Sayana Press UK Self-Injection Study

A Phase 4 study testing Sayana Press in people with Contraception, run by Pfizer at 28 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

A one-year evaluation of Sayana Press self injection in women of reproductive age in the United Kingdom (UK). 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: Contraception
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: 169 participants
Where: 28 sitesUnited Kingdom
Study dates: 23 Aug 2017to 7 Dec 2018
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

women aged 18 to 45 years of age who are willing to attempt Sayana Press self-injection at home;
women who are likely to be successful on a DMPA self-injection program, based on the opinion of the investigator;
not planning to move out of the area for at least 12 months;
willing to be contacted by the clinical staff at work or at home;
evidence of a personally signed and dated Informed Consent Document (ICD) indicating that the subject has been informed of all pertinent aspects of the study;
subjects who are willing and able to comply with scheduled visits, treatment plan and other study procedures

Who cannot join

a pre-existing medical condition that would interfere with participation in the study or pose a risk to the subject, including hypersensitivity to MPA or any constituents of Sayana Press;
known or suspected malignancy of genital organs;
known or suspected malignancy of the breast;
history of cerebrovascular disease
metabolic bone disease
a contraindication to DMPA (UK Medical Eligibility Criteria Category 3 or 4) such as:

Show all 21Show fewer

Multiple risk factors for cardiovascular disease (e.g. older age, smoking, diabetes, obesity, hypertension)
current and history of ischaemic heart disease;
stroke (history of cerebrovascular accident, including transient ischaemic attack);
unexplained vaginal bleeding;
current or history of breast cancer;
diabetic nephropathy, neuropathy, retinopathy or other diabetic vascular disease;
severe (decompensated) liver cirrhosis;
hepatocellular adenoma;
hepatoma;
Systemic Lupus Erythematosus (positive or unknown antiphospholipid antibodies; severe thrombocytopenia;
subjects who are investigational centre staff members directly involved in the conduct of the study and their family members, centre staff members otherwise supervised by the investigator, or subjects who are Pfizer employees involved in the conduct of the study;
participation in other studies involving investigational drug(s) within 30 days prior to study entry and/or during study participation;
patients who plan to get pregnant within two years of study;
breastfeeding and pregnant subjects;
other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the subject inappropriate for entry into this study.

Trial locations and contacts

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

United Kingdom28 sites

University Hospitals Birmingham NHS Foundation Trust
Birmingham, WEST Midlands, B15 2TH
University Hospitals Birmingham NHS Foundation Trust
Birmingham, WEST Midlands, B4 6DH
Bradford on Avon Health Centre
Bradford on Avon, Wiltshire, BA15 1DQ
Kent Community Health NHS Foundation Trust
Canterbury, KENT, CT1 3NG
Kent Community Health NHS Foundation Trust
Chatham, KENT, ME4 4DT
Hathaway Medical Centre
Chippenham, Wiltshire, SN14 6GT
Eve Hill Medical Practice
Dudley, WEST Midlands, DY1 2QD
NHS Lothian, Chalmers Sexual Health Centre
Edinburgh, Midlothian, EH3 9ES
Fowey Clinical Research Office
Fowey, Cornwall, PL23 1DT
Fowey River Practice
Fowey, Cornwall, PL23 1DT
CPS Research
Glasgow, G20 0XA
NHS Highland Clinical Research Facility
Inverness, Highland, IV2 3JH
NHS Ayrshire & Arran, Ayrshire Central Hospital
Irvine, North Ayrshire, KA 12 8SS
NHS Ayrshire & Arran, University Hospital Crosshouse
Kilmarnock, EAST Ayrshire, KA2 0BE
Southport & Ormskirk Hospital NHS Trust, The May Logan Healthy Living Centre
Liverpool, Merseyside, L205DQ
Southport & Ormskirk Hospital NHS Trust
Liverpool, Merseyside, L205DQ
Homerton University Hospital NHS Foundation Trust, Homerton
London, E9 6SR
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, TYNE and WEAR, NE1 4LP
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, TYNE and WEAR, NE1 6ND
Pickering Medical Practice
Pickering, North Yorkshire, YO18 8BL
Knowle House Surgery
Plymouth, Devon, PL5 3JB
St Chad's Surgery
Radstock, Somerset, BA32UH
Trafalgar Medical Group Practice
Southsea, Hampshire, PO5 3ND
Brannel Surgery
St Austell, Cornwall, PL26 7RL
Rame Medical Ltd, Penntorr Health
Torpoint, Cornwall, PL11 2TB
Rame Medical Ltd
Torpoint, Cornwall, PL11 2TB
Trowbridge Health Centre
Trowbridge, Wiltshire, BA148QA
Westbury Group Practice
Westbury, Wiltshire, BA13 3FQ

