NCT03034057

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

28 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

August 23, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2018

Completed
11 months until next milestone

Results Posted

Study results publicly available

October 18, 2019

Completed
Last Updated

October 18, 2019

Status Verified

September 1, 2019

Enrollment Period

1.3 years

First QC Date

January 24, 2017

Results QC Date

September 23, 2019

Last Update Submit

September 23, 2019

Conditions

Contraception

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Continuation Rate for the Method (Self-injection With Sayana Press) at 1 Year

    1 year

Study Arms (1)

sayana press

OTHER

single arm

Drug: Sayana Press

Interventions

Sayana PressDRUG

Sayana Press in the Uniject injection system

sayana press

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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;
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Fowey Clinical Research Office

Fowey, Cornwall, PL23 1DT, United Kingdom

Location

Fowey River Practice

Fowey, Cornwall, PL23 1DT, United Kingdom

Location

Brannel Surgery

St Austell, Cornwall, PL26 7RL, United Kingdom

Location

Rame Medical Ltd, Penntorr Health

Torpoint, Cornwall, PL11 2TB, United Kingdom

Location

Rame Medical Ltd

Torpoint, Cornwall, PL11 2TB, United Kingdom

Location

Knowle House Surgery

Plymouth, Devon, PL5 3JB, United Kingdom

Location

NHS Ayrshire & Arran, University Hospital Crosshouse

Kilmarnock, EAST Ayrshire, KA2 0BE, United Kingdom

Location

Trafalgar Medical Group Practice

Southsea, Hampshire, PO5 3ND, United Kingdom

Location

NHS Highland Clinical Research Facility

Inverness, Highland, IV2 3JH, United Kingdom

Location

Kent Community Health NHS Foundation Trust

Canterbury, KENT, CT1 3NG, United Kingdom

Location

Kent Community Health NHS Foundation Trust

Chatham, KENT, ME4 4DT, United Kingdom

Location

Southport & Ormskirk Hospital NHS Trust, The May Logan Healthy Living Centre

Liverpool, Merseyside, L205DQ, United Kingdom

Location

Southport & Ormskirk Hospital NHS Trust

Liverpool, Merseyside, L205DQ, United Kingdom

Location

NHS Lothian, Chalmers Sexual Health Centre

Edinburgh, Midlothian, EH3 9ES, United Kingdom

Location

NHS Ayrshire & Arran, Ayrshire Central Hospital

Irvine, North Ayrshire, KA 12 8SS, United Kingdom

Location

Pickering Medical Practice

Pickering, North Yorkshire, YO18 8BL, United Kingdom

Location

St Chad's Surgery

Radstock, Somerset, BA32UH, United Kingdom

Location

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, TYNE and WEAR, NE1 4LP, United Kingdom

Location

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, TYNE and WEAR, NE1 6ND, United Kingdom

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, WEST Midlands, B15 2TH, United Kingdom

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, WEST Midlands, B4 6DH, United Kingdom

Location

Eve Hill Medical Practice

Dudley, WEST Midlands, DY1 2QD, United Kingdom

Location

Bradford on Avon Health Centre

Bradford-on-Avon, Wiltshire, BA15 1DQ, United Kingdom

Location

Hathaway Medical Centre

Chippenham, Wiltshire, SN14 6GT, United Kingdom

Location

Trowbridge Health Centre

Trowbridge, Wiltshire, BA148QA, United Kingdom

Location

Westbury Group Practice

Westbury, Wiltshire, BA13 3FQ, United Kingdom

Location

CPS Research

Glasgow, G20 0XA, United Kingdom

Location

Homerton University Hospital NHS Foundation Trust, Homerton

London, E9 6SR, United Kingdom

Location

Related Links

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2017

First Posted

January 27, 2017

Study Start

August 23, 2017

Primary Completion

December 7, 2018

Study Completion

December 7, 2018

Last Updated

October 18, 2019

Results First Posted

October 18, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

More information

Locations

GB(28)