SAYANA: Post Marketing Surveillance Study For Sayana®

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02104557
• Collaborator: (none)
• Enrollment: 362
• Locations: 19
• Actual Duration (Months): 75.7
• Patients Per Site: 19.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Post Marketing Surveillance To Observe Safety And Efficacy Of Sayana® Used For Contraception And Management Of Endometriosis-Associated Pain

Condition or Disease	Intervention/Treatment	Phase
Product Surveillance, Postmarketing	Other: Non intervention; Other: Non intervention

Detailed Description

Post Marketing Surveillance required by Korea MFDS regulation. Select among patients who randomly visit the site who meet the inclusion/exclusion criteria.

Study Design

• Study Type: Observational
• Actual Enrollment: 362 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: POST MARKETING SURVEILLANCE TO OBSERVE SAFETY AND EFFICACY OF SAYANA(REGISTERED) USED FOR CONTRACEPTION AND MANAGEMENT OF ENDOMETRIOSIS-ASSOCIATED PAIN
• Actual Study Start Date: Feb 13, 2014
• Actual Primary Completion Date: Jun 5, 2020
• Actual Study Completion Date: Jun 5, 2020

Arms and Interventions

Arm	Intervention/Treatment
prevention of pregnancy Non intervention	Other: Non intervention; Non intervention
management of endometriosis-associated pain Non intervention	Other: Non intervention; Non intervention

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Inje University Haeundae Paik Hospital	Haeundae-gu	Busan	Korea, Republic of	48108
2	Bundang Cha Medical Center	Seongnam-si	Gyeonggi-do	Korea, Republic of	13496
3	CHA Bundang Medical Center-CHA University	Seongnam-si	Gyeonggi-do	Korea, Republic of	13496
4	Ajou University Hospital	Suwon-si	Gyeonggi-do	Korea, Republic of	16499
5	Soon Chun Hyang University Hospital Seoul	Seoul	Korea	Korea, Republic of	04401
6	Ulsan University Hospital	Ulsan	Korea	Korea, Republic of	44033
7	Min Hyunju Women's Clinic	Busan		Korea, Republic of
8	Keimyung University Dongsan Hospital	Daegu		Korea, Republic of	41931
9	Inje University Sanggye Paik Hospital	Seoul		Korea, Republic of	01757
10	Konkuk University Medical Center	Seoul		Korea, Republic of	05030
11	Asan Medical Center	Seoul		Korea, Republic of	05505
12	Samsung Medical Center	Seoul		Korea, Republic of	06351
13	Chung-Ang University Hospital	Seoul		Korea, Republic of	06973
14	Ewha Womans University Mokdong Hospital	Seoul		Korea, Republic of	07985
15	Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of	120-752
16	CHA Gangnam Medical Center, CHA University	Seoul		Korea, Republic of	135-913
17	Roen Clinic	Seoul		Korea, Republic of	135-932
18	Nana Clinic	Seoul		Korea, Republic of	137-809
19	Avenue Clinic	Seoul		Korea, Republic of	139-832

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

• Study Protocol - Mar 21, 2018
• Statistical Analysis Plan - Apr 27, 2020

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02104557
• Other Study ID Numbers: A6791036
• First Posted: Apr 4, 2014
• Last Update Posted: Jun 10, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Pfizer: Sayana; Pregnancy; Contraception; Endometriosis-associated pain; PMS; Post Marketing Surveillance
• Additional relevant MeSH terms: Endometriosis

Study Results

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 Detail	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.

Arm/Group Title	Sayana
Arm/Group Description	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.
Period Title: Overall Study
STARTED	362
Safety Population	337
COMPLETED	185
NOT COMPLETED	177

Baseline Characteristics

Arm/Group Title	Sayana
Arm/Group Description	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 Participants	337
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.92 (8.62)
Sex: Female, Male (Count of Participants)
Female	337 100%
Male	0 0%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Sayana
Arm/Group Description	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.
Measure Participants	337
AEs	81 24%
SAEs	1 0.3%

2. Primary Outcome

Title	Number of Participants Discontinued From Study Due to AEs
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Sayana
Arm/Group Description	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.
Measure Participants	337
Count of Participants [Participants]	22 6.5%

3. Primary Outcome

Title	Number of Participants Used Concomitant Medications for Treating AEs
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Sayana
Arm/Group Description	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.
Measure Participants	337
Count of Participants [Participants]	54 16%

4. Primary Outcome

Title	Number of Participants With Clinically Significant Laboratory Test Abnormalities
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Sayana
Arm/Group Description	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.
Measure Participants	337
Count of Participants [Participants]	0 0%

5. Primary Outcome

Title	Percentage of Participants Who Became Pregnant Over Observation Period
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Sayana
Arm/Group Description	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.
Measure Participants	182
Number (95% Confidence Interval) [percentage of participants]	0 0%

6. Primary Outcome

Title	Rate of Pregnancies Per 100 Participant-years of Follow-up
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Sayana
Arm/Group Description	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.
Measure Participants	182
Number (95% Confidence Interval) [pregnancies per 100 participant-years]	0

7. Primary Outcome

Title	Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of First Dose (Month 3) of Study Drug
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Sayana
Arm/Group Description	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.
Measure Participants	144
Baseline	48.32 (31.9)
Change at Month 3	-29.63 (29.31)

8. Primary Outcome

Title	Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Second Dose (Month 6) of Study Drug
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Sayana
Arm/Group Description	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.
Measure Participants	105
Mean (Standard Deviation) [millimeter]	-33.02 (30.8)

9. Primary Outcome

Title	Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Third Dose (Month 9) of Study Drug
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Sayana
Arm/Group Description	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.
Measure Participants	10
Mean (Standard Deviation) [millimeter]	-37.8 (30.7)

10. Primary Outcome

Title	Change From Baseline in in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Fourth Dose (Month 12) of Study Drug
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Sayana
Arm/Group Description	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.
Measure Participants	4
Mean (Standard Deviation) [millimeter]	-49.25 (29.98)

Adverse Events

Time Frame	Baseline up to a maximum of 12 months
Adverse Event Reporting Description	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.
Arm/Group Title	Sayana
Arm/Group Description	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.
All Cause Mortality
	Sayana
	Affected / at Risk (%)	# Events
Total	0/337 (0%)
Serious Adverse Events
	Sayana
	Affected / at Risk (%)	# Events
Total	1/337 (0.3%)
Reproductive system and breast disorders
Vaginal haemorrhage	1/337 (0.3%)
Other (Not Including Serious) Adverse Events
	Sayana
	Affected / at Risk (%)	# Events
Total	80/337 (23.7%)
Cardiac disorders
Flushing	1/337 (0.3%)
General disorders
Pelvic pain	1/337 (0.3%)
Immune system disorders
Common cold	1/337 (0.3%)
Metabolism and nutrition disorders
Weight increase	3/337 (0.9%)
Musculoskeletal and connective tissue disorders
Skeletal pain	1/337 (0.3%)
Nervous system disorders
Headache	1/337 (0.3%)
Tremor	1/337 (0.3%)
Reproductive system and breast disorders
Amenorrhoea	13/337 (3.9%)
Breast pain	1/337 (0.3%)
Metrorrhagia	3/337 (0.9%)
Vaginal haemorrhage	58/337 (17.2%)
Skin and subcutaneous tissue disorders
Alopecia	1/337 (0.3%)
Pruritus	1/337 (0.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.