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
Phase 1
Completed
- Conditions
- Comparing Bioavailability When Makena® is Administered in Healthy Post-menopausal Women
- Interventions
- Registration Number
- NCT02940522
- Lead Sponsor
- AMAG Pharmaceuticals, Inc.
- 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®.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 122
Inclusion Criteria
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment A Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) Subcutaneous (SQ) injection using an autoinjector Treatment B Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) Intramuscular injection (IM) using syringe and needle
- Primary Outcome Measures
Name Time Method Comparison of the Maximum Plasma Concentration (Cmax) 9 weeks Comparison of the maximum plasma concentration (Cmax) for the Primary PK Population
Comparison of Areas Under the Curve (AUC) to the Last Time With a Concentration ≥ LLOQ [AUC0-t] and to Infinity [AUCinf] 9 weeks 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
- Secondary Outcome Measures
Name Time Method Comparison of Elimination Rate Constant 9 weeks Comparison of the elimination rate constant for the Primary PK Population
Comparison of Tmax 9 weeks Comparison of PK parameter Tmax for the Primary PK population
Comparison of AUC (0-168) 9 weeks Comparison of PK Parameter AUC (0-168) for the Primary PK Population
Comparison of t1/2 9 weeks Comparison of PK parameter t1/2 for the Primary PK Population