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

NCT ID: NCT04893798

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-16
• Study Completion Date: 2025-07-24

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Sayana Press, Upper Arm injection

Sayana Press, administered subcutaneously into upper arm

Group Type: EXPERIMENTAL

Sayana Press

Intervention Type: COMBINATION_PRODUCT

Sayana Press is a drug-device combination and is considered a medical product in the EU.

Sayana Press, anterior thigh

Sayana Press, administered subcutaneously into anterior thigh

Group Type: ACTIVE_COMPARATOR

Sayana Press

Intervention Type: COMBINATION_PRODUCT

Sayana Press is a drug-device combination and is considered a medical product in the EU.

Sayana Press, abdomen

Sayana Press, administered subcutaneously into abdomen

Group Type: ACTIVE_COMPARATOR

Sayana Press

Intervention Type: COMBINATION_PRODUCT

Sayana Press is a drug-device combination and is considered a medical product in the EU.

Interventions

Sayana Press

Sayana Press is a drug-device combination and is considered a medical product in the EU.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Medroxyprogesterone

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région de, Belgium

Countries

Belgium

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=A6791042

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

Other Identifiers

2024-513561-39-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

A6791042

Identifier Type: -

Identifier Source: org_study_id