Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) in Healthy Post-menopausal Women
Conditions
Brief summary
To demonstrate that Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) delivered subcutaneously via auto-injector is associated with less pain as compared to intramuscular injections of Makena®
Interventions
Sponsors
AMAG Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Female subjects aged 50 to 75 years of age, inclusive, at Screening Visit. 2. Follicle stimulating hormone (FSH) levels greater than 40 mIU/mL. 3. Naturally or surgically postmenopausal with or without an intact uterus.
Exclusion criteria
1. Have history of or positive test results for HIV or hepatitis B or C. 2. A significant history or current evidence of chronic infectious disease, organ dysfunction especially cardiovascular, renal, or hepatic disorders or other medical condition. 3. Receiving or have received chronic opioid therapy within 12 months. 4. Unwilling to stop taking/using: * pain medication. * topical analgesic or anti-inflammatory treatment. Topical analgesics must be washed out by at least 72 hours in the areas to be treated before randomization. 5. History of alcohol abuse (regularly drinks \> 4 units of alcohol per day; 8 oz. beer, 3 oz. wine, 1 oz. spirits) or prescription/illicit drug abuse in the last 12 months. 6. Currently taking any estrogen/progesterone hormone replacement therapy (HRT). 7. 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. 8. Poorly controlled diabetes (Hgb A1C \>8). 9. Current or history of thrombosis or thromboembolic disorders. 10. Known or suspected breast cancer, other hormone-sensitive cancer or tumor, or history of these conditions within the last 5 years. 11. Any current or recent (within previous 12 months) vaginal bleeding. 12. Uncontrolled hypertension. 13. A chronic pain condition (i.e. chronic back pain) that may confound the assessments of injection pain.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Average Pain Intensity | 4 weeks | Comparison of average pain intensity associated with the administration of Makena® via subcutaneous autoinjector versus intramuscular injection (averaged over 4 visits). Score on a scale: 0 (No Pain) up to 10 (Worst Pain Imaginable) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Assessment of Ease of Injection Technique | 4 weeks | Investigate the clinician's assessment of the ease of injection technique associated with the administration of Makena® via subcutaneous auto-injector versus intramuscular injection as measured by a categorical scale. Scores were as follows: completely dissatisfied = -3; mostly dissatisfied = -2, somewhat dissatisfied = -1, neither satisfied nor unsatisfied = 0, somewhat satisfied = 1, mostly satisfied = 2, completely satisfied = 3 |
| Clinician Assessment of Ease of Drug Preparation | 4 weeks | Investigate the clinician's assessment of the ease of drug preparation associated with the administration of Makena® via subcutaneous auto-injector versus intramuscular injection as measured by a categorical scale. Scores were as follows: completely dissatisfied = -3; mostly dissatisfied = -2, somewhat dissatisfied = -1, neither satisfied nor unsatisfied = 0, somewhat satisfied = 1, mostly satisfied = 2, completely satisfied = 3 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment A Subcutaneous (SQ) injection using an autoinjector weekly over 4 weeks (4 injections)
Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) | 30 |
| Treatment B Intramuscular injection (IM) using syringe and needle weekly over 4 weeks (4 injections)
Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Treatment B | Treatment A | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 7 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 23 Participants | 50 Participants |
| Age, Continuous | 56.5 years STANDARD_DEVIATION 4.23 | 59.3 years STANDARD_DEVIATION 6.39 | 57.9 years STANDARD_DEVIATION 5.55 |
| Region of Enrollment United States | 30 Participants | 30 Participants | 60 Participants |
| Sex: Female, Male Female | 30 Participants | 30 Participants | 60 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 17 / 30 | 13 / 30 |
| serious Total, serious adverse events | 1 / 30 | 0 / 30 |
Outcome results
Primary
Comparison of Average Pain Intensity
Comparison of average pain intensity associated with the administration of Makena® via subcutaneous autoinjector versus intramuscular injection (averaged over 4 visits). Score on a scale: 0 (No Pain) up to 10 (Worst Pain Imaginable)
Time frame: 4 weeks
Population: The Comparison of Average Pain Intensity outcome was not analyzed. Pain assessments for participants included Adverse Events of Injection Site Pain reporting. 3 participants in Treatment Group A and 2 participants in Treatment Group B reported Injection Site Pain.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment A | Comparison of Average Pain Intensity | 3 Participants with Injection Site Pain |
| Treatment B | Comparison of Average Pain Intensity | 2 Participants with Injection Site Pain |
Secondary
Clinician Assessment of Ease of Drug Preparation
Investigate the clinician's assessment of the ease of drug preparation associated with the administration of Makena® via subcutaneous auto-injector versus intramuscular injection as measured by a categorical scale. Scores were as follows: completely dissatisfied = -3; mostly dissatisfied = -2, somewhat dissatisfied = -1, neither satisfied nor unsatisfied = 0, somewhat satisfied = 1, mostly satisfied = 2, completely satisfied = 3
Time frame: 4 weeks
Population: Analysis population is comprised of all subjects who were randomized and received study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A | Clinician Assessment of Ease of Drug Preparation | 2.8 units on a scale | Standard Deviation 0.43 |
| Treatment B | Clinician Assessment of Ease of Drug Preparation | 2.5 units on a scale | Standard Deviation 1.14 |
p-value: 0.23495% CI: [-0.2, 0.7]t-test, 2 sided
Secondary
Clinician Assessment of Ease of Injection Technique
Investigate the clinician's assessment of the ease of injection technique associated with the administration of Makena® via subcutaneous auto-injector versus intramuscular injection as measured by a categorical scale. Scores were as follows: completely dissatisfied = -3; mostly dissatisfied = -2, somewhat dissatisfied = -1, neither satisfied nor unsatisfied = 0, somewhat satisfied = 1, mostly satisfied = 2, completely satisfied = 3
Time frame: 4 weeks
Population: Analysis population is comprised of all subjects who were randomized and received study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A | Clinician Assessment of Ease of Injection Technique | 2.8 units on a scale | Standard Deviation 0.43 |
| Treatment B | Clinician Assessment of Ease of Injection Technique | 2.3 units on a scale | Standard Deviation 1.32 |
p-value: 0.09395% CI: [-0.1, 0.9]t-test, 2 sided