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Trial record 37 of 153 for:    Recruiting, Not yet recruiting, Available Studies | menopause

Post Marketing Surveillance To Observe Safety And Efficacy Of Duavive

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ClinicalTrials.gov Identifier: NCT02792504
Recruitment Status : Recruiting
First Posted : June 7, 2016
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease
Severe Vasomotor Symptom Associated With Menopause

Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Marketing Surveillance To Observe Safety And Efficacy Of Duavive Tab 0.45mg/20mg
Actual Study Start Date : January 23, 2016
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : January 1, 2019



Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 30 days after last dose ]

    Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.

    Percentage of participants discontinued from study


  2. Vasomotor System Assessment [ Time Frame: 30 days after last dose ]
    Measured as follows (improved, no change, aggravated), investigators judgment on the improvement of the symptom recorded during the treatment.

  3. Osteopenia Assessment [ Time Frame: 30 days after last dose ]
    Measured as follows (improved, no change, aggravated), investigators judgment on clincal response at post treatment and relevant lab data(if collected)from medical record during the treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
General hospital and Primary clinic in Korea
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02792504


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
Korea, Republic of
Kyungpook National University/Department of Internal Medicine (Cardiology) Active, not recruiting
Jung-gu, Daegu, Korea, Republic of, 700-721
Dr. Wang's OB & GY Clinic Active, not recruiting
Seoul, Dobong-gu, Korea, Republic of, 01432
Kimhyeonmi OBGY Active, not recruiting
Hwaseong-si, Dongtan, Korea, Republic of, 18442
Korea University Ansan Hospital Recruiting
Ansan, Gyeonggi-do, Korea, Republic of, 425-707
Baylor Ewha Obgyn Clinic Active, not recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-811
Dongguk University Ilsan Medical Center Obstetrics Active, not recruiting
Goyang-si, Ilsandong-gu, Korea, Republic of, 10326
Obstetrics / Grace Women's Hospital Active, not recruiting
Goyong-si, Ilsandong-gu, Korea, Republic of, 10447
Kyungpook National University Hospital, Obstetrics Recruiting
Daegu, Jung-gu, Korea, Republic of, 41940
Pusan University Hospital Obstetrics Active, not recruiting
Pusan, Seo-gu, Korea, Republic of, 602 739
Catholic Universith of Korea, Seoul ST. Mary's Hospital Recruiting
Seoul, Seocho-gu, Korea, Republic of, 06591
Samsung Medical Center, Sungkyunkwan Univ. School of Medicine Active, not recruiting
Kangnam-ku, Seoul, Korea, Republic of, 135-710
Seoul National University Hospital / Department of Internal Medicine Active, not recruiting
Seoul, Korea, Republic of, 110-744
Severance Hospital, Yonsei University Health System Active, not recruiting
Seoul, Korea, Republic of, 120-752
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138 736
Sanggye Paik Hospital-Inje University Active, not recruiting
Seoul, Korea, Republic of, 139-707
Konkuk University Medical Center Active, not recruiting
Seoul, Korea, Republic of, 143-729
Chungang University Hospital Active, not recruiting
Seoul, Korea, Republic of, 156-755
AJOU University Hospital Recruiting
Suwon, Korea, Republic of, 443-380
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer