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

NCT02937766 | Terminated Phase 3 Results

• 1 other identifier: AMAG-HPC-HPM-301
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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®

Conditions

Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) in Healthy Post-menopausal Women

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Clinician Assessment of Ease of Injection Technique

  4 weeks

• Clinician Assessment of Ease of Drug Preparation

  4 weeks

Study Arms (2)

Treatment A

EXPERIMENTAL

Subcutaneous (SQ) injection using an autoinjector weekly over 4 weeks (4 injections)

Drug: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)

Treatment B

ACTIVE COMPARATOR

Intramuscular injection (IM) using syringe and needle weekly over 4 weeks (4 injections)

Drug: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)

Interventions

Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) DRUG

Also known as: Makena SQ

Treatment A

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Have history of or positive test results for HIV or hepatitis B or C.
• A significant history or current evidence of chronic infectious disease, organ dysfunction especially cardiovascular, renal, or hepatic disorders or other medical condition.
• Receiving or have received chronic opioid therapy within 12 months.
• 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.
• 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.
• Currently taking any estrogen/progesterone hormone replacement therapy (HRT).
• 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.
• Poorly controlled diabetes (Hgb A1C \>8).
• Current or history of thrombosis or thromboembolic disorders.
• Known or suspected breast cancer, other hormone-sensitive cancer or tumor, or history of these conditions within the last 5 years.
• Any current or recent (within previous 12 months) vaginal bleeding.
• Uncontrolled hypertension.
• A chronic pain condition (i.e. chronic back pain) that may confound the assessments of injection pain.

Sponsors & Collaborators

• AMAG Pharmaceuticals, Inc.: lead

Study Sites (1)

Lotus Clinical Research, LLC

Pasadena, California, 91105, United States

Location

MeSH Terms

Interventions

17 alpha-Hydroxyprogesterone Caproate

Intervention Hierarchy (Ancestors)

17-alpha-Hydroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Progesterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Limitations and Caveats

The Sponsor elected to discontinue the study prematurely due to business reasons. The only parameters analyzed for efficacy were Ease of Drug Preparation and Ease of Injection Technique.

Results Point of Contact

• Title: Medical Information
• Organization: AMAG Pharmaceuticals, Inc.

CTInterest@covispharma.com

Study Officials

• Neil Singla, MD

  Lotus Clinical Research, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 19, 2016
• Study Start: October 7, 2016
• Primary Completion: January 6, 2017
• Study Completion: March 27, 2017
• Last Updated: April 21, 2022
• Results First Posted: December 12, 2018

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)