Sayana® Press Extension Study

NCT03154125 | Completed Phase 3 Results DMC

• 1 other identifier: 926400
• Study Type: interventional
• Target: 750
• Locations: 3 countries
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• Occurrence of Pregnancy

  Pregnancy is defined as having a positive urine pregnancy test. Positive urine tests will be confirmed by ultrasound and/or serum hCG testing whenever possible. The primary efficacy analysis will be based on the pregnancy Pearl Index, computed as the number of pregnancies that occur during the treatment period multiplied by 100 and divided by the number of WY of treatment contributed to the Treated Analysis Set among women receiving injections in the abdomen or thigh.

  12 months after treatment initiation

Secondary Outcomes (3)

• Serum MPA Concentrations in a Subset of 120 Participants

  2, 3, 4, 8, and 12 months after treatment initiation

• Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal

  12 months after treatment initiation

• Acceptability of Sayana® Press

  12 months after treatment initiation

Other Outcomes (1)

• Return to Ovulation After 12 Months of Use of Sayana Press When Injected Every Four Months.

  A maximum of 12 months from the last study injection.

Study Arms (3)

Abdomen

EXPERIMENTAL

Sayana® Press (MPA injectable suspension, 104 mg/0.65 mL, pre-filled in the UnijectTM delivery injection system) injected subcutaneously every 4 months (17-18 weeks) for 3 treatment cycles (12 months).

Drug: Sayana® Press

Upper thigh

EXPERIMENTAL

Sayana® Press (MPA injectable suspension, 104 mg/0.65 mL, pre-filled in the UnijectTM delivery injection system) injected subcutaneously every 4 months (17-18 weeks) for 3 treatment cycles (12 months).

Drug: Sayana® Press

Back of the upper arm

EXPERIMENTAL

Sayana® Press (MPA injectable suspension, 104 mg/0.65 mL, pre-filled in the UnijectTM delivery injection system) injected subcutaneously every 4 months (17-18 weeks) for 3 treatment cycles (12 months).

Drug: Sayana® Press

Interventions

Sayana® Press DRUG

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.

Also known as: medroxyprogesterone acetate (MPA) injectable suspension

Abdomen; Back of the upper arm; Upper thigh

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• not pregnant and no desire to become pregnant in the next 18 months
• regular menstrual cycles (25 to 35 days in length when not using hormonal contraception, pregnant, or lactating)
• at risk of pregnancy (no diagnosis of infertility, no history of tubal ligation or hysterectomy, and an average of 1 or more unprotected acts of vaginal intercourse per month)
• in good general health as determined by a medical history
• to 35 years of age, inclusive
• willing to provide informed consent, follow all study requirements, and rely on Sayana® Press injected every 4 months as the only means of contraception for 12 months
• has only one sexual partner and expects to have that same sexual partner for the next 12 months

You may not qualify if:

• has a primary partner who has received a vasectomy or is otherwise sterile
• medical contraindications to depot medroxyprogesterone acetate (DMPA) per World Health Organization medical eligibility criteria for contraceptive use
• known HIV-infection (for her or her partner)
• diagnosis or treatment for a sexually transmitted infection in the past month (for her or a partner), excluding recurrent herpes or condyloma
• received an injection of a progestin-only containing contraceptive (DMPA or norethisterone enanthate) in the past 12 months
• received an injection of a combined injectable contraceptive in the past 6 months
• known or suspected allergic reaction to DMPA
• used a levonorgestrel-releasing intrauterine system, NuvaRing, contraceptive patch, oral contraceptives or a contraceptive implant in the 7 days prior to enrollment (PK cohort only)
• previous (within 1 month prior to enrollment), current or planned (in the next 12 months) use of an investigational drug, prohibited drug per protocol or other drug which in the opinion of the site investigator could complicate study findings
• has been pregnant in the past month
• is lactating
• plans to move to another location in the next 12 months
• has a social or medical condition which in the opinion of the site investigator would make study participation unsafe, or interfere with adherence to protocol requirements.

Sponsors & Collaborators

• FHI 360: lead

Study Sites (3)

Universidade Estadual de Campinas (UNICAMP)

Campinas, 13084-971, Brazil

Location

Instituto Chileno De Medicina Reproductiva (ICMER)

Santiago, Chile

Location

Asociación Dominicana Pro Bienestar de la Familia, Inc. (PROFAMILIA)

Santo Domingo, Dominican Republic

Location

Related Publications (2)

• Burke HM, Packer C, Fuchs R, Brache V, Bahamondes L, Salinas A, Veiga N, Miller A, Deese J. Acceptability of the contraceptive Sayana(R) Press when injected every four months: Results from a twelve-month trial in Brazil, Chile and the Dominican Republic. Contraception. 2022 Sep;113:95-100. doi: 10.1016/j.contraception.2022.04.007. Epub 2022 Apr 26.

  PMID: 35483431 DERIVED

• Deese J, Brache V, Bahamondes L, Salinas A, Jorge A, Veiga N Jr, Fuchs R, Miller A, Taylor D, Halpern V, Dorflinger L. Contraceptive effectiveness, pharmacokinetics, and safety of Sayana(R) Press when injected every four months: a multicenter phase 3 trial. EClinicalMedicine. 2022 Jan 29;44:101273. doi: 10.1016/j.eclinm.2022.101273. eCollection 2022 Feb.

  PMID: 35128365 DERIVED

MeSH Terms

Interventions

Medroxyprogesterone Acetate

Intervention Hierarchy (Ancestors)

Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Vera Halpern, M.D., Director of Clinical Development
• Organization: FHI 360

VHalpern@fhi360.org

+1 (919) 321-3331

Study Officials

• Vera Halpern, MD

  FHI 360

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Neither participants nor site staff will be blinded to SC injection sites. However, laboratory staff analyzing serum MPA specimens and staff at FHI 360 responsible for adjudicating pregnancy outcomes and coding adverse events will be blinded to individual participant injection site assignments for the duration of each participant's follow up.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: May 16, 2017
• Study Start: September 22, 2017
• Primary Completion: May 30, 2020
• Study Completion: November 18, 2020
• Last Updated: August 30, 2024
• Results First Posted: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Within 30 calendar days after the dataset is first used to produce an Intellectual Work

Locations

DO (1); CL (1); BR (1)