Trial Outcomes & Findings for Sayana® Press Extension Study (NCT NCT03154125)
NCT ID: NCT03154125
Last Updated: 2024-08-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
750 participants
Primary outcome timeframe
12 months after treatment initiation
Results posted on
2024-08-30
Participant Flow
836 Screened, 86 Not Enrolled - Medically Ineligible: 26, Declined to Enroll: 24, Ineligible due to Sexual Behavior or Recent Contraceptive Use: 19, Unable to Comply with Study Req.:15, Investigator Discretion: 2
Participant milestones
| Measure |
Abdomen
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).
Sayana® Press: 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.
|
Upper Thigh
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).
Sayana® Press: 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.
|
Back of the Upper Arm
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).
Sayana® Press: 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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
355
|
355
|
40
|
|
Overall Study
Randomized to PK Cohort
|
40
|
40
|
40
|
|
Overall Study
PK Population
|
35
|
33
|
32
|
|
Overall Study
Excluded From PK Population
|
5
|
7
|
8
|
|
Overall Study
COMPLETED
|
279
|
278
|
32
|
|
Overall Study
NOT COMPLETED
|
76
|
77
|
8
|
Reasons for withdrawal
| Measure |
Abdomen
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).
Sayana® Press: 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.
|
Upper Thigh
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).
Sayana® Press: 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.
|
Back of the Upper Arm
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).
Sayana® Press: 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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
11
|
0
|
|
Overall Study
Withdrawal by Subject
|
49
|
55
|
8
|
|
Overall Study
Physician Decision
|
13
|
6
|
0
|
|
Overall Study
Protocol Violation
|
3
|
5
|
0
|
Baseline Characteristics
Sayana® Press Extension Study
Baseline characteristics by cohort
| Measure |
Abdomen
n=355 Participants
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).
Sayana® Press: 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.
|
Upper Thigh
n=355 Participants
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).
Sayana® Press: 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.
|
Back of the Upper Arm
n=40 Participants
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).
Sayana® Press: 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.
|
Total
n=750 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
participants18-29 years
|
266 Participants
n=5 Participants
|
273 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
570 Participants
n=4 Participants
|
|
Age, Customized
participants 30-40 years
|
89 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
180 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Female
|
355 participants
n=5 Participants
|
355 participants
n=7 Participants
|
40 participants
n=5 Participants
|
750 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
104 participants
n=5 Participants
|
104 participants
n=7 Participants
|
20 participants
n=5 Participants
|
228 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
28 participants
n=5 Participants
|
29 participants
n=7 Participants
|
1 participants
n=5 Participants
|
58 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Bi-/Multi-racial
|
223 participants
n=5 Participants
|
222 participants
n=7 Participants
|
19 participants
n=5 Participants
|
464 participants
n=4 Participants
|
|
Education
Participants ≤9 years
|
94 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
192 Participants
n=4 Participants
|
|
Education
Participants >9 years
|
261 Participants
n=5 Participants
|
264 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
558 Participants
n=4 Participants
|
|
Average times have vaginal sex per month with male partner
|
12.1 Events per month
STANDARD_DEVIATION 7.27 • n=5 Participants
|
11.9 Events per month
STANDARD_DEVIATION 8.09 • n=7 Participants
|
10.2 Events per month
STANDARD_DEVIATION 6.23 • n=5 Participants
|
11.9 Events per month
STANDARD_DEVIATION 7.62 • n=4 Participants
|
|
Weight
|
72.7 kg
STANDARD_DEVIATION 18.72 • n=5 Participants
|
71.1 kg
STANDARD_DEVIATION 16.89 • n=7 Participants
|
72.1 kg
STANDARD_DEVIATION 15.21 • n=5 Participants
|
71.9 kg
STANDARD_DEVIATION 17.70 • n=4 Participants
|
|
Height
|
160.7 cm
STANDARD_DEVIATION 5.98 • n=5 Participants
|
160.5 cm
STANDARD_DEVIATION 6.70 • n=7 Participants
|
160.6 cm
STANDARD_DEVIATION 6.38 • n=5 Participants
|
160.6 cm
STANDARD_DEVIATION 6.34 • n=4 Participants
|
PRIMARY outcome
Timeframe: 12 months after treatment initiationPopulation: The primary study objective is to evaluate the effectiveness of Sayana® Press when injected subcutaneously every 4 months among women in the Treated Analysis set who received injections in the abdomen or upper thigh. This outcome measure was pre-specified to only assess participants who were injected in the abdomen and upper thigh.
