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Sayana Press UK Self-Injection Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03034057
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment Phase
Contraception Drug: Sayana Press Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 169 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : August 23, 2017
Actual Primary Completion Date : December 7, 2018
Actual Study Completion Date : December 7, 2018

Arm Intervention/treatment
sayana press
single arm
Drug: Sayana Press
Sayana Press in the Uniject injection system




Primary Outcome Measures :
  1. the proportion of all attempted home self-injections that were successfully performed by the study participant at home (ie, not in the clinic under direct HCP supervision) and on schedule (13 week interval +/- 1 week). [ Time Frame: 1 year ]
    The primary endpoint will be the proportion of all attempted home self-injections that were successfully performed by the study participant at home (ie, not in the clinic under direct HCP supervision) and on schedule (13 week interval +/- 1 week). If a subject decides to discontinue Sayana Press as her contraceptive method, and therefore does not attempt one or more injections, these scheduled injections would not be included in the denominator for the primary endpoint


Secondary Outcome Measures :
  1. continuation rate of Sayana Press over a one year period [ Time Frame: 1 year ]
    continuation rate of Sayana Press for one year



Information from the National Library of Medicine

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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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034057


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

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03034057     History of Changes
Other Study ID Numbers: A6791040
2017-000051-13 ( EudraCT Number )
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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