Product Surveillance, Postmarketing
Conditions
Keywords
Sayana, Pregnancy, Contraception, Endometriosis-associated pain, PMS, Post Marketing Surveillance
Brief summary
Post Marketing Surveillance To Observe Safety And Efficacy Of Sayana® Used For Contraception And Management Of Endometriosis-Associated Pain
Detailed description
Post Marketing Surveillance required by Korea MFDS regulation. Select among patients who randomly visit the site who meet the inclusion/exclusion criteria.
Interventions
OTHERNon intervention
Non intervention
Sponsors
Pfizer
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
0 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Subjects or legally authorized representatives of pediatric subjects agree to provide written informed consent form (ie, data privacy statement). 2.Women subjects who are initiating treatment with Sayana® for the first time as per the local product document for usage
Exclusion criteria
* Known or suspected pregnancy. * Undiagnosed vaginal bleeding. * Known or suspected malignancy of breast. * Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease. * Significant liver disease. * Known hypersensitivity to medroxyprogesterone acetate or any of its other ingredients. * Women who are before menarche or who are post-menopausal. * Treatment with any investigational agent or device within 30 days prior to the enrollment visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to a maximum of 12 months | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. AEs included both serious and all non-serious adverse events. |
| Number of Participants Discontinued From Study Due to AEs | Baseline up to a maximum of 12 months | Participants who discontinued permanently from the study due to AEs are reported. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. |
| Number of Participants Used Concomitant Medications for Treating AEs | Baseline up to a maximum of 12 months | Number of participants taking any medications other than Sayana (concomitant medication) to treat AEs are reported. |
| Number of Participants With Clinically Significant Laboratory Test Abnormalities | Baseline up to a maximum of 12 months | Laboratory tests included hematology, biochemistry, and urinalysis. Clinical significance was identified by investigators' judgements based on laboratory test results. |
| Percentage of Participants Who Became Pregnant Over Observation Period | Baseline up to 12 months | The cumulative percent of participants who became pregnant over observation period was calculated as 100\*(1- Kaplan-Meier curve at month 12), where the Kaplan-Meier (KM) method for estimating survival function was applied to time-to-pregnancy. |
| Rate of Pregnancies Per 100 Participant-years of Follow-up | Baseline up to 12 months | Pregnancies per 100 person-years of follow-up defined as major events, incidence rate was calculated as: 100\*(total number of participants with effectiveness endpoint)/(total person-years of participants included in the effectiveness analysis set) where total person-years is equal to (last evaluation date of outcome - first date of administration +1)/365.25 for all participants in the effective analysis set. |
| Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of First Dose (Month 3) of Study Drug | Baseline, Month 3 | Participants were asked to indicate the subjective level of endometriosis pain looking back at the last 3 months and mark it with a single vertical mark on the 100 millimeter (mm) horizontal visual analogue scale, where 0 mm represented absence of pain and 100 mm indicated unbearable pain. Higher score indicated more pain. Change from baseline in pain VAS score after administration of first dose of study drug is reported in this outcome measure. |
| Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Second Dose (Month 6) of Study Drug | Baseline, Month 6 | Participants were asked to indicate the subjective level of endometriosis pain looking back at the last 3 months and mark it with a single vertical mark on the 100 mm horizontal visual analogue scale, where 0 mm represented absence of pain and 100 mm indicated unbearable pain. Higher score indicated more pain. Change from baseline in pain VAS score after administration of second dose of study drug is reported in this outcome measure. |
| Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Third Dose (Month 9) of Study Drug | Baseline, Month 9 | Participants were asked to indicate the subjective level of endometriosis pain looking back at the last 3 months and mark it with a single vertical mark on the 100 mm horizontal visual analogue scale, where 0 mm represented absence of pain and 100 mm indicated unbearable pain. Higher score indicated more pain. Change from baseline in pain VAS score after administration of third dose of study drug is reported in this outcome measure. |
| Change From Baseline in in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Fourth Dose (Month 12) of Study Drug | Baseline, Month 12 | Participants were asked to indicate the subjective level of endometriosis pain looking back at the last 3 months and mark it with a single vertical mark on the 100 mm horizontal visual analogue scale, where 0 mm represented absence of pain and 100 mm indicated unbearable pain. Higher score indicated more pain. Change from baseline in pain VAS score after administration of fourth dose of study drug is reported in this outcome measure. |
Countries
South Korea
Participant flow
Recruitment details
Participants were planned to be observed for 6 months from enrolment date but few of them were followed beyond 6 months, up to a maximum of 12 months based on investigators' judgement
Pre-assignment details
Main objective of this study was to conduct safety analysis of Sayana injection in participants during usual care setting so data for both groups (pregnancy prevention group and endometriosis associated pain group) were combined and presented. For efficacy analysis data was collected separately for both groups.