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.
Outcome measures
| Measure |
Abdomen
n=355 Participants
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).
Sayana® Press: 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.
|
Upper Thigh
n=355 Participants
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).
Sayana® Press: 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.
|
Back of the Upper Arm
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).
Sayana® Press: 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.
|
|---|---|---|---|
|
Occurrence of Pregnancy
|
0 Pregnancies per 100 women years
Interval 0.0 to 1.18
|
0 Pregnancies per 100 women years
Interval 0.0 to 1.17
|
—
|
SECONDARY outcome
Timeframe: 2, 3, 4, 8, and 12 months after treatment initiationPopulation: Subset of study participants consenting to MPA concentration analysis. Excluding participants who did not contribute blood specimens, who had baseline MPA \>0.05 ng/mL, or who required the use of more than 1 Sayana Press unit or their baseline injection. Also, the analysis set excludes any MPA specimens collected during a time when a participant reports using a concomitant medication that may impact the PK of MPA. The analysis set excludes any MPA results after an injection with more than 1 unit.
Pharmacokinetic endpoints include serum MPA concentrations at month 2, 3, 4, 8, and 12.
Outcome measures
| Measure |
Abdomen
n=35 Participants
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).
Sayana® Press: 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.
|
Upper Thigh
n=33 Participants
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).
Sayana® Press: 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.
|
Back of the Upper Arm
n=32 Participants
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).
Sayana® Press: 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.
|
|---|---|---|---|
|
Serum MPA Concentrations in a Subset of 120 Participants
Trough concentration at Month 2
|
0.503 ng/mL
Standard Deviation 0.263
|
0.355 ng/mL
Standard Deviation 0.155
|
0.490 ng/mL
Standard Deviation 0.264
|
|
Serum MPA Concentrations in a Subset of 120 Participants
Trough concentration at Month 3
|
0.367 ng/mL
Standard Deviation 0.145
|
0.328 ng/mL
Standard Deviation 0.160
|
0.337 ng/mL
Standard Deviation 0.180
|
|
Serum MPA Concentrations in a Subset of 120 Participants
Trough concentration at Month 4
|
0.299 ng/mL
Standard Deviation 0.131
|
0.267 ng/mL
Standard Deviation 0.133
|
0.248 ng/mL
Standard Deviation 0.105
|
|
Serum MPA Concentrations in a Subset of 120 Participants
Trough concentration at Month 8
|
0.455 ng/mL
Standard Deviation 0.159
|
0.404 ng/mL
Standard Deviation 0.145
|
0.305 ng/mL
Standard Deviation 0.125
|
|
Serum MPA Concentrations in a Subset of 120 Participants
Trough concentration at Month 12
|
0.502 ng/mL
Standard Deviation 0.148
|
0.431 ng/mL
Standard Deviation 0.127
|
0.362 ng/mL
Standard Deviation 0.155
|
SECONDARY outcome
Timeframe: 12 months after treatment initiationPopulation: Whole study population
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.
Outcome measures
| Measure |
Abdomen
n=34 Events
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).
Sayana® Press: 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.
|
Upper Thigh
n=38 Events
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).
Sayana® Press: 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.
|
Back of the Upper Arm
n=5 Events
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).
