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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Subcutaneous (SQ) injection using an autoinjector |
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| Treatment B | Active Comparator | Intramuscular injection (IM) using syringe and needle |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) | Drug |
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| |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Areas Under the Curve (AUC) to the Last Time With a Concentration ≥ LLOQ [AUC0-t] and to Infinity [AUCinf] | 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 | 9 weeks |
| Comparison of the Maximum Plasma Concentration (Cmax) | Comparison of the maximum plasma concentration (Cmax) for the Primary PK Population | 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Tmax | Comparison of PK parameter Tmax for the Primary PK population | 9 weeks |
| Comparison of AUC (0-168) | Comparison of PK Parameter AUC (0-168) for the Primary PK Population |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Julie Krop, MD | AMAG Pharmaceuticals, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim | California | 92801 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29191450 | Derived | Krop J, Kramer WG. Comparative Bioavailability of Hydroxyprogesterone Caproate Administered via Intramuscular Injection or Subcutaneous Autoinjector in Healthy Postmenopausal Women: A Randomized, Parallel Group, Open-label Study. Clin Ther. 2017 Dec;39(12):2345-2354. doi: 10.1016/j.clinthera.2017.10.020. Epub 2017 Nov 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment A | Subcutaneous (SQ) injection using an autoinjector Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) |
| FG001 | Treatment B | Intramuscular injection (IM) using syringe and needle Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) |
| Drug |
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| 9 weeks |
| Comparison of t1/2 | Comparison of PK parameter t1/2 for the Primary PK Population | 9 weeks |
| Comparison of Elimination Rate Constant | Comparison of the elimination rate constant for the Primary PK Population | 9 weeks |
| DeLand |
| Florida |
| 32720 |
| United States |
| Miami | Florida | 33143 | United States |
| Orlando | Florida | 32809 | United States |
| San Antonio | Texas | 78209 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment A | Subcutaneous (SQ) injection using an autoinjector Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) |
| BG001 | Treatment B | Intramuscular injection (IM) using syringe and needle Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 Areas Under the Curve (AUC) to the Last Time With a Concentration ≥ LLOQ [AUC0-t] and to Infinity [AUCinf] | 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 | The Primary PK Population consisted of 45 subjects each for both treatments for whom whole blood was analyzed. Subjects were excluded from Treatment A and Treatment B due to insufficient number of samples for planned analyses. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr x ng/mL | 9 weeks |
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| Primary | Comparison of the Maximum Plasma Concentration (Cmax) | Comparison of the maximum plasma concentration (Cmax) for the Primary PK Population | The Primary PK Population consisted of 45 subjects each for both treatments for whom whole blood was analyzed. Subjects were excluded from Treatment A and Treatment B due to insufficient number of samples for planned analyses. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 9 weeks |
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| Secondary | Comparison of Tmax | Comparison of PK parameter Tmax for the Primary PK population | The Primary PK Population consisted of 45 subjects each for both treatments for whom whole blood was analyzed. Subjects were excluded from Treatment A and Treatment B due to insufficient number of samples for planned analyses. | Posted | Geometric Mean | Full Range | hr | 9 weeks |
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| Secondary | Comparison of AUC (0-168) | Comparison of PK Parameter AUC (0-168) for the Primary PK Population | The Primary PK Population consisted of 45 subjects each for both treatments for whom whole blood was analyzed. Subjects were excluded from Treatment A and Treatment B due to insufficient number of samples for planned analyses. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr x ng/mL | 9 weeks |
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| Secondary | Comparison of t1/2 | Comparison of PK parameter t1/2 for the Primary PK Population | The Primary PK Population consisted of 45 subjects each for both treatments for whom whole blood was analyzed. Subjects were excluded from Treatment A and Treatment B due to insufficient number of samples for planned analyses. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr | 9 weeks |
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| Secondary | Comparison of Elimination Rate Constant | Comparison of the elimination rate constant for the Primary PK Population | The Primary PK Population consisted of 45 subjects each for both treatments for whom whole blood was analyzed. Subjects were excluded from Treatment A and Treatment B due to insufficient number of samples for planned analyses. | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/hr | 9 weeks |
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9 weeks.
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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 Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) | 0 | 59 | 32 | 59 | ||
| EG001 | Treatment B | Intramuscular injection (IM) using syringe and needle Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) | 0 | 61 | 23 | 61 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Injection site bruising | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Injection site discoloration | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Injection site inflammation | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Injection site paraesthesia | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Injection site pruritis | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Vessel puncture site reaction | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Tooth abscess | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Thermal burn | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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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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| AUC(inf) |
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