Hot FlashesPhase 4NCT00206622
Efficacy and Safety Study in Postmenopausal Women to Determine the Lowest Effective Dose for Relief of Moderate to Severe Hot-Flushes
A Phase 4 study testing Climara PRO (Estradiol / Levonorgestrel transdermal) and Menostar (Estradiol transdermal) in people with Hot Flashes, run by Bayer at 45 sites in United States.
Trial summary
To determine the lowest effective dose of estradiol by comparing E2/LNG (2.2mg/0.69mg) and E2 (1.0mg) dose with placebo in decreasing the frequency and severity of moderate to severe hot flushes in postmenopausal women Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Hot Flashes
- What is being tested?
- Climara PRO (Estradiol / Levonorgestrel transdermal) and Menostar (Estradiol transdermal)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 425 participants
- Where
- 45 sitesUnited States
- Study dates
- Dec 2004to Feb 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Menopause
- Reporting a minimum of 7 moderate to severe hot flushes per day for at least 1 week (7 consecutive days), or a minimum of 50 moderate to severe hot flushes per week for at least 1 week (7 consecutive days)
Who cannot join
- Hormonal treatment
- Contraindication to estrogen/progestogen therapy
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
United States45 sites
Study site
Albuquerque, New Mexico, 87102
Study site
Alpharetta, Georgia, 30005
Study site
Arlington, Texas, 76012
Study site
Boise, Idaho, 83702
Study site
Burlington, Vermont, 05401-1420
Study site
Champaign, Illinois, 61820
Study site
Chandler, Arizona, 85225
Study site
Chicago, Illinois, 60612
Study site
Cincinnati, Ohio, 45236
Study site
Cleveland, Ohio, 44122
Study site
Columbus, Ohio, 43213
Study site
Detroit, Michigan, 48201
Study site
Fair Oaks, California, 95628
Study site
Fort Myers, Florida, 33916
Study site
Gainesville, Florida, 32610-0254
Study site
Houston, Texas, 77004
Study site
Houston, Texas, 77030
Study site
Huntsville, Alabama, 35801
Study site
Idaho Falls, Idaho, 83404
Study site
Jacksonville, Florida, 32216
Study site
Lexington, Kentucky, 40536
Study site
Lincoln, Nebraska, 68510
Study site
Memphis, Tennessee, 38120
Study site
New Britain, Connecticut, 06050
Study site
New Brunswick, New Jersey, 08901
Study site
New Orleans, Louisiana, 70115
Study site
New Orleans, Louisiana, 70118-1034
Study site
Oakland, California, 94612
Study site
Peoria, Illinois, 61615
Study site
Philadelphia, Pennsylvania, 19114
Study site
Phoenix, Arizona, 85031
Study site
Pittsburgh, Pennsylvania, 15206
Study site
Reno, Nevada, 89502
Study site
Salt Lake City, Utah, 84124
Study site
San Diego, California, 92103
Study site
San Diego, California, 92108
Study site
San Diego, California, 92123
Study site
South Bend, Indiana, 46601
Study site
St Louis, Missouri, 63110
Study site
Tampa, Florida, 33613
Study site
Temple, Texas, 76502-1896
Study site
Tucson, Arizona, 85712
Study site
West Hartford, Connecticut, 06117
Study site
West Palm Beach, Florida, 33409
Study site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Comparing a 2.2mg 17 Beta-Estradiol/0.69mg Levonorgestrel Combination Transdermal Patch, and a 1mg 17 Beta-Estradiol Transdermal Patch With a Placebo Patch in Postmenopausal Women to Determine the Lowest Effective Dose of Estradiol for the Relief of Moderate to Severe Hot Flushes
To determine the lowest effective dose of estradiol by comparing E2/LNG (2.2mg/0.69mg) and E2 (1.0mg) dose with placebo in decreasing the frequency and severity of moderate to severe hot flushes in postmenopausal women
Read the detailed description
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.
Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.
