At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 750 enrolled
Drug / intervention
Sayana® Pressdrug
Likely dose
Sayana® Press 104 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study to Evaluate the Effectiveness, Pharmacokinetics, Safety, and Acceptability of Sayana® Press When Injected Every Four Months
In Brief
A Phase 3 clinical trial evaluating Sayana® Press for Contraception. Completed, enrolled 750 participants across 3 sites in 3 countries.
Detailed Summary
This is a randomized clinical trial designed to evaluate the effectiveness, safety and acceptability of Sayana® Press when injected every 4 months (17-18 weeks) for 3 treatment cycles (12 months) of use.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContraception
CountriesBrazil, Chile, Dominican Republic
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMay 2017
Enrollment StartSep 2017
Primary CompletionMay 2020
Study CompletionNov 2020
TodayJul 2026
First PostedMay 16, 2017
Enrollment StartSep 22, 2017
Primary CompletionMay 30, 2020
Study CompletionNov 18, 2020
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.1 years ago
Interventions
Sayana® Pressdrug
The active ingredient in Sayana® Press is Medroxyprogesterone acetate (MPA). Sayana® Press (MPA injectable suspension, 104 mg/0.65 mL, pre-filled in the UnijectTM delivery injection system) for subcutaneous injection.