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The Sponsor elected to discontinue the study prematurely due to business reasons
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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®
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Subcutaneous (SQ) injection using an autoinjector weekly over 4 weeks (4 injections) |
|
| Treatment B | Active Comparator | Intramuscular injection (IM) using syringe and needle weekly over 4 weeks (4 injections) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Have history of or positive test results for HIV or hepatitis B or C.
A significant history or current evidence of chronic infectious disease, organ dysfunction especially cardiovascular, renal, or hepatic disorders or other medical condition.
Receiving or have received chronic opioid therapy within 12 months.
Unwilling to stop taking/using:
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.
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 (Hgb A1C >8).
Current or history of thrombosis or thromboembolic disorders.
Known or suspected breast cancer, other hormone-sensitive cancer or tumor, or history of these conditions within the last 5 years.
Any current or recent (within previous 12 months) vaginal bleeding.
Uncontrolled hypertension.
A chronic pain condition (i.e. chronic back pain) that may confound the assessments of injection pain.
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| Name | Affiliation | Role |
|---|---|---|
| Neil Singla, MD | Lotus Clinical Research, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lotus Clinical Research, LLC | Pasadena | California | 91105 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment A | Subcutaneous (SQ) injection using an autoinjector weekly over 4 weeks (4 injections) Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) |
| FG001 | Treatment B |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) |
| Drug |
|
|
| 4 weeks |
| 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 | 4 weeks |
Intramuscular injection (IM) using syringe and needle weekly over 4 weeks (4 injections)
Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment A | Subcutaneous (SQ) injection using an autoinjector weekly over 4 weeks (4 injections) Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) |
| BG001 | Treatment B | Intramuscular injection (IM) using syringe and needle weekly over 4 weeks (4 injections) Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | 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. | Posted | Number | Participants with Injection Site Pain | 4 weeks |
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| 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 | Analysis population is comprised of all subjects who were randomized and received study drug. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
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| |||||||||||||||||||||||||||||
| 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 | Analysis population is comprised of all subjects who were randomized and received study drug. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
|
|
Approximately 66 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment A | Subcutaneous (SQ) injection using an autoinjector weekly over 4 weeks (4 injections) Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) | 1 | 30 | 17 | 30 | ||
| EG001 | Treatment B | Intramuscular injection (IM) using syringe and needle weekly over 4 weeks (4 injections) Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) | 0 | 30 | 13 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA Version 19.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA Version 19.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA Version 19.0 | Systematic Assessment |
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| Injection site nodule | General disorders | MedDRA Version 19.0 | Systematic Assessment |
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| Injection site paraesthesia | General disorders | MedDRA Version 19.0 | Systematic Assessment |
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| Injection site pruritis | General disorders | MedDRA Version 19.0 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA Version 19.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 19.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 19.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA Version 19.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA Version 19.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 19.0 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA Version 19.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA Version 19.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA Version 19.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA Version 19.0 | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA Version 19.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 19.0 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 19.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Version 19.0 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA Version 19.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA Version 19.0 | Systematic Assessment |
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| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA Version 19.0 | Systematic Assessment |
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| Cardiac murmur | Investigations | MedDRA Version 19.0 | Systematic Assessment |
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| Liver function test increased | Investigations | MedDRA Version 19.0 | Systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA Version 19.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA Version 19.0 | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA Version 19.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 19.0 | Systematic Assessment |
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| Polydipsia | Metabolism and nutrition disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA Version 19.0 | Systematic Assessment |
|
The Sponsor elected to discontinue the study prematurely due to business reasons. The only parameters analyzed for efficacy were Ease of Drug Preparation and Ease of Injection Technique.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | AMAG Pharmaceuticals, Inc. | CTInterest@covispharma.com |
| ID | Term |
|---|---|
| D000077713 | 17 alpha-Hydroxyprogesterone Caproate |
| ID | Term |
|---|---|
| D019326 | 17-alpha-Hydroxyprogesterone |
| D006908 | Hydroxyprogesterones |
| D011374 | Progesterone |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| >=65 years |
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| Male |
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