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
Condition: Comparing Bioavailability When Makena® is Administered in Healthy Post-menopausal Women
Intervention: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL); Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)
Intervention MeSH terms: 17 alpha-Hydroxyprogesterone Caproate; 11-hydroxyprogesterone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 122.0
Sex: Female
Minimum age: 50 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

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

Eligibility criteria:

        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.