Participants by arm
| Arm | Count |
|---|---|
| Sayana Participants were administered with Sayana (medroxyprogesterone acetate) as part of routine practice in Korean health care centers by accredited physicians per the local product document. | 337 |
| Total | 337 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administered Sayana prior to the contract | 1 |
| Overall Study | Adverse Event | 24 |
| Overall Study | Change to other contraception methods | 5 |
| Overall Study | Discontinuation due to no pain | 1 |
| Overall Study | Discontinuation of contraception | 9 |
| Overall Study | Lost to Follow-up | 34 |
| Overall Study | No longer met inclusion/exclusion criteria | 1 |
| Overall Study | Other | 17 |
| Overall Study | Refusal of administration due to unknown reasons | 69 |
| Overall Study | Violated the usage and dosage | 14 |
| Overall Study | Withdrawal consent | 2 |
Baseline characteristics
| Characteristic | Sayana | — |
|---|---|---|
| Age, Continuous | 34.92 years STANDARD_DEVIATION 8.62 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 337 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 337 |
| other Total, other adverse events | 80 / 337 |
| serious Total, serious adverse events | 1 / 337 |
Outcome results
Primary
Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of First Dose (Month 3) of Study Drug
Participants were asked to indicate the subjective level of endometriosis pain looking back at the last 3 months and mark it with a single vertical mark on the 100 millimeter (mm) horizontal visual analogue scale, where 0 mm represented absence of pain and 100 mm indicated unbearable pain. Higher score indicated more pain. Change from baseline in pain VAS score after administration of first dose of study drug is reported in this outcome measure.
Time frame: Baseline, Month 3
Population: Efficacy analysis set included all participants who received at least 1 dose of Sayana and evaluated for efficacy at least once. Here, Overall number of participants analyzed = participants who were administered with Sayana for the management of endometriosis-associated pain at Month 3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sayana | Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of First Dose (Month 3) of Study Drug | Baseline | 48.32 millimeter | Standard Deviation 31.9 |
| Sayana | Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of First Dose (Month 3) of Study Drug | Change at Month 3 | -29.63 millimeter | Standard Deviation 29.31 |
Primary
Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Second Dose (Month 6) of Study Drug
Participants were asked to indicate the subjective level of endometriosis pain looking back at the last 3 months and mark it with a single vertical mark on the 100 mm horizontal visual analogue scale, where 0 mm represented absence of pain and 100 mm indicated unbearable pain. Higher score indicated more pain. Change from baseline in pain VAS score after administration of second dose of study drug is reported in this outcome measure.
Time frame: Baseline, Month 6
Population: Efficacy analysis set included all participants who received at least 1 dose of Sayana and evaluated for efficacy at least once. Here, Overall number of participants analyzed = participants who were administered with Sayana for the management of endometriosis-associated pain at Month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sayana | Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Second Dose (Month 6) of Study Drug | -33.02 millimeter | Standard Deviation 30.8 |
Primary
Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Third Dose (Month 9) of Study Drug
Participants were asked to indicate the subjective level of endometriosis pain looking back at the last 3 months and mark it with a single vertical mark on the 100 mm horizontal visual analogue scale, where 0 mm represented absence of pain and 100 mm indicated unbearable pain. Higher score indicated more pain. Change from baseline in pain VAS score after administration of third dose of study drug is reported in this outcome measure.
Time frame: Baseline, Month 9
Population: Efficacy analysis set included all participants who received at least 1 dose of Sayana and evaluated for efficacy at least once. Here, Overall number of participants analyzed =participants who were administered with Sayana for the management of endometriosis-associated pain at Month 9.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sayana | Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Third Dose (Month 9) of Study Drug | -37.8 millimeter | Standard Deviation 30.7 |
Primary
Change From Baseline in in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Fourth Dose (Month 12) of Study Drug
Participants were asked to indicate the subjective level of endometriosis pain looking back at the last 3 months and mark it with a single vertical mark on the 100 mm horizontal visual analogue scale, where 0 mm represented absence of pain and 100 mm indicated unbearable pain. Higher score indicated more pain. Change from baseline in pain VAS score after administration of fourth dose of study drug is reported in this outcome measure.
Time frame: Baseline, Month 12
Population: Efficacy analysis set included all participants who received at least 1 dose of Sayana and evaluated for efficacy at least once. Here, Overall number of participants analyzed = participants who were administered with Sayana for the management of endometriosis-associated pain at Month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sayana | Change From Baseline in in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Fourth Dose (Month 12) of Study Drug | -49.25 millimeter | Standard Deviation 29.98 |
Primary
Number of Participants Discontinued From Study Due to AEs
Participants who discontinued permanently from the study due to AEs are reported. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.
Time frame: Baseline up to a maximum of 12 months
Population: Safety analysis set included all participants who received at least 1 dose of Sayana.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sayana | Number of Participants Discontinued From Study Due to AEs | 22 Participants |
Primary
Number of Participants Used Concomitant Medications for Treating AEs
Number of participants taking any medications other than Sayana (concomitant medication) to treat AEs are reported.
Time frame: Baseline up to a maximum of 12 months
Population: Safety analysis set included all participants who received at least 1 dose of Sayana.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sayana | Number of Participants Used Concomitant Medications for Treating AEs | 54 Participants |
Primary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. AEs included both serious and all non-serious adverse events.
Time frame: Baseline up to a maximum of 12 months
Population: Safety analysis set included all participants who received at least 1 dose of Sayana.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sayana | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 81 Participants |
| Sayana | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 1 Participants |
Primary
Number of Participants With Clinically Significant Laboratory Test Abnormalities
Laboratory tests included hematology, biochemistry, and urinalysis. Clinical significance was identified by investigators' judgements based on laboratory test results.
Time frame: Baseline up to a maximum of 12 months
Population: Safety analysis set included all participants who received at least 1 dose of Sayana.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sayana | Number of Participants With Clinically Significant Laboratory Test Abnormalities | 0 Participants |
Primary
Percentage of Participants Who Became Pregnant Over Observation Period
The cumulative percent of participants who became pregnant over observation period was calculated as 100\*(1- Kaplan-Meier curve at month 12), where the Kaplan-Meier (KM) method for estimating survival function was applied to time-to-pregnancy.
Time frame: Baseline up to 12 months
Population: Efficacy analysis set included all participants who received at least 1 dose of Sayana and evaluated for efficacy at least once. Here, Overall number of participants analyzed = participants who were administered with Sayana for pregnancy prevention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sayana | Percentage of Participants Who Became Pregnant Over Observation Period | 0 percentage of participants |
Primary
Rate of Pregnancies Per 100 Participant-years of Follow-up
Pregnancies per 100 person-years of follow-up defined as major events, incidence rate was calculated as: 100\*(total number of participants with effectiveness endpoint)/(total person-years of participants included in the effectiveness analysis set) where total person-years is equal to (last evaluation date of outcome - first date of administration +1)/365.25 for all participants in the effective analysis set.
Time frame: Baseline up to 12 months
Population: Efficacy analysis set included all participants who received at least 1 dose of Sayana and evaluated for efficacy at least once. Here, Overall number of participants analyzed = participants who were administered with Sayana for pregnancy prevention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sayana | Rate of Pregnancies Per 100 Participant-years of Follow-up | 0 pregnancies per 100 participant-years |