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Sayana Press UK Self-Injection Study

Last updated on December 15, 2017

About this Study

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

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
Recruiting
Sayana Press UK Self-Injection Study

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Pfizer Clinical Trials Contact Center

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[email protected]

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Sayana Press UK Self-Injection Study
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).
Not Provided
Interventional
Phase 4
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Contraception
Drug: Sayana Press
Sayana Press in the Uniject injection system
sayana press
single arm
Intervention: Drug: Sayana Press
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
December 14, 2018
December 14, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
18 Years to 45 Years   (Adult)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United Kingdom
 
 
NCT03034057
A6791040
2017-000051-13 ( EudraCT Number )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

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 thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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