MedTrace Logo

Sayana® Press Extension Study

NCT03154125 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2024-08-30

Study results available
· View outcomes & findings →

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.

Conditions

  • Contraception

Interventions

DRUG

Sayana® Press

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.

Sponsors & Collaborators

  • FHI 360

    lead OTHER

Principal Investigators

  • Vera Halpern, MD · FHI 360

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-22
Primary Completion
2020-05-30
Completion
2020-11-18

Countries

  • Brazil
  • Chile
  • Dominican Republic

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03154125 on ClinicalTrials.gov