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| Name | Class |
|---|---|
| Eastern Virginia Medical School | OTHER |
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A single-arm trial to demonstrate that Depo-SubQ Provera injected in the upper arm is adequate for effective contraception
A single-arm trial to demonstrate that the blood levels of medroxyprogesterone acetate are adequate for effective contraception when Depo-SubQ Provera 104 is injected in the upper arm
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medroxyprogesterone acetate | Experimental | Single injection of Medroxyprogesterone acetate (hormonal contraceptive) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medroxyprogesterone acetate | Drug | Injectable hormonal contraceptive |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (Maximal Serum Concentration of Medroxyprogesterone Acetate (MPA)) | 120 days following injection | |
| Tmax (Time to Cmax) | 120 days following injection | |
| AUC 0-91 (Area Under Curve) | first 91 days following injection | |
| MPA Concentration at Day 91 (C91) | day 91 after first injection | |
| MPA Concentration at Day 104 (C104) | day 104 after injection | |
| MPA Concentration at Day 120 (C120) | day 120 after injection |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| David Archer, MD | Eastern Virginia Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center, Dept. of Obstetrics & Gynegology, Eastern Virginia Medical School | Norfolk | Virginia | 23507 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Medroxyprogesterone Acetate | Single injection of Medroxyprogesterone acetate (hormonal contraceptive) Medroxyprogesterone acetate : Injectable hormonal contraceptive |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Medroxyprogesterone Acetate | Single injection of Medroxyprogesterone acetate (hormonal contraceptive) Medroxyprogesterone acetate : Injectable hormonal contraceptive |
| 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 |
| 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 | Cmax (Maximal Serum Concentration of Medroxyprogesterone Acetate (MPA)) | Posted | Mean | Standard Deviation | ng/mL | 120 days following injection |
|
|
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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 | Medroxyprogesterone Acetate | Single injection of Medroxyprogesterone acetate (hormonal contraceptive) Medroxyprogesterone acetate : Injectable hormonal contraceptive |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bipolar Disorder | Psychiatric disorders | MedDRA 16 | Systematic Assessment | exacerbation of pre-existing Bipolar Disorder |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vera Halpern, MD | FHI 360 | 919-54-7040 | 11390 | vhalpern@fhi360.org |
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| ID | Term |
|---|---|
| D017258 | Medroxyprogesterone Acetate |
| ID | Term |
|---|---|
| D008525 | Medroxyprogesterone |
| D006908 | Hydroxyprogesterones |
| D011374 | Progesterone |
| D011282 | Pregnenediones |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Tmax (Time to Cmax) | Posted | Median | Inter-Quartile Range | days | 120 days following injection |
|
|
|
| Primary | AUC 0-91 (Area Under Curve) | Posted | Mean | Standard Deviation | ng day/mL | first 91 days following injection |
|
|
|
| Primary | MPA Concentration at Day 91 (C91) | Posted | Mean | Standard Deviation | ng/mL | day 91 after first injection |
|
|
|
| Primary | MPA Concentration at Day 104 (C104) | Posted | Mean | Standard Deviation | ng/mL | day 104 after injection |
|
|
|
| Primary | MPA Concentration at Day 120 (C120) | Posted | Mean | Standard Deviation | ng/mL | day 120 after injection |
|
|
|
| 2 |
| 26 |
| 17 |
| 26 |
|
| Hysterectomy | Surgical and medical procedures | MedDRA 16 | Systematic Assessment | total abdominal hysterectomy |
|
| vaginal infection (bacterial vaginosis) | Reproductive system and breast disorders | Systematic Assessment |
|
| bladder pain | Renal and urinary disorders | Systematic Assessment |
|
| Biopsy breast | Investigations | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dental infection | Infections and infestations | Systematic Assessment |
|
| Dental pain | Gastrointestinal disorders | Systematic Assessment |
|
| Bipolar disorder | Psychiatric disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Dispepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Injection site pain | General disorders | Systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | Systematic Assessment |
|
| Corneal abrasion | Eye disorders | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pyelonephritis | Renal and urinary disorders | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Sinusitis (sinus congestion) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sinusitis (sinus headache) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | Systematic Assessment |
|
| Hysterectomy | Surgical and medical procedures | Systematic Assessment |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Viral infection | Infections and infestations | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | Systematic Assessment |
|
| Vulvovaginal candidiasis (yeast infection) | Reproductive system and breast disorders | Systematic Assessment |
|
| Vulvovaginal candidiasis (vaginal yeast infection) | Reproductive system and breast disorders | Systematic Assessment |
|
| sinusitis (congestion) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D011283 |
| Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |