Phase 1
Completed N=120
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
Comparing Bioavailability When Makena® is Administered in Healthy Post-menopausal Women
Source: ClinicalTrials.gov NCT02940522 ↗
Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: Comparison of Areas Under the Curve (AUC) to the Last Time With a Concentration ≥ LLOQ [AUC0-t] and to Infinity [AUCinf] — 2,313; 2,098; 2,469; 2,175 hr x ng/mL
Summary
To demonstrate that a single dose of Makena® delivered SQ via auto-injector has comparable bioavailability to a single IM injection of Makena®.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Areas Under the Curve (AUC) to the Last Time With a Concentration ≥ LLOQ [AUC0-t] and to Infinity [AUCinf] |
2,313; 2,098; 2,469; 2,175 | — |
| PRIMARY Comparison of the Maximum Plasma Concentration (Cmax) |
7.88; 6.91 | — |
| SECONDARY Comparison of Tmax |
48.1; 49.7 | — |
| SECONDARY Comparison of AUC (0-168) |
813; 790 | — |
| SECONDARY Comparison of t1/2 |
212; 185 | — |
| SECONDARY Comparison of Elimination Rate Constant |
0.0033; 0.0038 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02940522). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.