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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-03-31

Brief Summary

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

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment A

Subcutaneous (SQ) injection using an autoinjector

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Treatment B

Intramuscular injection (IM) using syringe and needle

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Interventions

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

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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Makena SQ Makena

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes