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

• ClinicalTrials.gov Identifier: NCT04893798
• Recruitment Status: Recruiting
• First Posted: May 20, 2021
• Last Update Posted: March 17, 2023
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Combination Product: Sayana Press	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: 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
• Actual Study Start Date: September 16, 2021
• Estimated Primary Completion Date: August 24, 2023
• Estimated Study Completion Date: August 24, 2023

Arms and Interventions

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 Name: 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 Name: 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 Name: Medroxyprogesterone

Outcome Measures

Primary Outcome Measures :

1. Serum Trough Concentration (Ctrough) of Medroxyprogesterone [ Time Frame: Day 92 post dose ]
2. Area under the curve from time zero to end of dosing interval (AUCtau) [ Time Frame: pre-dose, up to 92 days post dose ]
3. Maximum Observed Serum Concentration (Cmax) of Medroxyprogesterone [ Time Frame: pre-dose, up to 92 days post dose ]

Secondary Outcome Measures :

1. Serum Progesterone Level [ Time Frame: pre-dose, up to 99 days post dose ]
2. Serum Estradiol Level [ Time Frame: pre-dose, up tp 99 days post dose ]
3. Serum Luteinizing Hormone (LH) Level [ Time Frame: pre-dose, up to 99 days post dose ]
4. Serum Follicle-Stimulating Hormone (FSH) Level [ Time Frame: pre-dose, up to 99 days post dose ]
5. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Informed consent document to 150 days post dose or until study completion, whichever is longer. ]
6. Number of Participants With Clinically Significant Change From Baseline in Vital Signs [ Time Frame: baseline, up to 150 days post dose or until study completion, whichever is longer ]
7. Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities [ Time Frame: Screening, Day 1, up to 150 days post dose or until study completion, whichever is longer ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Contacts

Contact: Pfizer CT.gov Call Center; 1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Belgium

Brussels Clinical Research Unit; Recruiting

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

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT04893798
• Other Study ID Numbers: A6791042; 2021-001035-54 ( EudraCT Number )
• First Posted: May 20, 2021
• Last Update Posted: March 17, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Medroxyprogesterone Acetate; Medroxyprogesterone; Contraceptives, Oral, Hormonal; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptives, Oral, Synthetic; Contraceptive Agents, Male; Antineoplastic Agents, Hormonal; Antineoplastic Agents