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).

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.