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

AMAG Pharmaceuticals

Status and phase: Completed; Phase 1

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

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02940522

AMAG-HPC-PK-010

Details and patient eligibility

About

To demonstrate that a single dose of Makena® delivered SQ via auto-injector has comparable bioavailability to a single IM injection of Makena®.

Enrollment: 122 patients

Sex: Female

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

Treatment A

Experimental group

Description:

Subcutaneous (SQ) injection using an autoinjector

Treatment:

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

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

Treatment B

Active Comparator group

Description:

Intramuscular injection (IM) using syringe and needle

Treatment:

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

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