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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513561-39-00 | Registry Identifier | CTIS (EU) |
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The purpose of the study is to compare the pharmacokinetics and relative bioavailability of medroxyprogesterone in healthy female participants following subcutaneous injection of Sayana Press into the upper arm versus anterior thigh and abdomen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sayana Press, Upper Arm injection | Experimental | Sayana Press, administered subcutaneously into upper arm |
|
| Sayana Press, anterior thigh | Active Comparator | Sayana Press, administered subcutaneously into anterior thigh |
|
| Sayana Press, abdomen | Active Comparator | Sayana Press, administered subcutaneously into abdomen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sayana Press | Combination Product | Sayana Press is a drug-device combination and is considered a medical product in the EU. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Trough Concentration (Ctrough) of Medroxyprogesterone | Day 92 post dose | |
| Area under the curve from time zero to end of dosing interval (AUCtau) | pre-dose, up to 92 days post dose | |
| Maximum Observed Serum Concentration (Cmax) of Medroxyprogesterone | pre-dose, up to 92 days post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Progesterone Level | pre-dose, up to 99 days post dose | |
| Serum Estradiol Level | pre-dose, up tp 99 days post dose | |
| Serum Luteinizing Hormone (LH) Level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit - Brussels | Brussels | Bruxelles-capitale, Région de | B-1070 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| D008525 | Medroxyprogesterone |
| ID | Term |
|---|---|
| D006908 | Hydroxyprogesterones |
| D011374 | Progesterone |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
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|
| pre-dose, up to 99 days post dose |
| Serum Follicle-Stimulating Hormone (FSH) Level | pre-dose, up to 99 days post dose |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Informed consent document to 150 days post dose or until study completion, whichever is longer. |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | baseline, up to 150 days post dose or until study completion, whichever is longer |
| Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities | Screening, Day 1, up to 150 days post dose or until study completion, whichever is longer |
| D011278 |
| Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |