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

NCT04893798 | Completed Phase 1

• 2 other identifiers: A67910422024-513561-39-00
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• 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.

Study Arms (3)

Sayana Press, Upper Arm injection

EXPERIMENTAL

Sayana Press, administered subcutaneously into upper arm

Combination Product: Sayana Press

Sayana Press, anterior thigh

ACTIVE COMPARATOR

Sayana Press, administered subcutaneously into anterior thigh

Combination Product: Sayana Press

Sayana Press, abdomen

ACTIVE COMPARATOR

Sayana Press, administered subcutaneously into abdomen

Combination Product: Sayana Press

Interventions

Sayana Press COMBINATION_PRODUCT

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

Also known as: Medroxyprogesterone

Sayana Press, Upper Arm injection; Sayana Press, abdomen; Sayana Press, anterior thigh

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

Location

Related Links

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

MeSH Terms

Interventions

Medroxyprogesterone

Intervention Hierarchy (Ancestors)

Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 20, 2021
• Study Start: September 16, 2021
• Primary Completion: July 24, 2025
• Study Completion: July 24, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)