Other trials in United Kingdom

About this study

Official title: PHASE IV OPEN LABEL SINGLE GROUP ONE YEAR STUDY OF HOME SELF-INJECTION WITH SAYANA (REGISTERED) PRESS IN ADULT WOMEN OF REPRODUCTIVE AGE - A PRAGMATIC CLINICAL TRIAL

A one-year evaluation of Sayana Press self injection in women of reproductive age in the United Kingdom (UK).

Conditions: Contraception
Being tested: Sayana Press

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sayana PressDrug
Sayana Press in the Uniject injection system

Study groups in NCT03034057
Study group	Role	What they receive
sayana press	Other	single arm Receives: Drug: Sayana Press

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Successful Self-Injections Performed of All Attempts at Home on Schedule (Full Analysis Set)
Each participant had a maximum of 3 home self-injections, each of which was defined as a success or failure. A success was defined as a home self-injection that was successfully performed by the participant at home and on schedule (13 week interval +/- 1 week) where all attempts were included in the denominator. If the participant attempted but was unable to administer the self-injection at home and had it performed instead at the clinic, then these were classed as failures. This outcome measure was analyzed by generalized estimating equation (GEE) model using participant as the clustering variable. The GEE model used the logit link and contained an intercept term. The 95% confidence interval (CI) for the intercept was transformed to a 95% CI for the self-injection success rate.
Measured: Up to 1 year
Percentage of Successful Self-Injections Performed of All Attempts at Home on Schedule (Sensitivity Analysis)
Each participant had a maximum of 3 home self-injections, each of which was defined as a success or failure. A success was defined as a home self-injection that was successfully performed by the participant at home and on schedule (13 week interval +/- 1 week) where all attempts were included in the denominator. If the participant attempted but was unable to administer the self-injection at home and had it performed instead at the clinic, then these were classed as failures. This outcome measure was analyzed by GEE model using participant as the clustering variable. The GEE model used the logit link and contained an intercept term. The 95% CI for the intercept was transformed to a 95% CI for the self-injection success rate. The sensitivity analysis was conducted to eliminate the data from the discontinued site due to ongoing Good Clinical Practice (GCP) violations.
Measured: Up to 1 year

Secondary outcomes (1)

Continuation Rate for the Method (Self-injection With Sayana Press) at 1 Year
Continuation rate for the method at 1 year equals: ([the number of participants who received all 4 injections and had not discontinued by 12 months] / [total number of participants in the study]) *100%. A 95% CI was calculated along with the continuation rate using normal approximation to the binominal.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Aug 20177 Dec 2018

First posted27 Jan 2017 (estimated)
Study start23 Aug 2017
Primary completion7 Dec 2018
Study completion7 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ContraceptionStudies 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 4
Primary purpose: Prevention
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 169 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03034057
Sponsor's protocol ID: A6791040
Other IDs: 2017-000051-13, 2017
Status last verified: Sep 2019
First submitted: 24 Jan 2017
Last updated: 18 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Contraception trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PHASE IV OPEN LABEL SINGLE GROUP ONE YEAR STUDY OF HOME SELF-INJECTION WITH SAYANA (REGISTERED) PRESS IN ADULT WOMEN OF REPRODUCTIVE AGE - A PRAGMATIC CLINICAL TRIAL
ClinicalTrials.gov ID: NCT03034057
Acronym / sponsor ID: A6791040
Conditions: Contraception
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 169 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 23 Aug 2017 (actual)
Primary completion: 7 Dec 2018 (actual)
Study completion: 7 Dec 2018 (actual)
First posted: 27 Jan 2017 (estimated)
Results: Posted 18 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A one-year evaluation of Sayana Press self injection in women of reproductive age in the United Kingdom (UK).

