Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) When Administered Via Subcutaneous Auto-injector vs Intramuscular Injection Via Needle and Syringe 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: NCT02937766
Recruitment Status : Terminated (The Sponsor elected to discontinue the study prematurely due to business reasons)
First Posted : October 19, 2016
Results First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.

Brief Summary:
To demonstrate that Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) delivered subcutaneously via auto-injector is associated with less pain as compared to intramuscular injections of Makena®

Condition or disease Intervention/treatment Phase
Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) in Healthy Post-menopausal Women Drug: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Single-Center, Open-labeled, Randomized Controlled Study Assessing Injection Pain of Preservative-free Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) When Administered Via Subcutaneous Auto-injector vs Intramuscular Injection Via Needle and Syringe in Healthy Post-menopausal Women
Actual Study Start Date : October 7, 2016
Actual Primary Completion Date : January 6, 2017
Actual Study Completion Date : March 27, 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 weekly over 4 weeks (4 injections)
Drug: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)
Other Name: Makena SQ

Active Comparator: Treatment B
Intramuscular injection (IM) using syringe and needle weekly over 4 weeks (4 injections)
Drug: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)
Other Name: Makena




Primary Outcome Measures :
  1. Comparison of Average Pain Intensity [ Time Frame: 4 weeks ]

    Comparison of average pain intensity associated with the administration of Makena® via subcutaneous autoinjector versus intramuscular injection (averaged over 4 visits).

    Score on a scale: 0 (No Pain) up to 10 (Worst Pain Imaginable)



Secondary Outcome Measures :
  1. Clinician Assessment of Ease of Injection Technique [ Time Frame: 4 weeks ]

    Investigate the clinician's assessment of the ease of injection technique associated with the administration of Makena® via subcutaneous auto-injector versus intramuscular injection as measured by a categorical scale.

    Scores were as follows: completely dissatisfied = -3; mostly dissatisfied = -2, somewhat dissatisfied = -1, neither satisfied nor unsatisfied = 0, somewhat satisfied = 1, mostly satisfied = 2, completely satisfied = 3


  2. Clinician Assessment of Ease of Drug Preparation [ Time Frame: 4 weeks ]

    Investigate the clinician's assessment of the ease of drug preparation associated with the administration of Makena® via subcutaneous auto-injector versus intramuscular injection as measured by a categorical scale.

    Scores were as follows: completely dissatisfied = -3; mostly dissatisfied = -2, somewhat dissatisfied = -1, neither satisfied nor unsatisfied = 0, somewhat satisfied = 1, mostly satisfied = 2, completely satisfied = 3




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. Female subjects aged 50 to 75 years of age, inclusive, at Screening Visit.
  2. Follicle stimulating hormone (FSH) levels greater than 40 mIU/mL.
  3. Naturally or surgically postmenopausal with or without an intact uterus.

Exclusion Criteria:

  1. Have history of or positive test results for HIV or hepatitis B or C.
  2. A significant history or current evidence of chronic infectious disease, organ dysfunction especially cardiovascular, renal, or hepatic disorders or other medical condition.
  3. Receiving or have received chronic opioid therapy within 12 months.
  4. Unwilling to stop taking/using:

    • pain medication.
    • topical analgesic or anti-inflammatory treatment. Topical analgesics must be washed out by at least 72 hours in the areas to be treated before randomization.
  5. History of alcohol abuse (regularly drinks > 4 units of alcohol per day; 8 oz. beer, 3 oz. wine, 1 oz. spirits) or prescription/illicit drug abuse in the last 12 months.
  6. Currently taking any estrogen/progesterone hormone replacement therapy (HRT).
  7. 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.
  8. Poorly controlled diabetes (Hgb A1C >8).
  9. Current or history of thrombosis or thromboembolic disorders.
  10. Known or suspected breast cancer, other hormone-sensitive cancer or tumor, or history of these conditions within the last 5 years.
  11. Any current or recent (within previous 12 months) vaginal bleeding.
  12. Uncontrolled hypertension.
  13. A chronic pain condition (i.e. chronic back pain) that may confound the assessments of injection pain.

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): NCT02937766


Locations
Layout table for location information
United States, California
Lotus Clinical Research, LLC
Pasadena, California, United States, 91105
Sponsors and Collaborators
AMAG Pharmaceuticals, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Neil Singla, MD Lotus Clinical Research, LLC

Layout table for additonal information
Responsible Party: AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02937766     History of Changes
Other Study ID Numbers: AMAG-HPC-HPM-301
First Posted: October 19, 2016    Key Record Dates
Results First Posted: December 12, 2018
Last Update Posted: December 12, 2018
Last Verified: November 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