Sayana Press UK Self-Injection Study

Contraception Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03034057
• Other study ID #: A6791040
• Secondary ID: 2017-000051-13
• Status: Completed
• Phase: Phase 4
• Start date: August 23, 2017
• Est. completion date: December 7, 2018

Study information

• Verified date: September 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: December 7, 2018
• Est. primary completion date: December 7, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Sayana Press
Sayana Press in the Uniject injection system

Locations

Country	Name	City	State
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham	WEST Midlands
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham	WEST Midlands
United Kingdom	Bradford on Avon Health Centre	Bradford on Avon	Wiltshire
United Kingdom	Kent Community Health NHS Foundation Trust	Canterbury	Kent
United Kingdom	Kent Community Health NHS Foundation Trust	Chatham	Kent
United Kingdom	Hathaway Medical Centre	Chippenham	Wiltshire
United Kingdom	Eve Hill Medical Practice	Dudley	WEST Midlands
United Kingdom	NHS Lothian, Chalmers Sexual Health Centre	Edinburgh	Midlothian
United Kingdom	Fowey Clinical Research Office	Fowey	Cornwall
United Kingdom	Fowey River Practice	Fowey	Cornwall
United Kingdom	CPS Research	Glasgow
United Kingdom	NHS Highland Clinical Research Facility	Inverness	Highland
United Kingdom	NHS Ayrshire & Arran, Ayrshire Central Hospital	Irvine	North Ayrshire
United Kingdom	NHS Ayrshire & Arran, University Hospital Crosshouse	Kilmarnock	EAST Ayrshire
United Kingdom	Southport & Ormskirk Hospital NHS Trust	Liverpool	Merseyside
United Kingdom	Southport & Ormskirk Hospital NHS Trust, The May Logan Healthy Living Centre	Liverpool	Merseyside
United Kingdom	Homerton University Hospital NHS Foundation Trust, Homerton	London
United Kingdom	The Newcastle upon Tyne Hospitals NHS Foundation Trust	Newcastle upon Tyne	Tyne and Wear
United Kingdom	The Newcastle upon Tyne Hospitals NHS Foundation Trust	Newcastle upon Tyne	Tyne and Wear
United Kingdom	Pickering Medical Practice	Pickering	North Yorkshire
United Kingdom	Knowle House Surgery	Plymouth	Devon
United Kingdom	St Chad's Surgery	Radstock	Somerset
United Kingdom	Brannel Surgery	Saint Austell	Cornwall
United Kingdom	Trafalgar Medical Group Practice	Southsea	Hampshire
United Kingdom	Rame Medical Ltd	Torpoint	Cornwall
United Kingdom	Rame Medical Ltd, Penntorr Health	Torpoint	Cornwall
United Kingdom	Trowbridge Health Centre	Trowbridge	Wiltshire
United Kingdom	Westbury Group Practice	Westbury	Wiltshire

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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

External Links

•   To obtain contact information for a study center near you, click here.