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

NCT02940522 | Completed Phase 1 Results

• 1 other identifier: AMAG-HPC-PK-010
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 5

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®.

Conditions

Comparing Bioavailability When Makena® is Administered in Healthy Post-menopausal Women

Outcome Measures

Primary Outcomes (2)

• Comparison of Areas Under the Curve (AUC) to the Last Time With a Concentration ≥ LLOQ [AUC0-t] and to Infinity [AUCinf]

  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

  9 weeks

• Comparison of the Maximum Plasma Concentration (Cmax)

  Comparison of the maximum plasma concentration (Cmax) for the Primary PK Population

  9 weeks

Secondary Outcomes (4)

• Comparison of Tmax

  9 weeks

• Comparison of AUC (0-168)

  9 weeks

• Comparison of t1/2

  9 weeks

• Comparison of Elimination Rate Constant

  9 weeks

Study Arms (2)

Treatment A

EXPERIMENTAL

Subcutaneous (SQ) injection using an autoinjector

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

Treatment B

ACTIVE COMPARATOR

Intramuscular injection (IM) using syringe and needle

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:

• \. 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

You may not qualify if:

• 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.
• History or current evidence of deep vein thrombosis, pulmonary embolism or arterial thromboembolic disease (e.g., stroke, myocardial infarction).
• Known, suspected, or current history of carcinoma of the breast.
• Subjects with a past history of breast cancer on aromatase inhibitors or selective estrogen receptor modulators.
• Known, suspected, or current history of hormone dependent tumor within the last 5 years.
• Any current or recent (within previous 12 months) genital bleeding of unknown etiology.
• Receipt of any investigational drug within 30 days.
• 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.
• Any estrogen, progestin, or selective estrogen receptor modulator (SERM) treatment within specified time windows before the study start, ranging from 2 to 6 months.
• High blood pressure at the screening evaluation, defined as systolic blood pressure \> 150 mm Hg or diastolic blood pressure \> 90 mm Hg.
• History of excessive alcohol consumption (on average more than 14 units of alcohol/week) during the past 12 months.
• Use of tobacco products within 30 days of the start of the study.

Sponsors & Collaborators

• AMAG Pharmaceuticals, Inc.: lead

Study Sites (5)

Unknown Facility

Anaheim, California, 92801, United States

Location

Unknown Facility

DeLand, Florida, 32720, United States

Location

Unknown Facility

Miami, Florida, 33143, United States

Location

Unknown Facility

Orlando, Florida, 32809, United States

Location

Unknown Facility

San Antonio, Texas, 78209, United States

Location

Related Publications (1)

• 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.

  PMID: 29191450 DERIVED

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

Results Point of Contact

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

CTInterest@covispharma.com

Study Officials

• Julie Krop, MD

  AMAG Pharmaceuticals, Inc.

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• 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 21, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: April 28, 2022
• Results First Posted: November 30, 2018

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)