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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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The investigators are doing this study to look at how different doses of the Depot medroxyprogesterone acetate (DMPA) shot effect weight gain and bone mineral density in teens. The investigators hope that what the investigators learn from this study will be used to develop ways to keep girls from gaining weight or losing bone density when receiving DMPA.
Depot medroxyprogesterone acetate (DMPA) is a generic form of the DepoProvera® shot. When receiving the birth control shot some girls gain a lot of weight while others do not. Some girls also lose bone mineral density (BMD). Bone mineral density is the amount of weight and thickness of the bones.
In this study 1 of 3 doses of DMPA will be given as an injection into the muscle in the arm. The 150mg dose is approved for use in this age group by the Food and Drug Administration (FDA) when given into the muscle. The 104mg dose is approved for use in this age group by the FDA only when given under the skin therefore it is considered experimental. The 75mg dose is also considered experimental as this dose is not FDA approved regardless of how it is given.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 150 mg DMPA | Active Comparator | Depot medroxyprogesterone acetate (DMPA) 150 mg every 12 weeks IM |
|
| 104mg DMPA | Experimental | Depot medroxyprogesterone acetate (DMPA) 104 mg every 12 weeks IM |
|
| 75mg DMPA | Experimental | Depot medroxyprogesterone acetate (DMPA) 75 mg every 12 weeks IM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Depot medroxyprogesterone acetate (DMPA) | Drug | 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to 48 Weeks | Lumbar spine bone mineral density measured at baseline and 48 weeks. Percent change over this time was calculated. | Percent change from baseline to 48 Weeks |
| Proportion of Participants With >5% Weight Gain at 24 Weeks | Individual subjects will be assessed after their Week 24 visit. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Total Hip BMD From Baseline to 48 Weeks | Total hip bone mineral density was assessed at baseline and 48 weeks. Percent change from baseline to 48 weeks was calculated. | Percent change from baseline to 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Bonny, MD | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 150 mg DMPA | Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months |
| FG001 | 104mg DMPA | Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months |
| FG002 | 75mg DMPA | Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 150 mg DMPA | Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months |
| BG001 | 104mg DMPA | Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to 48 Weeks | Lumbar spine bone mineral density measured at baseline and 48 weeks. Percent change over this time was calculated. | Posted | Mean | Standard Deviation | percent change | Percent change from baseline to 48 Weeks |
|
Up to 48 weeks
Solicited at each visit
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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 | 150 mg DMPA | Depot medroxyprogesterone acetate (DMPA):150mg DMPA, IM, every 12 weeks for 12 months |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrea Bonny | The Research Institute at Nationwide Children's Hospital | 614-722-2450 | andrea.bonny@nationwidechildrens.org |
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| ID | Term |
|---|---|
| D015430 | Weight Gain |
| D014592 | Uterine Hemorrhage |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| BG002 | 75mg DMPA | Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 75mg DMPA |
Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months |
|
|
| Primary | Proportion of Participants With >5% Weight Gain at 24 Weeks | Individual subjects will be assessed after their Week 24 visit. | Posted | Count of Participants | Participants | Week 24 |
|
|
|
| Secondary | Percent Change in Total Hip BMD From Baseline to 48 Weeks | Total hip bone mineral density was assessed at baseline and 48 weeks. Percent change from baseline to 48 weeks was calculated. | Posted | Mean | Standard Deviation | Percent change | Percent change from baseline to 48 weeks |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 8 |
| 12 |
| EG001 | 104 mg DMPA | Depot medroxyprogesterone acetate (DMPA):104mg DMPA, IM, every 12 weeks for 12 months | 0 | 11 | 0 | 11 | 11 | 11 |
| EG002 | 75 mg DMPA | Depot medroxyprogesterone acetate (DMPA):75mg DMPA, IM, every 12 weeks for 12 months | 0 | 11 | 0 | 11 | 10 | 11 |
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lip infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment | Cold sore |
|
| Stomach pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Viral infection not specified | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment | Contact dermatitis |
|
| Uterine pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment | Cramping |
|
| Urinary tract infection | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Irregular menstruation | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Vaginal pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Burn | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Vaginal infection | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
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| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |