CompletedNot Applicable

Post Marketing Surveillance To Observe Safety And Efficacy Of Duavive

South Korea669 participantsStarted 2016-03-29

Plain-language summary

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

Who can participate

Age range

20 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Severe post menopausal vasomotor symptoms with uterus
. postmenopausal osteopenia

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

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

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

Number of Participants Classified According to Measures Taken for Adverse Events

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

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

Timeframe: Baseline, Month 3

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

Timeframe: Baseline, Month 6

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

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

Trial details

NCT IDNCT02792504

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-07-22

Results submitted2021-07-13

View on ClinicalTrials.gov More Severe Vasomotor Symptom Associated With Menopause trials

What they're measuring

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

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

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

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

Number of Participants Classified According to Measures Taken for Adverse Events

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

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

Timeframe: Baseline, Month 3

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

Timeframe: Baseline, Month 6

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

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