Vasomotor SymptomsPhase 3NCT00651599
Treatment of Vasomotor Symptoms in Korean Post Menopausal Women
A Phase 3 study testing Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) in people with Vasomotor Symptoms, run by Bayer at 4 sites in South Korea.
Trial summary
Study to demonstrate that the therapeutic efficacy of Angeliq® is better than placebo in Korean postmenopausal women with hot flushes and other climacteric symptoms. Safety and tolerability of Angeliq. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Vasomotor Symptoms
- What is being tested?
- Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Jul 2004to May 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal Korean women suffering from hot flushes
Who cannot join
- Standard exclusion criteria for HRT clinical trials had to be obeyed, including current or history of hormone dependent malignant disease, thromboembolic disorders, abnormal cervical smear, undiagnosed vaginal bleeding.
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Study site
Seoul, 110-744
Study site
Seoul, 135-710
Study site
Seoul, 138-736
Study site
Seoul
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study Investigating the Efficacy and Tolerability of Angeliq(drospirenon2mg and Estradiol 1mg) in Postmenopausal Korean Women With Vasomotor Symptoms Over 3, 28 Day Treatment Cycle
Study to demonstrate that the therapeutic efficacy of Angeliq® is better than placebo in Korean postmenopausal women with hot flushes and other climacteric symptoms. Safety and tolerability of Angeliq.
- Conditions
- Vasomotor Symptoms
- Being tested
- Angeliq (Drospirenone/17ß-estradiol, BAY86-4891), Placebo
- Keywords
- Vasomotor symptoms, Vasomotor System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)Drug
Treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval.
PlaceboDrug
Placebo treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval.
| Study group | Role | What they receive |
|---|---|---|
| Arm 2 | Placebo comparator | Not described Receives: Drug: Placebo |
| Arm 1 | Experimental | Not described Receives: Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hot flush (frequency and severity)
Measured: Daily in pre-treatment and treatment period
Secondary outcomes (3)
Menopausal symptoms
Measured: Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment
Urogenital symptoms
Measured: Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment
Assessment of bleeding
Measured: daily in pre-treatment and treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study startJul 2004
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasomotor SymptomsStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00651599
- Sponsor's protocol ID
- 91354
- Other IDs
- 308381
- Status last verified
- Dec 2014
- First submitted
- 1 Apr 2008
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Multicenter Study Investigating the Efficacy and Tolerability of Angeliq(drospirenon2mg and Estradiol 1mg) in Postmenopausal Korean Women With Vasomotor Symptoms Over 3, 28 Day Treatment Cycle
- ClinicalTrials.gov ID
- NCT00651599
- Acronym / sponsor ID
- 91354
- Conditions
- Vasomotor Symptoms
- Keywords
- Vasomotor symptoms, Vasomotor System
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Study completion
- May 2005 (actual)
- First posted
- 3 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to demonstrate that the therapeutic efficacy of Angeliq® is better than placebo in Korean postmenopausal women with hot flushes and other climacteric symptoms. Safety and tolerability of Angeliq.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 2 | Placebo comparator | Drug: Placebo |
| Arm 1 | Experimental | Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postmenopausal Korean women suffering from hot flushes
Key exclusion criteria (1 listed)
- Standard exclusion criteria for HRT clinical trials had to be obeyed, including current or history of hormone dependent malignant disease, thromboembolic disorders, abnormal cervical smear, undiagnosed vaginal bleeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)Treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval. | Drug | Arm 1 |
| PlaceboPlacebo treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval. | Drug | Arm 2 |
Primary outcome
Hot flush (frequency and severity)
Time frame: Daily in pre-treatment and treatment period
3 secondary outcomes
Menopausal symptoms
Time frame: Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment
Urogenital symptoms
Time frame: Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment
Assessment of bleeding
Time frame: daily in pre-treatment and treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) in people with Vasomotor Symptoms, run by Bayer at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hot flush (frequency and severity) (time frame: Daily in pre-treatment and treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2014.