HealthyPhase 1NCT04893798
A Study Comparing Subcutaneous Injection of Sayana Press In the Upper Arm Versus Anterior Thigh and Abdomen
A Phase 1 study testing Sayana Press in people with Healthy, run by Pfizer at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sayana Press
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Sep 2021to 24 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, B-1070
About this study
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
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
- Being tested
- Sayana Press
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sayana PressCombination product
Also called Medroxyprogesterone
Sayana Press is a drug-device combination and is considered a medical product in the EU.
| Study group | Role | What they receive |
|---|---|---|
| Sayana Press, Upper Arm injection | Experimental | Sayana Press, administered subcutaneously into upper arm Receives: Combination Product: Sayana Press |
| Sayana Press, anterior thigh | Active comparator | Sayana Press, administered subcutaneously into anterior thigh Receives: Combination Product: Sayana Press |
| Sayana Press, abdomen | Active comparator | Sayana Press, administered subcutaneously into abdomen Receives: Combination Product: Sayana Press |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Trough Concentration (Ctrough) of Medroxyprogesterone
Measured: Day 92 post dose
Area under the curve from time zero to end of dosing interval (AUCtau)
Measured: pre-dose, up to 92 days post dose
Maximum Observed Serum Concentration (Cmax) of Medroxyprogesterone
Measured: pre-dose, up to 92 days post dose
Secondary outcomes (7)
Serum Progesterone Level
Measured: pre-dose, up to 99 days post dose
Serum Estradiol Level
Measured: pre-dose, up tp 99 days post dose
Serum Luteinizing Hormone (LH) Level
Measured: pre-dose, up to 99 days post dose
Serum Follicle-Stimulating Hormone (FSH) Level
Measured: pre-dose, up to 99 days post dose
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: 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
Measured: 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
Measured: Screening, Day 1, up to 150 days post dose or until study completion, whichever is longer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start16 Sep 2021
- Primary completion24 Jul 2025
- Study completion24 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893798
- Sponsor's protocol ID
- A6791042
- Other IDs
- 2024-513561-39-00
- Status last verified
- Aug 2025
- First submitted
- 14 May 2021
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04893798
- Acronym / sponsor ID
- A6791042
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 24 Jul 2025 (actual)
- Study completion
- 24 Jul 2025 (actual)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sayana Press, Upper Arm injection | Experimental | Combination Product: Sayana PressSayana Press, administered subcutaneously into upper arm |
| Sayana Press, anterior thigh | Active comparator | Combination Product: Sayana PressSayana Press, administered subcutaneously into anterior thigh |
| Sayana Press, abdomen | Active comparator | Combination Product: Sayana PressSayana Press, administered subcutaneously into abdomen |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sayana PressAlso: MedroxyprogesteroneSayana Press is a drug-device combination and is considered a medical product in the EU. | Combination product | Sayana Press, Upper Arm injection, Sayana Press, abdomen, Sayana Press, anterior thigh |
Primary outcome
Serum Trough Concentration (Ctrough) of Medroxyprogesterone
Time frame: Day 92 post dose
Area under the curve from time zero to end of dosing interval (AUCtau)
Time frame: pre-dose, up to 92 days post dose
Maximum Observed Serum Concentration (Cmax) of Medroxyprogesterone
Time frame: pre-dose, up to 92 days post dose
7 secondary outcomes
Serum Progesterone Level
Time frame: pre-dose, up to 99 days post dose
Serum Estradiol Level
Time frame: pre-dose, up tp 99 days post dose
Serum Luteinizing Hormone (LH) Level
Time frame: pre-dose, up to 99 days post dose
Serum Follicle-Stimulating Hormone (FSH) Level
Time frame: pre-dose, up to 99 days post dose
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.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sayana Press in people with Healthy, run by Pfizer at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Trough Concentration (Ctrough) of Medroxyprogesterone (time frame: Day 92 post dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.