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Post Marketing Surveillance To Observe Safety And Efficacy Of Duavive

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Pfizer

Status

Completed

Conditions

Severe Vasomotor Symptom Associated With Menopause

Study type

Observational

Funder types

Industry

Identifiers

NCT02792504
B2311067

Details and patient eligibility

About

To evaluate safety and efficacy of CE/BZA in real practice in Korea

Enrollment

669 patients

Sex

Female

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Trial documents
2

Trial contacts and locations

20

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Data sourced from clinicaltrials.gov

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