2018
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE October 17, 2016
First Posted Date  ICMJE October 21, 2016
Results First Submitted Date  ICMJE April 24, 2018
Results First Posted Date  ICMJE November 30, 2018
Last Update Posted Date November 30, 2018
Actual Study Start Date  ICMJE September 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2018)
  • Comparison of Areas Under the Curve (AUC) to the Last Time With a Concentration ≥ LLOQ [AUC0-t] and to Infinity [AUCinf] [ Time Frame: 9 weeks ]
    Comparison of areas under the curve (AUC) to the last time with a concentration ≥ LLOQ [AUC0-t] and to infinity [AUCinf] for the Primary PK Population
  • Comparison of the Maximum Plasma Concentration (Cmax) [ Time Frame: 9 weeks ]
    Comparison of the maximum plasma concentration (Cmax) for the Primary PK Population
Original Primary Outcome Measures  ICMJE
 (submitted: October 19, 2016)
  • Comparison of the Maximum Plasma Concentration (Cmax) [ Time Frame: 8 weeks ]
    Comparison of the maximum plasma concentration (Cmax)
  • Comparison of Areas Under the Curve (AUC) to the Last Time With a Concentration ≥ LLOQ [AUC0-t] and to Infinity [AUCinf] [ Time Frame: 8 weeks ]
    Comparison of areas under the curve (AUC) to the last time with a concentration ≥ LLOQ [AUC0-t] and to infinity [AUCinf]
Change History Complete list of historical versions of study NCT02940522 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2018)
  • Comparison of Tmax [ Time Frame: 9 weeks ]
    Comparison of PK parameter Tmax for the Primary PK population
  • Comparison of AUC (0-168) [ Time Frame: 9 weeks ]
    Comparison of PK Parameter AUC (0-168) for the Primary PK Population
  • Comparison of t1/2 [ Time Frame: 9 weeks ]
    Comparison of PK parameter t1/2 for the Primary PK Population
  • Comparison of Elimination Rate Constant [ Time Frame: 9 weeks ]
    Comparison of the elimination rate constant for the Primary PK Population
Original Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2016)
  • Comparison of Tmax [ Time Frame: 8 weeks ]
    Comparison of PK parameter Tmax
  • Comparison of AUC [ Time Frame: 8 weeks ]
    Comparison of PK parameter AUC
  • Comparison of t1/2 [ Time Frame: 8 weeks ]
    Comparison of PK parameter t1/2
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Bioavailability When Preservative-free Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) is Administered as an Intramuscular Manual Injection or as a Subcutaneous Injection Using an Auto-injector in Healthy Post-menopausal Women
Official Title  ICMJE A Multi-Center, Randomized, Open-Label Study Comparing Bioavailability When Preservative-free Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) is Administered as an Intramuscular Manual Injection or as a Subcutaneous Injection Using an Auto-injector in Healthy Post-menopausal Women
Brief Summary To demonstrate that a single dose of Makena® delivered SQ via auto-injector has comparable bioavailability to a single IM injection of Makena®.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Comparing Bioavailability When Makena® is Administered in Healthy Post-menopausal Women
Intervention  ICMJE
  • Drug: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)
    Other Name: Makena SQ
  • Drug: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)
    Other Name: Makena
Study Arms  ICMJE
  • Experimental: Treatment A
    Subcutaneous (SQ) injection using an autoinjector
    Intervention: Drug: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)
  • Active Comparator: Treatment B
    Intramuscular injection (IM) using syringe and needle
    Intervention: Drug: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)
Publications * Krop J, Kramer WG. Comparative Bioavailability of Hydroxyprogesterone Caproate Administered via Intramuscular Injection or Subcutaneous Autoinjector in Healthy Postmenopausal Women: A Randomized, Parallel Group, Open-label Study. Clin Ther. 2017 Dec;39(12):2345-2354. doi: 10.1016/j.clinthera.2017.10.020. Epub 2017 Nov 27.

*   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: January 11, 2017)
122
Original Estimated Enrollment  ICMJE
 (submitted: October 19, 2016)
120
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

1. Naturally or surgically postmenopausal women, with or without an intact uterus, aged 50 to 75 years of age, inclusive. FSH levels greater than 40 mIU/mL

Exclusion Criteria:

  1. Currently taking any estrogen/progesterone hormone replacement therapy (HRT).
  2. History of allergy or sensitivity to hydroxyprogesterone caproate, castor oil or any of the constituents of the study medications, or history of any drug hypersensitivity or intolerance
  3. Poorly controlled diabetes.
  4. History or current evidence of deep vein thrombosis, pulmonary embolism or arterial thromboembolic disease (e.g., stroke, myocardial infarction).
  5. Known, suspected, or current history of carcinoma of the breast.
  6. Subjects with a past history of breast cancer on aromatase inhibitors or selective estrogen receptor modulators.
  7. Known, suspected, or current history of hormone dependent tumor within the last 5 years.
  8. Any current or recent (within previous 12 months) genital bleeding of unknown etiology.
  9. Receipt of any investigational drug within 30 days.
  10. Receipt of any prescription or OTC medications that are known to alter CYP3A4 or CYP3A5 levels (e.g., carbamazepine, St. John's Wort, ketoconazole, rifampin, ritonavir, alprazolam, azithromycin, loratadine, etc.) within 14.
  11. Any estrogen, progestin, or selective estrogen receptor modulator (SERM) treatment within specified time windows before the study start, ranging from 2 to 6 months.
  12. High blood pressure at the screening evaluation, defined as systolic blood pressure > 150 mm Hg or diastolic blood pressure > 90 mm Hg.
  13. History of excessive alcohol consumption (on average more than 14 units of alcohol/week) during the past 12 months.
  14. Use of tobacco products within 30 days of the start of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT02940522
Other Study ID Numbers  ICMJE AMAG-HPC-PK-010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party AMAG Pharmaceuticals, Inc.
Study Sponsor  ICMJE AMAG Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Julie Krop, MD AMAG Pharmaceuticals, Inc.
PRS Account AMAG Pharmaceuticals, Inc.
Verification Date April 2018

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