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Post Marketing Surveillance Study For Sayana®

Last updated on November 13, 2019

FOR MORE INFORMATION
Study Location
Inje University Haeundae Paik Hospital
Haeundae-gu, Busan, 48108 Korea, Republic of
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Postmarketing Product Surveillance
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02104557
Pfizer
Recruiting
Post Marketing Surveillance Study For Sayana®

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Postmarketing Product Surveillance
NCT02104557
Females
0+
Years
Multiple Sites
Descriptive Information
Brief TitlePost Marketing Surveillance Study For Sayana®
Official TitlePOST MARKETING SURVEILLANCE TO OBSERVE SAFETY AND EFFICACY OF SAYANA(REGISTERED) USED FOR CONTRACEPTION AND MANAGEMENT OF ENDOMETRIOSIS-ASSOCIATED PAIN
Brief SummaryPost Marketing Surveillance To Observe Safety And Efficacy Of Sayana® Used For Contraception And Management Of Endometriosis-Associated Pain
Detailed DescriptionPost Marketing Surveillance required by Korea MFDS regulation. Select among patients who randomly visit the site who meet the inclusion/exclusion criteria.
Study TypeObservational
Study DesignObservational Model: Other
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationWomen subjects who are initiating treatment with Sayana® for the first time as per the local product document for usage
ConditionProduct Surveillance, Postmarketing
InterventionOther: Non intervention
Non intervention
Study Groups/Cohorts
  • prevention of pregnancy
    Non intervention
    Intervention: Other: Non intervention
  • management of endometriosis-associated pain
    Non intervention
    Intervention: Other: Non intervention
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusRecruiting
Estimated Enrollment
 (submitted: April 1, 2014)
600
Original Estimated EnrollmentSame as current
Estimated Study Completion DateAugust 25, 2020
Estimated Primary Completion DateAugust 25, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study:Female
Gender Based Eligibility:Yes
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location CountriesKorea, Republic of
Removed Location Countries  
 
Administrative Information
NCT NumberNCT02104557
Other Study ID NumbersA6791036
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description: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/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2019

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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