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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Combination product: Sayana Press

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles-capitale, Région DE
    • Brussels, Bruxelles-capitale, Région DE, Belgium, B-1070
      • Pfizer Clinical Research Unit - Brussels

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2021
• Primary Completion (Actual): July 24, 2025
• Study Completion (Actual): July 24, 2025

Study Registration Dates

• First Submitted: May 14, 2021
• First Submitted That Met QC Criteria: May 14, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Contraceptive Agents, Hormonal; Antineoplastic Agents; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Hormonal; Contraceptives, Oral, Synthetic; Contraceptive Agents, Male; Medroxyprogesterone Acetate; Medroxyprogesterone
• Other Study ID Numbers: A6791042; 2024-513561-39-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No