Study design

Primary purpose: Prevention
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
sayana press	Other	Drug: Sayana Presssingle arm

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

women aged 18 to 45 years of age who are willing to attempt Sayana Press self-injection at home;
women who are likely to be successful on a DMPA self-injection program, based on the opinion of the investigator;
not planning to move out of the area for at least 12 months;
willing to be contacted by the clinical staff at work or at home;
evidence of a personally signed and dated Informed Consent Document (ICD) indicating that the subject has been informed of all pertinent aspects of the study;

Key exclusion criteria (21 listed)

a pre-existing medical condition that would interfere with participation in the study or pose a risk to the subject, including hypersensitivity to MPA or any constituents of Sayana Press;
known or suspected malignancy of genital organs;
known or suspected malignancy of the breast;
history of cerebrovascular disease
metabolic bone disease

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 PressSayana Press in the Uniject injection system	Drug	sayana press

Primary outcome

Percentage of Successful Self-Injections Performed of All Attempts at Home on Schedule (Full Analysis Set)
Time frame: Up to 1 year
Each participant had a maximum of 3 home self-injections, each of which was defined as a success or failure. A success was defined as a home self-injection that was successfully performed by the participant at home and on schedule (13 week interval +/- 1 week) where all attempts were included in the denominator. If the participant attempted but was unable to administer the self-injection at home and had it performed instead at the clinic, then these were classed as failures. This outcome measure was analyzed by generalized estimating equation (GEE) model using participant as the clustering variable. The GEE model used the logit link and contained an intercept term. The 95% confidence interval (CI) for the intercept was transformed to a 95% CI for the self-injection success rate.
Percentage of Successful Self-Injections Performed of All Attempts at Home on Schedule (Sensitivity Analysis)
Time frame: Up to 1 year
Each participant had a maximum of 3 home self-injections, each of which was defined as a success or failure. A success was defined as a home self-injection that was successfully performed by the participant at home and on schedule (13 week interval +/- 1 week) where all attempts were included in the denominator. If the participant attempted but was unable to administer the self-injection at home and had it performed instead at the clinic, then these were classed as failures. This outcome measure was analyzed by GEE model using participant as the clustering variable. The GEE model used the logit link and contained an intercept term. The 95% CI for the intercept was transformed to a 95% CI for the self-injection success rate. The sensitivity analysis was conducted to eliminate the data from the discontinued site due to ongoing Good Clinical Practice (GCP) violations.

1 secondary outcome

Continuation Rate for the Method (Self-injection With Sayana Press) at 1 Year
Time frame: 1 year

Results and safety

Results posted to the registry on 18 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sayana Press	169	114

Primary outcome: Percentage of Successful Self-Injections Performed of All Attempts at Home on Schedule (Full Analysis Set)

Time frame: Up to 1 year. Number (95% Confidence Interval). Unit: Percentage of all attempts at home

Measure	Sayana Press n = 169
Value	88.8 (85.1 to 91.6)

Population analysed: The analysis population included participants who enrolled into the study.

Primary outcome: Percentage of Successful Self-Injections Performed of All Attempts at Home on Schedule (Sensitivity Analysis)

Time frame: Up to 1 year. Number (95% Confidence Interval). Unit: Percentage of all attempts at home

Measure	Sayana Press n = 164
Value	89.3 (85.6 to 92.1)

Population analysed: The analysis population included participants who enrolled into the study. Participants at sites which required closure during study due to GCP violations were excluded from the analysis population.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sayana Press	5 of 169 (3%)	60 of 169 (35.5%)	0 of 169

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. 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

28 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sayana Press in people with Contraception, run by Pfizer at 28 sites in United Kingdom.

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 6 inclusion and 21 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 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Successful Self-Injections Performed of All Attempts at Home on Schedule (Full Analysis Set) (time frame: Up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03034057.

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 18 Oct 2019; AzTrials last refreshed its copy on 28 Oct 2026.