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Post Marketing Surveillance To Observe Safety And Efficacy Of Duavive

Last updated on October 11, 2018

FOR MORE INFORMATION
Study Location
Kyungpook National University/Department of Internal Medicine (Cardiology)
Jung-gu, Daegu, 700-721 Korea, Republic of
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Severe Vasomotor Symptom Associated With Menopause
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Severe post menopausal vasomotor symptoms with uterus

2. postmenopausal osteopenia

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

- Women with undiagnosed abnormal uterine bleeding

- Women with known, suspected, or past history of breast cancer

- Women with known or suspected estrogen-dependent neoplasia

- Women with active deep venous thrombosis, pulmonary embolism, or history of these
conditions

- Women with active arterial thromboembolic disease (for example, stroke, myocardial
infarction) or history of these conditions

- Women who are receiving progestin, estrogen, or estrogen-agonists/antagonists

- Women with hypersensitivity (for example, anaphylaxis, angioedema) to estrogens,
bazedoxifene, or any ingredients

- Women with known hepatic impairment or disease

- Women with known protein C, protein S, or antithrombin deficiency or other known
thrombophilic disorders

- Pregnant women, women who may become pregnant, and nursing mothers

- Women with hereditary problems of galactose intolerance, Lapp lactase deficiency or
glucose galactose malabsorption.

NCT02792504
Pfizer
Recruiting
Post Marketing Surveillance To Observe Safety And Efficacy Of Duavive

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Not Provided
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Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Probability Sample
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Severe Vasomotor Symptom Associated With Menopause
Not Provided
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*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
January 2019
January 1, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Severe post menopausal vasomotor symptoms with uterus
  2. postmenopausal osteopenia

Exclusion Criteria:

  • Women with undiagnosed abnormal uterine bleeding
  • Women with known, suspected, or past history of breast cancer
  • Women with known or suspected estrogen-dependent neoplasia
  • Women with active deep venous thrombosis, pulmonary embolism, or history of these conditions
  • Women with active arterial thromboembolic disease (for example, stroke, myocardial infarction) or history of these conditions
  • Women who are receiving progestin, estrogen, or estrogen-agonists/antagonists
  • Women with hypersensitivity (for example, anaphylaxis, angioedema) to estrogens, bazedoxifene, or any ingredients
  • Women with known hepatic impairment or disease
  • Women with known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders
  • Pregnant women, women who may become pregnant, and nursing mothers
  • Women with hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption.
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
20 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Korea, Republic of
 
 
NCT02792504
B2311067
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 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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