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Post Marketing Surveillance Study For Sayana®

Last updated on May 18, 2018

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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[email protected]

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Post Marketing Surveillance required by Korea MFDS regulation. Select among patients who randomly visit the site who meet the inclusion/exclusion criteria.
Observational
Observational Model: Other
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Women subjects who are initiating treatment with Sayana® for the first time as per the local product document for usage
Product Surveillance, Postmarketing
Other: Non intervention
Non intervention
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Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
October 28, 2018
October 28, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Child, Adult, Senior
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Korea, Republic of
 
 
NCT02104557
A6791036
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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