Adults 18 to 35, female only, with Contraception. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Occurrence of PregnancyPrimary· 12 months after treatment initiation
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.
Group
Value
95% CI
Abdomen
0
0 – 1.18
Upper Thigh
0
0 – 1.17
Serum MPA Concentrations in a Subset of 120 ParticipantsSecondary· 2, 3, 4, 8, and 12 months after treatment initiation
Pharmacokinetic endpoints include serum MPA concentrations at month 2, 3, 4, 8, and 12.
Trough concentration at Month 2
Group
Value
95% CI
Abdomen
0.503
± 0.263
Upper Thigh
0.355
± 0.155
Back of the Upper Arm
0.490
± 0.264
Trough concentration at Month 3
Group
Value
95% CI
Abdomen
0.367
± 0.145
Upper Thigh
0.328
± 0.160
Back of the Upper Arm
0.337
± 0.180
Trough concentration at Month 4
Group
Value
95% CI
Abdomen
0.299
± 0.131
Upper Thigh
0.267
± 0.133
Back of the Upper Arm
0.248
± 0.105
Trough concentration at Month 8
Group
Value
95% CI
Abdomen
0.455
± 0.159
Upper Thigh
0.404
± 0.145
Back of the Upper Arm
0.305
± 0.125
Trough concentration at Month 12
Group
Value
95% CI
Abdomen
0.502
± 0.148
Upper Thigh
0.431
± 0.127
Back of the Upper Arm
0.362
± 0.155
Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product WithdrawalSecondary· 12 months after treatment initiation
The overall safety of study drug will be assessed throughout the study by evaluating the occurrence of SAEs and AEs leading to product discontinuation, blood pressure and weight at regularly scheduled visits, and changes in bleeding pattern.
Abdominal pain lower
Group
Value
95% CI
Abdomen
0
Upper Thigh
2
Back of Upper Arm
0
Injection site discolouration
Group
Value
95% CI
Abdomen
1
Upper Thigh
0
Back of Upper Arm
0
Injection site oedema
Group
Value
95% CI
Abdomen
0
Upper Thigh
1
Back of Upper Arm
0
Injection site reaction
Group
Value
95% CI
Abdomen
9
Upper Thigh
6
Back of Upper Arm
0
Lower limb fracture
Group
Value
95% CI
Abdomen
1
Upper Thigh
0
Back of Upper Arm
0
Weight decreased
Group
Value
95% CI
Abdomen
1
Upper Thigh
3
Back of Upper Arm
0
Weight increased
Group
Value
95% CI
Abdomen
2
Upper Thigh
0
Back of Upper Arm
1
Pain in extremity
Group
Value
95% CI
Abdomen
0
Upper Thigh
1
Back of Upper Arm
0
Acceptability of Sayana® PressSecondary· 12 months after treatment initiation
Perception of bleeding patterns and other responses to acceptability questions will be summarized using descriptive statistics based on routine questions asked at regularly scheduled visits (enrollment, months 4 and 8, and final). Acceptability data collected during unscheduled visits are not included in this table.
Group
Value
95% CI
Abdomen
306
Upper Thigh
313
Back of Upper Arm
34
Abdomen
22
Upper Thigh
23
Back of Upper Arm
4
Return to Ovulation After 12 Months of Use of Sayana Press When Injected Every Four Months.Secondary· A maximum of 12 months from the last study injection.
Return to ovulation among a subset of study participants who received month 4 and month 8 injections and plan to use non-hormonal methods of contraception, or no contraception for up to a maximum of 12 months from the last study injection. Ovulation is defined as a single elevated serum progesterone (P ≥4.7 ng/mL) or a confirmed pregnancy test.
Women who ovulated or became pregnant by 42 weeks after final injection
Group
Value
95% CI
Abdomen
25
3.2 – 65.1
Upper Thigh
18.2
2.3 – 51.8
Women who ovulated or became pregnant by 50 weeks after final injection
Group
Value
95% CI
Abdomen
50
15.7 – 84.3
Upper Thigh
54.5
23.4 – 83.3
Adverse events — posted to ClinicalTrials.gov
Time frame: 12 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07365904 — Investigating Ovulation Inhibition for Use as a Contraceptive
· Phase 2
· recruiting
NCT07437495 — Women's Knowledge of Contraception During the Postpartum Period
· active not recruiting
NCT06823037 — Hormonal Contraception Access Through Pharmacist Prescribing Implementation
· NA
· recruiting
NCT07326007 — Verbal Analgesia Versus Standard Technique for Pain Control During Copper T380A Intrauterine Device Insertion in Women W
· NA
· recruiting
NCT05910580 — Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years
· NA
· recruiting
Other FHI 360 trials
Trials by the same sponsor.
NCT05233956 — Levonorgestrel Intrauterine System Effects on Hemoglobin and Serum Ferritin Among Anemic Women in Kenya
· NA
· active not recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by FHI 360
Last refreshed: 30 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03154125.