N/A
Completed N=669
Post Marketing Surveillance To Observe Safety And Efficacy Of Duavive
Severe Vasomotor Symptom Associated With Menopause
Source: ClinicalTrials.gov NCT02792504 ↗
Enrolled (actual)
669
Serious AEs
0.3%
Results posted
Aug 2021
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 73; 2 Participants
Summary
To evaluate safety and efficacy of CE/BZA in real practice in Korea
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
73; 2 | — |
| PRIMARY Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) |
58; 0 | — |
| PRIMARY Number of Participants Classified According to Measures Taken for Adverse Events |
19; 53; 1 | — |
| PRIMARY Number of Participants With Change From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Month 3 |
319; 68 | — |
| PRIMARY Number of Participants With Change From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Month 6 |
118; 23 | — |
| PRIMARY Percentage of Participants With Improvement From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Last Visit |
82.31 | — |
| PRIMARY Number of Participants With Prevention of Post-menopausal Osteoporosis at Month 3 |
17 | — |
| PRIMARY Number of Participants With Prevention of Post-menopausal Osteoporosis at Month 6 |
1 | — |
| PRIMARY Percentage of Participants With Prevention of Post-menopausal Osteoporosis at Last Visit |
77.27 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02792504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.