Sayana® Press Extension Study
Condition: Contraception
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Sayana® Press
Intervention type(s): Drug
Intervention description(s): 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.
Other intervention name(s): medroxyprogesterone acetate (MPA) injectable suspension
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All participants will receive the same study drug, Sayana® Press. However, women will be randomized to receive their injections in the abdomen, back of the upper arm, or upper thigh to control for potential confounding when assessing relationships between SC injection site, efficacy, and PK. One cohort of N=630 women will be randomized 1:1 to receive their injections in the abdomen or thigh, and a separate PK cohort of N=120 women agreeing to MPA testing will be randomized 1:1:1 to receive their injections in the abdomen, upper thigh, or back of the upper arm. Randomization will be stratified by cohort and site using appropriate randomly permuted block sizes.
Masking: Single (Outcomes Assessor)
Primary purpose: Other