Sayana® Press: 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.
|
|---|---|---|---|
|
Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal
Abdominal pain lower
|
0 Events
|
2 Events
|
0 Events
|
|
Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal
Injection site discolouration
|
1 Events
|
0 Events
|
0 Events
|
|
Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal
Injection site oedema
|
0 Events
|
1 Events
|
0 Events
|
|
Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal
Injection site reaction
|
9 Events
|
6 Events
|
0 Events
|
|
Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal
Lower limb fracture
|
1 Events
|
0 Events
|
0 Events
|
|
Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal
Weight decreased
|
1 Events
|
3 Events
|
0 Events
|
|
Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal
Weight increased
|
2 Events
|
0 Events
|
1 Events
|
|
Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal
Pain in extremity
|
0 Events
|
1 Events
|
0 Events
|
|
Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal
Cerebrovascular accident
|
1 Events
|
0 Events
|
0 Events
|
|
Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal
Headache
|
1 Events
|
1 Events
|
0 Events
|
|
Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal
Libido decreased
|
2 Events
|
0 Events
|
0 Events
|
|
Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal
Mood altered
|
1 Events
|
0 Events
|
0 Events
|
|
Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal
Amenorrhoea
|
2 Events
|
5 Events
|
0 Events
|
|
Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal
Menometrorrhagia
|
0 Events
|
1 Events
|
0 Events
|
|
Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal
Menstruation irregular
|
9 Events
|
14 Events
|
4 Events
|
|
Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal
Metrorrhagia
|
0 Events
|
2 Events
|
0 Events
|
|
Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal
Oligomenorrhoea
|
1 Events
|
1 Events
|
0 Events
|
|
Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal
Pelvic pain
|
1 Events
|
0 Events
|
0 Events
|
|
Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal
Vulvovaginal dryness
|
0 Events
|
1 Events
|
0 Events
|
|
Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal
Acne
|
2 Events
|
0 Events
|
0 Events
|
SECONDARY outcome
Timeframe: 12 months after treatment initiationPopulation: Treated Population: Safety Analysis Set.
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.
Outcome measures
| Measure |
Abdomen
n=328 Participants
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).
Sayana® Press: 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.
|
Upper Thigh
n=336 Participants
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).
Sayana® Press: 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.
|
Back of the Upper Arm
n=38 Participants
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).
Sayana® Press: 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.
|
|---|---|---|---|
|
Acceptability of Sayana® Press
Would you like to use Sayana Press as a 4-month method in the future if proven effective? : Yes
|
306 Participants
|
313 Participants
|
34 Participants
|
|
Acceptability of Sayana® Press
Would you like to use Sayana Press as a 4-month method in the future if proven effective? : No
|
22 Participants
|
23 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: A maximum of 12 months from the last study injection.Population: A subset of \~20 participants at study sites in Brazil and Dominican Republic who received month 4 and month 8 injections and planned to use a non-hormonal contraceptive method, or no contraception, after study discontinuation. One participant who received an injection in the abdomen discontinued early and was censored from analysis at 41 weeks past final injection. The subset was restricted to participants included in the primary analysis, those injected in the abdomen or thigh.
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.
Outcome measures
| Measure |
Abdomen
n=8 Participants
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).
Sayana® Press: 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.
|
Upper Thigh
n=11 Participants
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).
Sayana® Press: 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.
|
Back of the Upper Arm
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).
Sayana® Press: 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.
|
|---|---|---|---|
|
Return to Ovulation After 12 Months of Use of Sayana Press When Injected Every Four Months.
Women who ovulated or became pregnant by 42 weeks after final injection
|
25 Percentage of participants
Interval 3.2 to 65.1
|
18.2 Percentage of participants
Interval 2.3 to 51.8
|
—
|
|
Return to Ovulation After 12 Months of Use of Sayana Press When Injected Every Four Months.
Women who ovulated or became pregnant by 50 weeks after final injection
|
50 Percentage of participants
Interval 15.7 to 84.3
|
54.5 Percentage of participants
Interval 23.4 to 83.3
|
—
|
Adverse Events
Abdomen
Serious events: 2 serious events
Other events: 32 other events
Deaths: 0 deaths
Upper Thigh
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Back of the Upper Arm
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Abdomen
n=355 participants at risk
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).
