Clinical trial NCT03034057: Sayana Press UK Self-Injection Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraception
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-01-27
Enrollment: 169
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Successful Self-Injections Performed of All Attempts at Home on Schedule (Full Analysis Set)
timeFrame: Up to 1 year
measure: Percentage of Successful Self-Injections Performed of All Attempts at Home on Schedule (Sensitivity Analysis)
timeFrame: Up to 1 year
Secondary outcomes:
measure: Continuation Rate for the Method (Self-injection With Sayana Press) at 1 Year
timeFrame: 1 year
Other outcomes:
Locations:
city: Fowey
country: United Kingdom
facility: Fowey Clinical Research Office
state: Cornwall
city: Fowey
country: United Kingdom
facility: Fowey River Practice
state: Cornwall
city: Saint Austell
country: United Kingdom
facility: Brannel Surgery
state: Cornwall
city: Torpoint
country: United Kingdom
facility: Rame Medical Ltd, Penntorr Health
state: Cornwall
city: Torpoint
country: United Kingdom
facility: Rame Medical Ltd
state: Cornwall
city: Plymouth
country: United Kingdom
facility: Knowle House Surgery
state: Devon
city: Kilmarnock
country: United Kingdom
facility: NHS Ayrshire & Arran, University Hospital Crosshouse
state: EAST Ayrshire
city: Southsea
country: United Kingdom
facility: Trafalgar Medical Group Practice
state: Hampshire
city: Inverness
country: United Kingdom
facility: NHS Highland Clinical Research Facility
state: Highland
city: Canterbury
country: United Kingdom
facility: Kent Community Health NHS Foundation Trust
state: Kent
city: Chatham
country: United Kingdom
facility: Kent Community Health NHS Foundation Trust
state: Kent
city: Liverpool
country: United Kingdom
facility: Southport & Ormskirk Hospital NHS Trust, The May Logan Healthy Living Centre
state: Merseyside
city: Liverpool
country: United Kingdom
facility: Southport & Ormskirk Hospital NHS Trust
state: Merseyside
city: Edinburgh
country: United Kingdom
facility: NHS Lothian, Chalmers Sexual Health Centre
state: Midlothian
city: Irvine
country: United Kingdom
facility: NHS Ayrshire & Arran, Ayrshire Central Hospital
state: North Ayrshire
city: Pickering
country: United Kingdom
facility: Pickering Medical Practice
state: North Yorkshire
city: Radstock
country: United Kingdom
facility: St Chad's Surgery
state: Somerset
city: Newcastle upon Tyne
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust
state: Tyne and Wear
city: Newcastle upon Tyne
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust
state: Tyne and Wear
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
state: WEST Midlands
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
state: WEST Midlands
city: Dudley
country: United Kingdom
facility: Eve Hill Medical Practice
state: WEST Midlands
city: Bradford on Avon
country: United Kingdom
facility: Bradford on Avon Health Centre
state: Wiltshire
city: Chippenham
country: United Kingdom
facility: Hathaway Medical Centre
state: Wiltshire
city: Trowbridge
country: United Kingdom
facility: Trowbridge Health Centre
state: Wiltshire
city: Westbury
country: United Kingdom
facility: Westbury Group Practice
state: Wiltshire
city: Glasgow
country: United Kingdom
facility: CPS Research
city: London
country: United Kingdom
facility: Homerton University Hospital NHS Foundation Trust, Homerton
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: