PostmenopausePhase 4NCT00185328
Efficacy and Tolerability of Angeliq in Thai Women
A Phase 4 study testing Estradiol/DRSP (Angeliq, BAY86-4891) in people with Postmenopause, run by Bayer.
Trial summary
To evaluate the safety, tolerability, and efficacy of Angeliq in Thai post menopausal women with hot flushes and other climacteric symptoms. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Postmenopause
- What is being tested?
- Estradiol/DRSP (Angeliq, BAY86-4891)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Dec 2006
- Phase
- Phase 4
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women with hot flushes
Who cannot join
- Women with a contraindication for Hormone Replacement Therapy (HRT)
About this study
Official title: A Multi-Center, Open-Label, Non-Comparative Study Investigating the Efficacy and Tolerability of Angeliq® in Postmenopausal Thai Women With Vasomotor Symptoms Over Three 28-Day Treatment Cycles
To evaluate the safety, tolerability, and efficacy of Angeliq in Thai post menopausal women with hot flushes and other climacteric symptoms.
Read the detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
- Conditions
- Postmenopause
- Being tested
- Estradiol/DRSP (Angeliq, BAY86-4891)
- Keywords
- Postmenopause
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol/DRSP (Angeliq, BAY86-4891)Drug
1 tablet of 2 mg drospirenone and 1 mg estradiol, orally administered once daily, over three 28-day treatment cycles
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Estradiol/DRSP (Angeliq, BAY86-4891) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relative change in the frequency of hot flushes
Measured: At baseline, week 4, 8, 12
Secondary outcomes (6)
The change in intensity of hot flushes
Measured: At baseline, week 4, 8, 12
The relative change in frequency of hot flushes
Measured: At baseline, week 4, 8
The change in intensity of hot flushes
Measured: At baseline, week 4, 8
The proportions of subjects with urogenital symptoms
Measured: At baseline, week 4, 8, 12
Bleeding pattern
Measured: At baseline, week 4, 8, 12
Adverse events collection
Measured: Collection of AE throughout the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostmenopauseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00185328
- Sponsor's protocol ID
- 91436
- Other IDs
- 309367
- Status last verified
- Dec 2008
- First submitted
- 12 Sep 2005
- Last updated
- 12 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label, Non-Comparative Study Investigating the Efficacy and Tolerability of Angeliq® in Postmenopausal Thai Women With Vasomotor Symptoms Over Three 28-Day Treatment Cycles
- ClinicalTrials.gov ID
- NCT00185328
- Acronym / sponsor ID
- 91436
- Conditions
- Postmenopause
- Keywords
- Postmenopause
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Study completion
- Dec 2006 (actual)
- First posted
- 16 Sep 2005 (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.
To evaluate the safety, tolerability, and efficacy of Angeliq in Thai post menopausal women with hot flushes and other climacteric symptoms.
Detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Estradiol/DRSP (Angeliq, BAY86-4891) |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postmenopausal women with hot flushes
Key exclusion criteria (1 listed)
- Women with a contraindication for Hormone Replacement Therapy (HRT)
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 |
|---|---|---|
| Estradiol/DRSP (Angeliq, BAY86-4891)1 tablet of 2 mg drospirenone and 1 mg estradiol, orally administered once daily, over three 28-day treatment cycles | Drug | Arm 1 |
Primary outcome
The relative change in the frequency of hot flushes
Time frame: At baseline, week 4, 8, 12
6 secondary outcomes
The change in intensity of hot flushes
Time frame: At baseline, week 4, 8, 12
The relative change in frequency of hot flushes
Time frame: At baseline, week 4, 8
The change in intensity of hot flushes
Time frame: At baseline, week 4, 8
The proportions of subjects with urogenital symptoms
Time frame: At baseline, week 4, 8, 12
Bleeding pattern
Time frame: At baseline, week 4, 8, 12
Adverse events collection
Time frame: Collection of AE throughout the study 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 12 Dec 2008.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Estradiol/DRSP (Angeliq, BAY86-4891) in people with Postmenopause, run by Bayer.
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 12 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The relative change in the frequency of hot flushes (time frame: At baseline, week 4, 8, 12). 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 12 Dec 2008.