- Conditions
- Hot Flashes
- Being tested
- Climara PRO (Estradiol / Levonorgestrel transdermal), Menostar (Estradiol transdermal), Placebo transdermal
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Climara PRO (Estradiol / Levonorgestrel transdermal)Drug
2.2mg 17 Beta-estradiol/0.69mg levonorgestrel combination transdermal patch
Menostar (Estradiol transdermal)Drug
1mg 17 Beta-estradiol transdermal patch
Placebo transdermalDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Not described Receives: Drug: Climara PRO (Estradiol / Levonorgestrel transdermal) |
| Arm 2 | Active comparator | Not described Receives: Drug: Menostar (Estradiol transdermal) |
| Arm 3 | Placebo comparator | Not described Receives: Drug: Placebo transdermal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lowest effective dose in decreasing the frequency and severity of hot flushes
Secondary outcomes (1)
Other symptoms related to menopause
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startDec 2004
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 425 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
- NCT00206622
- Sponsor's protocol ID
- 91429
- Other IDs
- 308261
- Status last verified
- May 2009
- First submitted
- 12 Sep 2005
- Last updated
- 29 May 2009
- Results posted
- No
Publications
Bachmann GA, Schaefers M, Uddin A, Utian WH. Lowest effective transdermal 17beta-estradiol dose for relief of hot flushes in postmenopausal women: a randomized controlled trial. Obstet Gynecol. 2007 Oct;110(4):771-9. doi: 10.1097/01.AOG.0000284450.51264.31.
PubMed 17906008
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Comparing a 2.2mg 17 Beta-Estradiol/0.69mg Levonorgestrel Combination Transdermal Patch, and a 1mg 17 Beta-Estradiol Transdermal Patch With a Placebo Patch in Postmenopausal Women to Determine the Lowest Effective Dose of Estradiol for the Relief of Moderate to Severe Hot Flushes
- ClinicalTrials.gov ID
- NCT00206622
- Acronym / sponsor ID
- 91429
- Conditions
- Hot Flashes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Study completion
- Feb 2006 (actual)
- First posted
- 21 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 determine the lowest effective dose of estradiol by comparing E2/LNG (2.2mg/0.69mg) and E2 (1.0mg) dose with placebo in decreasing the frequency and severity of moderate to severe hot flushes in postmenopausal women
Detailed description
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.
Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: Climara PRO (Estradiol / Levonorgestrel transdermal) |
| Arm 2 | Active comparator | Drug: Menostar (Estradiol transdermal) |
| Arm 3 | Placebo comparator | Drug: Placebo transdermal |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Menopause
- Reporting a minimum of 7 moderate to severe hot flushes per day for at least 1 week (7 consecutive days), or a minimum of 50 moderate to severe hot flushes per week for at least 1 week (7 consecutive days)
Key exclusion criteria (2 listed)
- Hormonal treatment
- Contraindication to estrogen/progestogen 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 |
|---|---|---|
| Climara PRO (Estradiol / Levonorgestrel transdermal)2.2mg 17 Beta-estradiol/0.69mg levonorgestrel combination transdermal patch | Drug | Arm 1 |
| Menostar (Estradiol transdermal)1mg 17 Beta-estradiol transdermal patch | Drug | Arm 2 |
| Placebo transdermalPlacebo | Drug | Arm 3 |
Primary outcome
Lowest effective dose in decreasing the frequency and severity of hot flushes
1 secondary outcome
Other symptoms related to menopause
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 29 May 2009.
- Derived from this study: PubMed 17906008Bachmann GA, Schaefers M, Uddin A, Utian WH. Lowest effective transdermal 17beta-estradiol dose for relief of hot flushes in postmenopausal women: a randomized controlled trial. Obstet Gynecol. 2007 Oct;110(4):771-9. doi: 10.1097/01.AOG.0000284450.51264.31.
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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
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Climara PRO (Estradiol / Levonorgestrel transdermal) and Menostar (Estradiol transdermal) in people with Hot Flashes, run by Bayer at 45 sites in United States.
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 2 inclusion and 2 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 29 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States. 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 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?
Lowest effective dose in decreasing the frequency and severity of hot flushes. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00206622, which also lists 1 linked publication.
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 29 May 2009.