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

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

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®

Study Overview

• Status: Terminated
• Conditions: Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) in Healthy Post-menopausal Women
• Intervention / Treatment: Drug: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Pasadena, California, United States, 91105
      • Lotus Clinical Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Makena
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 Names: Makena

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Average Pain Intensity	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)	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician Assessment of Ease of Injection Technique	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	4 weeks
Clinician Assessment of Ease of Drug Preparation	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	4 weeks

Collaborators and Investigators

• Sponsor: AMAG Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2016
• Primary Completion (Actual): January 6, 2017
• Study Completion (Actual): March 27, 2017

Study Registration Dates

• First Submitted: October 17, 2016
• First Submitted That Met QC Criteria: October 18, 2016
• First Posted (Estimate): October 19, 2016

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: March 31, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Estrogen Antagonists; Progestins; 17 alpha-Hydroxyprogesterone Caproate; 11-hydroxyprogesterone
• Other Study ID Numbers: AMAG-HPC-HPM-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No