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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 169
- 试验地点
- 25
- 主要终点
- Percentage of Successful Self-Injections Performed of All Attempts at Home on Schedule (Full Analysis Set)
研究概览
简要总结
A one-year evaluation of Sayana Press self injection in women of reproductive age in the United Kingdom (UK).
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
sayana press
single arm
干预措施: Sayana Press (Drug)
结局指标
主要结局
Percentage of Successful Self-Injections Performed of All Attempts at Home on Schedule (Full Analysis Set)
时间窗: 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)
时间窗: 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.
次要结局
- Continuation Rate for the Method (Self-injection With Sayana Press) at 1 Year(1 year)