Sayana® Press: 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.
|
Upper Thigh
n=355 participants at risk
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).
Sayana® Press: 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.
|
Back of the Upper Arm
n=40 participants at risk
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).
Sayana® Press: 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.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.28%
1/355 • 12 months
|
0.00%
0/355 • 12 months
|
0.00%
0/40 • 12 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.28%
1/355 • 12 months
|
0.00%
0/355 • 12 months
|
0.00%
0/40 • 12 months
|
Other adverse events
| Measure |
Abdomen
n=355 participants at risk
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).
Sayana® Press: 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.
|
Upper Thigh
n=355 participants at risk
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).
Sayana® Press: 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.
|
Back of the Upper Arm
n=40 participants at risk
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).
Sayana® Press: 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.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/355 • 12 months
|
0.56%
2/355 • 12 months
|
0.00%
0/40 • 12 months
|
|
General disorders
Injection Site Discolouration
|
0.28%
1/355 • 12 months
|
0.00%
0/355 • 12 months
|
0.00%
0/40 • 12 months
|
|
General disorders
Injection Site Oedema
|
0.00%
0/355 • 12 months
|
0.28%
1/355 • 12 months
|
0.00%
0/40 • 12 months
|
|
General disorders
Injection Site Reaction
|
2.5%
9/355 • 12 months
|
1.7%
6/355 • 12 months
|
0.00%
0/40 • 12 months
|
|
Investigations
Weight Decreased
|
0.28%
1/355 • 12 months
|
0.85%
3/355 • 12 months
|
0.00%
0/40 • 12 months
|
|
Investigations
Weight Increased
|
0.56%
2/355 • 12 months
|
0.00%
0/355 • 12 months
|
2.5%
1/40 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/355 • 12 months
|
0.28%
1/355 • 12 months
|
0.00%
0/40 • 12 months
|
|
Nervous system disorders
Headache
|
0.28%
1/355 • 12 months
|
0.28%
1/355 • 12 months
|
0.00%
0/40 • 12 months
|
|
Psychiatric disorders
Libido Decreased
|
0.56%
2/355 • 12 months
|
0.00%
0/355 • 12 months
|
0.00%
0/40 • 12 months
|
|
Psychiatric disorders
Mood Altered
|
0.28%
1/355 • 12 months
|
0.00%
0/355 • 12 months
|
0.00%
0/40 • 12 months
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.56%
2/355 • 12 months
|
1.4%
5/355 • 12 months
|
0.00%
0/40 • 12 months
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.00%
0/355 • 12 months
|
0.28%
1/355 • 12 months
|
0.00%
0/40 • 12 months
|
|
Reproductive system and breast disorders
Menstruation Irregular
|
2.5%
9/355 • 12 months
|
3.9%
14/355 • 12 months
|
10.0%
4/40 • 12 months
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/355 • 12 months
|
0.56%
2/355 • 12 months
|
0.00%
0/40 • 12 months
|
|
Reproductive system and breast disorders
Oligomenorrhoea
|
0.28%
1/355 • 12 months
|
0.28%
1/355 • 12 months
|
0.00%
0/40 • 12 months
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.28%
1/355 • 12 months
|
0.00%
0/355 • 12 months
|
0.00%
0/40 • 12 months
|
|
Reproductive system and breast disorders
Vulvovaginal Dryness
|
0.00%
0/355 • 12 months
|
0.28%
1/355 • 12 months
|
0.00%
0/40 • 12 months
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.56%
2/355 • 12 months
|
0.00%
0/355 • 12 months
|
0.00%
0/40 • 12 months
|
Additional Information
Vera Halpern, M.D., Director of Clinical Development
FHI 360
Phone: +1 (919) 321-3331
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place