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Sayana Press UK Self-Injection Study

Last updated on December 6, 2019

FOR MORE INFORMATION
Study Location
Fowey Clinical Research Office
Fowey, Cornwall, PL23 1DT United Kingdom
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Contraception
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT03034057
Pfizer
Completed
Sayana Press UK Self-Injection Study

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Descriptive Information
Brief Title  ICMJE Sayana Press UK Self-Injection Study
Official Title  ICMJE 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
Brief Summary A one-year evaluation of Sayana Press self injection in women of reproductive age in the United Kingdom (UK).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Contraception
Intervention  ICMJE Drug: Sayana Press
Sayana Press in the Uniject injection system
Study Arms  ICMJE sayana press
single arm
Intervention: Drug: Sayana Press
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 18, 2018)
169
Original Estimated Enrollment  ICMJE
 (submitted: January 24, 2017)
160
Actual Study Completion Date  ICMJE December 7, 2018
Actual Primary Completion Date December 7, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03034057
Other Study ID Numbers  ICMJE A6791040
2017-000051-13 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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/da....
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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