Sayana Press UK Self-Injection Study

September 23, 2019 updated by: Pfizer

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
169

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: sayana press
single arm
Drug: Sayana Press
Sayana Press in the Uniject injection system

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 1 year
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.
Up to 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Continuation Rate for the Method (Self-injection With Sayana Press) at 1 Year
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 23, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 7, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 7, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A6791040
  • 2017-000051-13 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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