You are here

Post Marketing Surveillance To Observe Safety And Efficacy Of Duavive

Last updated on November 13, 2019

FOR MORE INFORMATION
Study Location
Dr. Wang's OB & GY Clinic
Seoul, Dobong-gu, 01432 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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Severe Vasomotor Symptom Associated With Menopause
NCT02792504
Females
20+
Years
Multiple Sites
Descriptive Information
Brief TitlePost Marketing Surveillance To Observe Safety And Efficacy Of Duavive
Official TitlePOST MARKETING SURVEILLANCE TO OBSERVE THE SAFETY AND EFFICACY OF DUAVIVE TAB 0.45MG/20MG
Brief SummaryTo evaluate safety and efficacy of CE/BZA in real practice in Korea
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationGeneral hospital and Primary clinic in Korea
ConditionSevere Vasomotor Symptom Associated With Menopause
InterventionNot Provided
Study Groups/CohortsNot Provided
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: June 1, 2016)
600
Original Estimated EnrollmentSame as current
Estimated Study Completion DateNovember 2019
Estimated Primary Completion DateNovember 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study:Female
Gender Based Eligibility:Yes
Ages20 Years and older   (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 NumberNCT02792504
Other Study ID NumbersB2311067
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 DateSeptember 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]

Call Now