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Trial record 1 of 1 for:    NCT03034057
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Sayana Press UK Self-Injection Study

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ClinicalTrials.gov Identifier: NCT03034057
Recruitment Status : Completed
First Posted : January 27, 2017
Results First Posted : October 18, 2019
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE January 24, 2017
First Posted Date  ICMJE January 27, 2017
Results First Submitted Date  ICMJE September 23, 2019
Results First Posted Date  ICMJE October 18, 2019
Last Update Posted Date October 18, 2019
Actual Study Start Date  ICMJE August 23, 2017
Actual Primary Completion Date December 7, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2019)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
continuation rate of Sayana Press over a one year period [ Time Frame: 1 year ]
continuation rate of Sayana Press for one year
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
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