A Study Comparing Subcutaneous Injection of Sayana Press In the Upper Arm Versus Anterior Thigh and Abdomen

Study Overview
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Brief Summary
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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.

Official Title
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A PHASE 1, RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL-GROUP STUDY TO COMPARE THE PHARMACOKINETICS AND RELATIVE BIOAVAILABILITY OF MEDROXYPROGESTERONE ACETATE IN HEALTHY FEMALE PARTICIPANTS FOLLOWING SUBCUTANEOUS INJECTION OF SAYANA PRESS IN THE UPPER ARM RELATIVE TO ANTERIOR THIGH AND ABDOMEN

Conditions
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Healthy

Intervention / Treatment
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* Combination Product: Sayana Press


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pre-menopausal female participants, 18 to 45 years of age, inclusive, at the time of signing the ICD who are at low risk of pregnancy Participants who have a regular menstrual cycle (between 21 and 42 days in length). No previous injection of depot MPA for 1 year prior to enrollment. BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb). Exclusion Criteria: History of abnormal cervical cytology within the last 3 years that has not been adequately treated (at least 2 subsequent normal smears). However, ASCUS is permitted in this study. Known or suspected malignancy of the breast or genital organs. Known with metabolic bone disease. Undiagnosed abnormal genital bleeding. Known or suspected pregnancy; or nursing females. History of febrile illness within 5 days prior to the first dose. Participant with active thrombophlebitis or whose medical history suggests that they may be at increased risk for osteoporosis, thromboembolic disease or cerebral vascular disease. Use of prescription or nonprescription drugs, vitamins, herbal preparations and dietary supplements capable of inducing hepatic metabolism (eg, barbiturates, rifampicin, carbamazepine or St John's Wort) or any medication known to be a cytochrome P450 inhibitor within 30 days (or 5 half-lives of the substance, whichever is longer) of enrollment in the study Use of hormonal contraception (including hormone releasing intrauterine device) within the last 3 months (and should have resumed regular menstruation). Baseline 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline QTc interval >450 msec, complete LBBB, signs of an acute or indeterminate-age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second- or third-degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is >450 msec, this interval should be rate-corrected using the Fridericia method and the resulting QTcF should be used for decision making and reporting. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the participant's eligibility. Computer-interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sayana Press, Upper Arm injection<br>Sayana Press, administered subcutaneously into upper arm | Combination Product: Sayana Press<br>* Sayana Press is a drug-device combination and is considered a medical product in the EU.<br>* Other names: Medroxyprogesterone;|
| Active Comparator: Sayana Press, anterior thigh<br>Sayana Press, administered subcutaneously into anterior thigh | Combination Product: Sayana Press<br>* Sayana Press is a drug-device combination and is considered a medical product in the EU.<br>* Other names: Medroxyprogesterone;|
| Active Comparator: Sayana Press, abdomen<br>Sayana Press, administered subcutaneously into abdomen | Combination Product: Sayana Press<br>* Sayana Press is a drug-device combination and is considered a medical product in the EU.<br>* Other names: Medroxyprogesterone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |