Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Post Marketing Surveillance To Observe Safety And Efficacy Of Sayana® Used For Contraception And Management Of Endometriosis-Associated Pain
Post Marketing Surveillance required by Korea MFDS regulation. Select among patients who randomly visit the site who meet the inclusion/exclusion criteria.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prevention of pregnancy | Non intervention |
| |
| management of endometriosis-associated pain | Non intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non intervention | Other | Non intervention |
| |
| Non intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to a maximum of 12 months |
| 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. | Baseline up to a maximum of 12 months |
| 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. | Baseline up to a maximum of 12 months |
| 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. | Baseline up to a maximum of 12 months |
| 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. |
Not provided
Not provided
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:
Not provided
Not provided
Women subjects who are initiating treatment with Sayana® for the first time as per the local product document for usage
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Haeundae Paik Hospital | Haeundae-gu | Busan | 48108 | South Korea | ||
| Bundang Cha Medical Center |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Not provided
Not provided
Not provided
Not provided
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 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
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 21, 2018 | May 14, 2021 |
Not provided
Not provided
Not provided
Not provided
| Other |
Non intervention |
|
| Baseline up to 12 months |
| 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. | Baseline up to 12 months |
| 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. | Baseline, Month 3 |
| 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. | Baseline, Month 6 |
| 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. | Baseline, Month 9 |
| 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. | Baseline, Month 12 |
| Seongnam-si |
| Gyeonggi-do |
| 13496 |
| South Korea |
| CHA Bundang Medical Center-CHA University | Seongnam-si | Gyeonggi-do | 13496 | South Korea |
| Ajou University Hospital | Suwon | Gyeonggi-do | 16499 | South Korea |
| Soon Chun Hyang University Hospital Seoul | Seoul | Korea | 04401 | South Korea |
| Ulsan University Hospital | Ulsan | Korea | 44033 | South Korea |
| Min Hyunju Women's Clinic | Busan | South Korea |
| Keimyung University Dongsan Hospital | Daegu | 41931 | South Korea |
| Inje University Sanggye Paik Hospital | Seoul | 01757 | South Korea |
| Konkuk University Medical Center | Seoul | 05030 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Chung-Ang University Hospital | Seoul | 06973 | South Korea |
| Ewha Womans University Mokdong Hospital | Seoul | 07985 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 120-752 | South Korea |
| CHA Gangnam Medical Center, CHA University | Seoul | 135-913 | South Korea |
| Roen Clinic | Seoul | 135-932 | South Korea |
| Nana Clinic | Seoul | 137-809 | South Korea |
| Avenue Clinic | Seoul | 139-832 | South Korea |
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety analysis set included all participants who received at least 1 dose of Sayana.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety analysis set included all participants who received at least 1 dose of Sayana. | Posted | Count of Participants | Participants | Baseline up to a maximum of 12 months |
|
|
| |||||||||||||||||||||||||||||||||
| 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. | Safety analysis set included all participants who received at least 1 dose of Sayana. | Posted | Count of Participants | Participants | Baseline up to a maximum of 12 months |
|
| ||||||||||||||||||||||||||||||||||
| 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. | Safety analysis set included all participants who received at least 1 dose of Sayana. | Posted | Count of Participants | Participants | Baseline up to a maximum of 12 months |
|
| ||||||||||||||||||||||||||||||||||
| 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. | Safety analysis set included all participants who received at least 1 dose of Sayana. | Posted | Count of Participants | Participants | Baseline up to a maximum of 12 months |
|
| ||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 12 months |
|
| |||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | 95% Confidence Interval | pregnancies per 100 participant-years | Baseline up to 12 months |
|
| |||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | millimeter | Baseline, Month 3 |
|
| |||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | millimeter | Baseline, Month 6 |
|
| |||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | millimeter | Baseline, Month 9 |
|
| |||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | millimeter | Baseline, Month 12 |
|
|
Baseline up to a maximum of 12 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 337 | 1 | 337 | 80 | 337 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vaginal haemorrhage | Reproductive system and breast disorders | WHO-ART, Version 092 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pelvic pain | General disorders | WHO-ART, Version 092 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | WHO-ART, Version 092 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | WHO-ART, Version 092 | Non-systematic Assessment |
| |
| Weight increase | Metabolism and nutrition disorders | WHO-ART, Version 092 | Non-systematic Assessment |
| |
| Skeletal pain | Musculoskeletal and connective tissue disorders | WHO-ART, Version 092 | Non-systematic Assessment |
| |
| Amenorrhoea | Reproductive system and breast disorders | WHO-ART, Version 092 | Non-systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | WHO-ART, Version 092 | Non-systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | WHO-ART, Version 092 | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | WHO-ART, Version 092 | Non-systematic Assessment |
| |
| Common cold | Immune system disorders | WHO-ART, Version 092 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | WHO-ART, Version 092 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | WHO-ART, Version 092 | Non-systematic Assessment |
| |
| Flushing | Cardiac disorders | WHO-ART, Version 092 | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 27, 2020 | May 14, 2021 | SAP_001.pdf |
|
|
|
|
|
|
|
|
|