Sayana Press UK Self-Injection Study

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

Official Title
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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

Conditions
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Contraception

Intervention / Treatment
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* Drug: Sayana Press


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: sayana press<br>single arm | Drug: Sayana Press<br>* Sayana Press in the Uniject injection system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Successful Self-Injections Performed of All Attempts at Home on Schedule (Full Analysis Set) | 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) | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuation Rate for the Method (Self-injection With Sayana Press) at 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 |