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

Phase 1

Recruiting

• Conditions: Healthy
• Interventions: Combination Product: Sayana Press

• Registration Number: NCT04893798
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2021-05-14
• Study First Submitted QC: 2021-05-14
• Study First Posted: 2021-05-20
• Study Start: 2021-09-16
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-07
• Primary Completion: 2025-12-10
• Study Completion: 2025-12-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 68

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).

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sayana Press, Upper Arm injection	Sayana Press	Sayana Press, administered subcutaneously into upper arm
Sayana Press, anterior thigh	Sayana Press	Sayana Press, administered subcutaneously into anterior thigh
Sayana Press, abdomen	Sayana Press	Sayana Press, administered subcutaneously into abdomen

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Serum Progesterone Level	pre-dose, up to 99 days post dose
Serum Luteinizing Hormone (LH) 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.
Serum Estradiol Level	pre-dose, up tp 99 days post dose
Serum Follicle-Stimulating Hormone (FSH) Level	pre-dose, up to 99 days post dose
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

Trial Locations

Locations (1)

Pfizer Clinical Research Unit - Brussels; 🇧🇪 Brussels, Bruxelles-capitale, Région DE, Belgium