Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 17 of 730 for:    Area Under Curve AND Bioavailability

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

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®.

Condition or disease Intervention/treatment Phase
Comparing Bioavailability When Makena® is Administered in Healthy Post-menopausal Women Drug: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arm Intervention/treatment
Experimental: Treatment A
Subcutaneous (SQ) injection using an autoinjector
Drug: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)
Other Name: Makena SQ

Active Comparator: Treatment B
Intramuscular injection (IM) using syringe and needle
Drug: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)
Other Name: Makena




Primary Outcome Measures :
  1. 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

  2. Comparison of the Maximum Plasma Concentration (Cmax) [ Time Frame: 9 weeks ]
    Comparison of the maximum plasma concentration (Cmax) for the Primary PK Population


Secondary Outcome Measures :
  1. Comparison of Tmax [ Time Frame: 9 weeks ]
    Comparison of PK parameter Tmax for the Primary PK population

  2. Comparison of AUC (0-168) [ Time Frame: 9 weeks ]
    Comparison of PK Parameter AUC (0-168) for the Primary PK Population

  3. Comparison of t1/2 [ Time Frame: 9 weeks ]
    Comparison of PK parameter t1/2 for the Primary PK Population

  4. Comparison of Elimination Rate Constant [ Time Frame: 9 weeks ]
    Comparison of the elimination rate constant for the Primary PK Population



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02940522


Locations
Layout table for location information
United States, California
Anaheim, California, United States, 92801
United States, Florida
DeLand, Florida, United States, 32720
Miami, Florida, United States, 33143
Orlando, Florida, United States, 32809
United States, Texas
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
AMAG Pharmaceuticals, Inc.
Investigators
Layout table for investigator information
Study Chair: Julie Krop, MD AMAG Pharmaceuticals, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02940522     History of Changes
Other Study ID Numbers: AMAG-HPC-PK-010
First Posted: October 21, 2016    Key Record Dates
Results First Posted: November 30, 2018
Last Update Posted: November 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
17 alpha-Hydroxyprogesterone Caproate
11-hydroxyprogesterone
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Progestins
Hormones