At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 169 enrolled
Drug / intervention
Sayana Pressdrug
Likely dose
Sayana Press (DMPA medroxyprogesterone acetate) in Uniject injection system — specific dose not stated in protocolAI-extracted
Key inclusion· 4
- ✓Women aged 18–45 years willing to attempt Sayana Press self-injection at home
- ✓Investigator assessment that woman is likely to be successful on DMPA self-injection program
- ✓Planning to remain in area for at least 12 months
- ✓Willing to be contacted by clinical staff at work or home and comply with study visits and procedures
Key exclusion· 12
- ✕Hypersensitivity to medroxyprogesterone acetate (MPA) or Sayana Press constituents
- ✕Known or suspected malignancy of genital organs or breast
- ✕History of cerebrovascular disease (stroke, transient ischaemic attack)
- ✕Metabolic bone disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Sayana Press for Contraception. Completed, enrolled 169 participants across 28 sites.
Detailed Summary
A one-year evaluation of Sayana Press self injection in women of reproductive age in the United Kingdom (UK).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContraception
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 2017
Enrollment StartAug 2017
Primary CompletionDec 2018
TodayJul 2026
First PostedJan 27, 2017
Enrollment StartAug 23, 2017
Primary CompletionDec 7, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9.4 years ago
Interventions
Sayana Pressdrug
Sayana Press in the Uniject injection system