Trial Outcomes & Findings for Post Marketing Surveillance Study For Sayana® (NCT NCT02104557)

NCT ID: NCT02104557

Last Updated: 2021-06-10

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 362 participants
• Primary outcome timeframe: Baseline up to a maximum of 12 months
• Results posted on: 2021-06-10

Participant Flow

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

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.

Participant milestones

Measure	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.
Overall Study STARTED	362
Overall Study Safety Population	337
Overall Study COMPLETED	185
Overall Study NOT COMPLETED	177

Reasons for withdrawal

Measure	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.
Overall Study Adverse Event	24
Overall Study Lost to Follow-up	34
Overall Study Violated the usage and dosage	14
Overall Study No longer met inclusion/exclusion criteria	1
Overall Study Administered Sayana prior to the contract	1
Overall Study Other	17
Overall Study Change to other contraception methods	5
Overall Study Discontinuation due to no pain	1
Overall Study Withdrawal consent	2
Overall Study Refusal of administration due to unknown reasons	69
Overall Study Discontinuation of contraception	9

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Sayana n=337 Participants 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.
Age, Continuous	34.92 years STANDARD_DEVIATION 8.62 • n=337 Participants
Sex: Female, Male Female	337 Participants n=337 Participants
Sex: Female, Male Male	0 Participants n=337 Participants

PRIMARY outcome

Timeframe: Baseline up to a maximum of 12 months

Population: Safety analysis set included all participants who received at least 1 dose of Sayana.

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.

Outcome measures

Measure	Sayana n=337 Participants 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.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	81 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	1 Participants

PRIMARY outcome

Timeframe: Baseline up to a maximum of 12 months

Population: Safety analysis set included all participants who received at least 1 dose of Sayana.

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.

Outcome measures

Measure	Sayana n=337 Participants 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.
Number of Participants Discontinued From Study Due to AEs	22 Participants

PRIMARY outcome

Timeframe: Baseline up to a maximum of 12 months

Population: Safety analysis set included all participants who received at least 1 dose of Sayana.

Number of participants taking any medications other than Sayana (concomitant medication) to treat AEs are reported.

Outcome measures

Measure	Sayana n=337 Participants 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.
Number of Participants Used Concomitant Medications for Treating AEs	54 Participants

PRIMARY outcome

Timeframe: Baseline up to a maximum of 12 months

Population: Safety analysis set included all participants who received at least 1 dose of Sayana.

Laboratory tests included hematology, biochemistry, and urinalysis. Clinical significance was identified by investigators' judgements based on laboratory test results.

Outcome measures

Measure	Sayana n=337 Participants 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.
Number of Participants With Clinically Significant Laboratory Test Abnormalities	0 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Sayana n=182 Participants 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.
Percentage of Participants Who Became Pregnant Over Observation Period	0 percentage of participants Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Sayana n=182 Participants 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.
Rate of Pregnancies Per 100 Participant-years of Follow-up	0 pregnancies per 100 participant-years Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Sayana n=144 Participants 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.
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
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 outcome

Timeframe: 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.

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.

Outcome measures

Measure	Sayana n=105 Participants 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.
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 outcome

Timeframe: 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.

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.

Outcome measures

Measure	Sayana n=10 Participants 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.
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 outcome

Timeframe: 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.

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.

Outcome measures

Measure	Sayana n=4 Participants 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.
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

Adverse Events

Sayana

Serious events: 1 serious events

Other events: 80 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sayana n=337 participants at risk 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.
Reproductive system and breast disorders Vaginal haemorrhage	0.30% 1/337 • 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.

Other adverse events

Measure	Sayana n=337 participants at risk 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.
General disorders Pelvic pain	0.30% 1/337 • 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.
Nervous system disorders Headache	0.30% 1/337 • 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.
Nervous system disorders Tremor	0.30% 1/337 • 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.
Metabolism and nutrition disorders Weight increase	0.89% 3/337 • 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.
Musculoskeletal and connective tissue disorders Skeletal pain	0.30% 1/337 • 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.
Reproductive system and breast disorders Amenorrhoea	3.9% 13/337 • 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.
Reproductive system and breast disorders Breast pain	0.30% 1/337 • 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.
Reproductive system and breast disorders Metrorrhagia	0.89% 3/337 • 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.
Reproductive system and breast disorders Vaginal haemorrhage	17.2% 58/337 • 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.
Immune system disorders Common cold	0.30% 1/337 • 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.
Skin and subcutaneous tissue disorders Alopecia	0.30% 1/337 • 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.
Skin and subcutaneous tissue disorders Pruritus	0.30% 1/337 • 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.
Cardiac disorders Flushing	0.30% 1/337 • 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.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

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