Trial Outcomes & Findings for Sayana Press UK Self-Injection Study (NCT NCT03034057)
NCT ID: NCT03034057
Last Updated: 2019-10-18
Results Overview
Each participant had a maximum of 3 home self-injections, each of which was defined as a success or failure. A success was defined as a home self-injection that was successfully performed by the participant at home and on schedule (13 week interval +/- 1 week) where all attempts were included in the denominator. If the participant attempted but was unable to administer the self-injection at home and had it performed instead at the clinic, then these were classed as failures. This outcome measure was analyzed by generalized estimating equation (GEE) model using participant as the clustering variable. The GEE model used the logit link and contained an intercept term. The 95% confidence interval (CI) for the intercept was transformed to a 95% CI for the self-injection success rate.
COMPLETED
PHASE4
169 participants
Up to 1 year
2019-10-18
Participant Flow
A total of 169 adult women participants of reproductive age (18 to 45 years) were enrolled in the study.
Participant milestones
| Measure |
Sayana Press
Following product use education and a supervised initial self-injection at the baseline visit, participants self-injected Sayana Press in the home setting every 3 months (at Month 3, Month 6 and Month 9) and returned for a final study visit at Month 12.
|
|---|---|
|
Overall Study
STARTED
|
169
|
|
Overall Study
COMPLETED
|
114
|
|
Overall Study
NOT COMPLETED
|
55
|
Reasons for withdrawal
| Measure |
Sayana Press
Following product use education and a supervised initial self-injection at the baseline visit, participants self-injected Sayana Press in the home setting every 3 months (at Month 3, Month 6 and Month 9) and returned for a final study visit at Month 12.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Not defined
|
2
|
|
Overall Study
Lost to Follow-up
|
19
|
|
Overall Study
Adverse Event
|
22
|
|
Overall Study
Medication error without associated AE
|
1
|
Baseline Characteristics
Sayana Press UK Self-Injection Study
Baseline characteristics by cohort
| Measure |
Sayana Press
n=169 Participants
Following product use education and a supervised initial self-injection at the baseline visit, participants self-injected Sayana Press in the home setting every 3 months (at Month 3, Month 6 and Month 9) and returned for a final study visit at Month 12.
|
|---|---|
|
Age, Continuous
|
29.1 Years
STANDARD_DEVIATION 7.26 • n=39 Participants
|
|
Sex: Female, Male
Female
|
169 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
154 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
163 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: The analysis population included participants who enrolled into the study.
Each participant had a maximum of 3 home self-injections, each of which was defined as a success or failure. A success was defined as a home self-injection that was successfully performed by the participant at home and on schedule (13 week interval +/- 1 week) where all attempts were included in the denominator. If the participant attempted but was unable to administer the self-injection at home and had it performed instead at the clinic, then these were classed as failures. This outcome measure was analyzed by generalized estimating equation (GEE) model using participant as the clustering variable. The GEE model used the logit link and contained an intercept term. The 95% confidence interval (CI) for the intercept was transformed to a 95% CI for the self-injection success rate.
Outcome measures
| Measure |
Sayana Press
n=169 Participants
Following product use education and a supervised initial self-injection at the baseline visit, participants self-injected Sayana Press in the home setting every 3 months (at Month 3, Month 6 and Month 9) and returned for a final study visit at Month 12.
|
|---|---|
|
Percentage of Successful Self-Injections Performed of All Attempts at Home on Schedule (Full Analysis Set)
|
88.8 Percentage of all attempts at home
Interval 85.1 to 91.6
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: The analysis population included participants who enrolled into the study. Participants at sites which required closure during study due to GCP violations were excluded from the analysis population.
Each participant had a maximum of 3 home self-injections, each of which was defined as a success or failure. A success was defined as a home self-injection that was successfully performed by the participant at home and on schedule (13 week interval +/- 1 week) where all attempts were included in the denominator. If the participant attempted but was unable to administer the self-injection at home and had it performed instead at the clinic, then these were classed as failures. This outcome measure was analyzed by GEE model using participant as the clustering variable. The GEE model used the logit link and contained an intercept term. The 95% CI for the intercept was transformed to a 95% CI for the self-injection success rate. The sensitivity analysis was conducted to eliminate the data from the discontinued site due to ongoing Good Clinical Practice (GCP) violations.
Outcome measures
| Measure |
Sayana Press
n=164 Participants
Following product use education and a supervised initial self-injection at the baseline visit, participants self-injected Sayana Press in the home setting every 3 months (at Month 3, Month 6 and Month 9) and returned for a final study visit at Month 12.
|
|---|---|
|
Percentage of Successful Self-Injections Performed of All Attempts at Home on Schedule (Sensitivity Analysis)
|
89.3 Percentage of all attempts at home
Interval 85.6 to 92.1
|
SECONDARY outcome
Timeframe: 1 yearPopulation: The analysis population included participants who enrolled into the study.
Continuation rate for the method at 1 year equals: (\[the number of participants who received all 4 injections and had not discontinued by 12 months\] / \[total number of participants in the study\]) \*100%. A 95% CI was calculated along with the continuation rate using normal approximation to the binominal.
Outcome measures
| Measure |
Sayana Press
n=169 Participants
Following product use education and a supervised initial self-injection at the baseline visit, participants self-injected Sayana Press in the home setting every 3 months (at Month 3, Month 6 and Month 9) and returned for a final study visit at Month 12.
|
|---|---|
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Continuation Rate for the Method (Self-injection With Sayana Press) at 1 Year
|
67.5 Percentage of total participants
Interval 59.8 to 74.5
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Adverse Events
Sayana Press
Serious adverse events
| Measure |
Sayana Press
n=169 participants at risk
Following product use education and a supervised initial self-injection at the baseline visit, participants self-injected Sayana Press in the home setting every 3 months (at Month 3, Month 6 and Month 9) and returned for a final study visit at Month 12.
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|---|---|
|
Gastrointestinal disorders
Food poisoning
|
0.59%
1/169 • Number of events 1 • Up to 1 year
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Mastitis
|
0.59%
1/169 • Number of events 1 • Up to 1 year
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.59%
1/169 • Number of events 1 • Up to 1 year
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.59%
1/169 • Number of events 1 • Up to 1 year
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.59%
1/169 • Number of events 1 • Up to 1 year
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
Other adverse events
| Measure |
Sayana Press
n=169 participants at risk
Following product use education and a supervised initial self-injection at the baseline visit, participants self-injected Sayana Press in the home setting every 3 months (at Month 3, Month 6 and Month 9) and returned for a final study visit at Month 12.
|
|---|---|
|
General disorders
Injection site bruising
|
13.0%
22/169 • Number of events 25 • Up to 1 year
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Injection site mass
|
5.3%
9/169 • Number of events 9 • Up to 1 year
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Injection site pain
|
6.5%
11/169 • Number of events 12 • Up to 1 year
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Psychiatric disorders
Depression
|
7.7%
13/169 • Number of events 13 • Up to 1 year
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
12.4%
21/169 • Number of events 21 • Up to 1 year
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER