Hot FlashesPhase 3NCT00185237
Treatment of Hot Flushes in Asian Women With Ultra-low Dose Estradiol Patch
A Phase 3 study testing Menostar (estradiol transdermal delivery system) in people with Hot Flashes, run by Bayer.
Trial summary
150 postmenopausal Asian women with vasomotor symptoms, after fulfilling the inclusion and exclusion criteria will be enrolled in the study. The women will be randomly assigned to one of two treatment groups (Menostar® or placebo), after which they will be asked to use a patch once a week for 12 weeks. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Hot Flashes
- What is being tested?
- Menostar (estradiol transdermal delivery system)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to Nov 2006
- 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
- Evidence of postmenopausal status
Who cannot join
- Contraindication to estrogen therapy
About this study
Official title: A Multicenter, Double-blind, Randomized, Placebo Controlled Study on the Effect of Ultra-low Dose Transdermal Estradiol (Menostar®) on the Incidence and Severity of Hot Flushes, Other Menopausal Symptoms and on Well-being in Postmenopausal Asian Women Over 12 Weeks.
150 postmenopausal Asian women with vasomotor symptoms, after fulfilling the inclusion and exclusion criteria will be enrolled in the study. The women will be randomly assigned to one of two treatment groups (Menostar® or placebo), after which they will be asked to use a patch once a week for 12 weeks.
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
- Hot Flashes
- Being tested
- Menostar (estradiol transdermal delivery system), Placebo
- Keywords
- Menopause
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menostar (estradiol transdermal delivery system)Drug
Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)
PlaceboDrug
Placebo patch
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Menostar (estradiol transdermal delivery system) |
| Arm 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change in frequency of hot flushes
Measured: 12 weeks
Secondary outcomes (7)
Change in intensity of hot flushes
Measured: 12 weeks
Changes in vaginal pH
Measured: 12 weeks
Changes in vaginal maturation index
Measured: 12 weeks
Occurrence of urogenital symptoms
Measured: 12 weeks
Change in MENQOL (menopausal quality of life questionaire)
Measured: 12 weeks
Bleeding profile
Measured: 12 weeks
Safety
Measured: 12 weeks
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 startJul 2005
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 165 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
- NCT00185237
- Sponsor's protocol ID
- 91441
- Other IDs
- 309120
- Status last verified
- Dec 2014
- First submitted
- 9 Sep 2005
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Placebo Controlled Study on the Effect of Ultra-low Dose Transdermal Estradiol (Menostar®) on the Incidence and Severity of Hot Flushes, Other Menopausal Symptoms and on Well-being in Postmenopausal Asian Women Over 12 Weeks.
- ClinicalTrials.gov ID
- NCT00185237
- Acronym / sponsor ID
- 91441
- Conditions
- Hot Flashes
- Keywords
- Menopause
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 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.
150 postmenopausal Asian women with vasomotor symptoms, after fulfilling the inclusion and exclusion criteria will be enrolled in the study. The women will be randomly assigned to one of two treatment groups (Menostar® or placebo), after which they will be asked to use a patch once a week for 12 weeks.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Menostar (estradiol transdermal delivery system) |
| Arm 2 | Placebo comparator | Drug: Placebo |
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)
- Evidence of postmenopausal status
Key exclusion criteria (1 listed)
- Contraindication to estrogen therapy
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 |
|---|---|---|
| Menostar (estradiol transdermal delivery system)Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day) | Drug | Arm 1 |
| PlaceboPlacebo patch | Drug | Arm 2 |
Primary outcome
Relative change in frequency of hot flushes
Time frame: 12 weeks
7 secondary outcomes
Change in intensity of hot flushes
Time frame: 12 weeks
Changes in vaginal pH
Time frame: 12 weeks
Changes in vaginal maturation index
Time frame: 12 weeks
Occurrence of urogenital symptoms
Time frame: 12 weeks
Change in MENQOL (menopausal quality of life questionaire)
Time frame: 12 weeks
Bleeding profile
Time frame: 12 weeks
Safety
Time frame: 12 weeks
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 23 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
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Menostar (estradiol transdermal delivery system) in people with Hot Flashes, 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 23 Dec 2014. 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. 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?
Relative change in frequency of hot flushes (time frame: 12 weeks). 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 23 Dec 2014.