Phase 3
N=750
Sayana® Press Extension Study
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT03154125 ↗Enrolled (actual)
750
Serious AEs
0.3%
Results posted
Aug 2024
Primary outcome: Primary: Occurrence of Pregnancy — 0; 0 Pregnancies per 100 women years
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sayana® Press (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- FHI 360
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of Pregnancy |
0; 0 | — |
| SECONDARY Serum MPA Concentrations in a Subset of 120 Participants |
0.503; 0.355; 0.490; 0.367; 0.328; 0.337 | — |
| SECONDARY Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal |
0; 2; 0; 1; 0; 0 | — |
| SECONDARY Acceptability of Sayana® Press |
306; 313; 34; 22; 23; 4 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03154125). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.