Sayana® Press Extension Study

• Register: ClinicalTrials.gov
• Last refreshed on: 11 January 2021
• Main ID: NCT03154125
• Date of registration: 12/05/2017
• Prospective Registration: Yes
• Primary sponsor: FHI 360
• Public title: Sayana® Press Extension Study
• Scientific title: A Study to Evaluate the Effectiveness, Pharmacokinetics, Safety, and Acceptability of Sayana® Press When Injected Every Four Months
• Date of first enrolment: September 22, 2017
• Target sample size: 750
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03154125
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Single (Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Brazil, Chile, Dominican Republic

Contacts

• Name: Jennifer Deese, PhD, MPH
• Affiliation: FHI 360

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

- 18 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

Exclusion Criteria:

- 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.



Age minimum: 18 Years
Age maximum: 35 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Contraception

Intervention(s)

Drug: Sayana® Press

Primary Outcome(s)

Occurrence of pregnancy [Time Frame: 12 months after treatment initiation]

Secondary Outcome(s)

Occurrence of serious adverse events (SAEs) and adverse events (AEs) leading to product withdrawal [Time Frame: 12 months after treatment initiation]

Serum MPA concentrations (trough concentrations, accumulation and apparent terminal half-life of MPA) in a subset of 120 participants [Time Frame: 12 months after treatment initiation]

Acceptability of Sayana® Press [Time Frame: 12 months after treatment initiation]

Secondary ID(s)

926400

Source(s) of Monetary Support

Please refer to primary and secondary sponsors