NCT03154125

Sayana® Press Extension Study

A Study to Evaluate the Effectiveness, Pharmacokinetics, Safety, and Acceptability of Sayana® Press When Injected Every Four Months

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 750 (actual)
• Sponsor: FHI 360 · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a randomized, partially-blinded, multi-center, parallel-group study to evaluate the effectiveness, PK, safety, and acceptability of Sayana® Press when injected every 4 months (17-18 weeks) rather than the currently prescribed 3-month (12-14 weeks) regimen. A total of 750 healthy, sexually active women aged 18 to 35 years with regular menstrual cycles and no DMPA use in the previous 12 months will be enrolled and followed for pregnancy. Among all enrolled, 710 will be randomized to receive injections in the abdomen or upper thigh in accordance with the PATH Sayana® injection instructions, which are consistent with prescribing information, for the primary effectiveness analysis. An additional 40 women will be randomized to receive injections subcutaneously in the back of the upper arm to assess whether differences in PK may exist which could impact the grace period for reinjections for that injection site. A single MPA serum sample will be collected from all participants at baseline. All participants will receive re-injections at month 4 and month 8, and complete their scheduled follow-up at month 12. There will be a plus 7-day grace period for re-injections, but women who are up to 28 days late may continue treatment if they have a negative urine pregnancy test. Urine pregnancy testing will be performed at month 4, at study exit and at any other time during the study if clinically indicated. Participants will be evaluated for injection site reactions and asked to provide information on adverse events, prohibited concomitant medication and other contraceptive use, vaginal bleeding, and method acceptability at all regular follow-up visits (i.e., not including the PK visits at Months 2 and 3). Serious adverse events and adverse events leading to product withdrawal, will be recorded throughout the study.

Conditions

• Contraception

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-09-22
• Primary completion: 2020-05-30
• Completion: 2020-11-18
• First posted: 2017-05-16
• Last updated: 2024-08-30
• Results posted: 2024-08-30

Locations

3 sites across 3 countries: Brazil, Chile, Dominican Republic