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OpenTrials
Completed

NCT Number: NCT02792504

Post Marketing Surveillance To Observe Safety And Efficacy Of Duavive

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

Completed

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Key information

Conditions

Severe Vasomotor Symptom Associated With Menopause

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Kyungpook National University/Department of Internal Medicine (Cardiology), Jung-gu, Daegu, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Severe post menopausal vasomotor symptoms with uterus
  • 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.

Treatment and study plan

Primary outcomes

  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Baseline up to 28 days after last dose of study drug (up to 22 months)

    An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. AEs included both serious and all non-serious adverse events.

  2. Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Baseline up to 28 days after last dose of study drug (up to 22 months)

    An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. A treatment-related adverse event was any untoward medical occurrence attributed to Duavive tablet in a participant who received Duavive tablet. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Duavive tablet was assessed by the investigator.

  3. Number of Participants Classified According to Measures Taken for Adverse Events

    Time frame: Baseline up to 28 days after last dose of study drug (up to 22 months)

    An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Following measures were taken for AEs in relation to Duavive tablet: no change in treatment, permanently discontinued treatment and temporarily discontinued treatment.

  4. Number of Participants With Change From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Month 3

    Time frame: Baseline, Month 3

    Change from baseline in moderate to severe vasomotor symptoms associated with menopause was judged by investigator based on recorded symptoms and classified as "Effectiveness" when symptoms improved and as "Ineffectiveness" when there was no change in symptoms or symptoms aggravated.

  5. Number of Participants With Change From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Month 6

    Time frame: Baseline, Month 6

    Change from baseline in moderate to severe vasomotor symptoms associated with menopause was judged by investigator based on recorded symptoms and classified as "Effectiveness" when symptoms improved and as "Ineffectiveness" when there was no change in symptoms or symptoms aggravated.

  6. Percentage of Participants With Improvement From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Last Visit

    Time frame: Baseline, Last visit (last visit was anytime up to a maximum of Month 21)

    Improvement from baseline in moderate to severe vasomotor symptoms associated with menopause was judged by investigator based on recorded symptoms and classified as "Effectiveness" when symptoms improved.

  7. Number of Participants With Prevention of Post-menopausal Osteoporosis at Month 3

    Time frame: Month 3

    Investigator evaluated preventive effect of Duavive treatment based on comparing results of following at baseline and specified visit: X-ray examination, bone density test record, other blood test record related to resorption of bone and osteogenesis. In this outcome measure, data of only those participants in which Duavive treatment was effective in prevention of post-menopausal osteoporosis is reported.

  8. Number of Participants With Prevention of Post-menopausal Osteoporosis at Month 6

    Time frame: Month 6

    Investigator evaluated preventive effect of Duavive treatment based on comparing results of following at baseline and specified visit: X-ray examination, bone density test record, other blood test record related to resorption of bone and osteogenesis. In this outcome measure, data of only those participants in which Duavive treatment was effective in prevention of post-menopausal osteoporosis is reported.

  9. Percentage of Participants With Prevention of Post-menopausal Osteoporosis at Last Visit

    Time frame: Last visit (last visit was anytime up to a maximum of Month 21)

    Investigator evaluated preventive effect of Duavive treatment based on comparing results of following at baseline and specified visit: X-ray examination, bone density test record, other blood test record related to resorption of bone and osteogenesis. In this outcome measure, data of only those participants in which Duavive treatment was effective in prevention of post-menopausal osteoporosis is reported.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

POST MARKETING SURVEILLANCE TO OBSERVE THE SAFETY AND EFFICACY OF DUAVIVE TAB 0.45MG/20MG

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 7, 2016
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.