Hot FlashesPhase 3NCT01389102
Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms
A Phase 3 study testing Estradiol transdermal one 90 μL spray, Estradiol transdermal spray, two 90 μL sprays and Estradiol transdermal three 90 μL sprays in people with Hot Flashes, run by Lumara Health, Inc. at 43 sites in United States.
Trial summary
Estradiol treatment is effective at reducing vasomotor symptoms (eg hot flushes) in postmenopausal women. This study will evaluate the safety and efficacy of Evamist. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Hot Flashes
- What is being tested?
- Estradiol transdermal one 90 μL spray, Estradiol transdermal spray, two 90 μL sprays and Estradiol transdermal three 90 μL sprays
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 454 participants
- Where
- 43 sitesUnited States
- Study dates
- Dec 2004to Nov 2006
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post menopausal women,
- Ages 35 or older,
- Frequent moderate to severe hot flushes,
- Qualifying general medical health
Who cannot join
- Disqualifying gynecological disorders,
- Disqualifying dermatological disorders,
- Disqualifying concurrent conditions
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
Radiant Research
Atlanta, Georgia, 30342
Benchmark Research
Austin, Texas, 78705
South Florida Medical Research
Aventura, Florida, 33180
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235
Mid Dakota Clinic
Bismarck, North Dakota, 58501
Ridgeview Research
Chaska, Minnesota, 55318
Radiant Research
Chicago, Illinois, 60610
Radiant Research
Cincinnati, Ohio, 45236
Radiant Research
Columbus, Ohio, 43212
Advanced Research Associates
Corpus Christi, Texas, 78414
Downtown Women's Health Care
Denver, Colorado, 80202
Atlanta West Women's Center
Douglasville, Georgia, 30134
TriPhase Research
Franklin, Ohio, 45005
Center for Women's Medicine
Greenville, South Carolina, 29605
Baylor College of Medicine
Houston, Texas, 77033
NEA Womens Clinic
Jonesboro, Arkansas, 72401
Women's Health Research Ctr.
Laurel, Maryland, 20707
Arkansas Women's Center
Little Rock, Arkansas, 72205
PMG-South/OB-Gyn Health Ctr.
Medford, Oregon, 97504
Benchmark Research
Metairie, Louisiana, 70002
Clinical Trials Management
Metairie, Louisiana, 70006
Costal Clinical Research
Mobile, Alabama, 36608
Radiant Research
Mogadore, Ohio, 44260
Clinical Research Associates
Nashville, Tennessee, 37203
University of Eastern Virginia
Norfold, Virginia, 23507
Renstar Medical Research
Ocala, Florida, 34471
Meridian Clinical Research
Omaha, Nebraska, 68134
Harmony Clinic
Oro Valley, Arizona, 85739
Hope Research Institute
Phoenix, Arizona, 85032
Radiant Research
Phoenix, Arizona, 85032
Radiant Research
Pinellas Park, Florida, 33781
Speciality Care for Women
Redding, California, 96001
Sacramento Research Medical Grp
Sacramento, California, 95825
J. Lewis Research
Salt Lake City, Utah, 84109
Radiant Research
San Antonio, Texas, 78229
Dr. Steven Drosman
San Diego, California, 92103
Medical Center for Clinical Research
San Diego, California, 92108
Benchmark Research
San Francisco, California, 94102
Pacific Clinical Research
Santa Monica, California, 90404
Tacoma Women's Specialists
Tacoma, Washington, 98405
Radiant Research
Tucson, Arizona, 85701
Diablo Clinical Research
Walnut Creek, California, 94598
Comprehensive Clinical Trials
West Palm Beach, Florida, 33409
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Estradiol Metered-Dose Transdermal Spray (MDTS) in the Treatment of Vasomotor Symptoms in Postmenopausal Women
Estradiol treatment is effective at reducing vasomotor symptoms (eg hot flushes) in postmenopausal women. This study will evaluate the safety and efficacy of Evamist.
Read the detailed description
Multicenter, randomized, double-blind, placebo-controlled trial evaluating different doses of transdermal estradiol delivered by sray to symptomatic postmenopausal women. The endpoints are the reduction in frequency and severity of hot flushes.
- Conditions
- Hot Flashes
- Being tested
- Estradiol transdermal one 90 μL spray, Estradiol transdermal spray, two 90 μL sprays, Estradiol transdermal three 90 μL sprays, Placebo transdermal two 90 μL sprays, Placebo transdermal three 90 μL sprays
- Keywords
- Postmenopause, Hot Flashes, Estradiol, Polyestradiol phosphate, Estradiol valerate, Estradiol 3-benzoate, Estradiol 17 beta-cypionate, Estrogens, Hormones, Hormones, Hormone Substitutes, Hormone Antagonists
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol transdermal one 90 μL sprayDrug
Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
Estradiol transdermal spray, two 90 μL spraysDrug
Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
Estradiol transdermal three 90 μL spraysDrug
Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
Placebo transdermal two 90 μL spraysDrug
Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
Placebo transdermal three 90 μL spraysDrug
Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
Placebo transdermal one 90 μL sprayDrug
Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
| Study group | Role | What they receive |
|---|---|---|
| Placebo transdermal three 90 μL sprays | Placebo comparator | Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator Receives: Drug: Placebo transdermal three 90 μL sprays |
| Placebo transdermal two 90 μL sprays | Placebo comparator | Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator Receives: Drug: Placebo transdermal two 90 μL sprays |
| Placebo transdermal one 90 μL spray | Placebo comparator | Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator Receives: Drug: Placebo transdermal one 90 μL spray |
| Estradiol transdermal three 90 μL sprays | Active comparator | Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator Receives: Drug: Estradiol transdermal three 90 μL sprays |
| Estradiol transdermal two 90 μL sprays | Active comparator | Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator Receives: Drug: Estradiol transdermal spray, two 90 μL sprays |
| Estradiol transdermal one 90 μL spray | Active comparator | Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator Receives: Drug: Estradiol transdermal one 90 μL spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in the Number of Moderate to Severe Vasomotor Symptoms Per Day
Patients completed a daily diary to record the number of mild, moderate and number of moderate or severe vasomotor symptoms [hot flushes and sweating] experienced each day.
Mild, moderate and severe hot flushes and sweating were defined as follows:
Mild = sensation of heat without sweating Moderate = sensation of heat with sweating, ability to continue activity Severe = sensation of heat with sweating, causing discontinuation of activity
Measured: baseline to week 12
Mean Change the Severity of Moderate to Severe Vasomotor Symptoms
Patients completed a daily diary to record the number of mild, moderate and severe vasomotor symptoms experienced each day.
Mild, moderate and severe were defined as follows:
Mild = sensation of heat without sweating Moderate = sensation of heat with sweating, ability to continue activity Severe = sensation of heat with sweating, causing discontinuation of activity Severity of hot flushes was measured on a scale of none = 0, mild = 1, moderate = 2 and severe = 3.
Measured: baseline to week 12 (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2011 (estimated)
- Study startDec 2004
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- 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
- 454 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumara Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389102
- Sponsor's protocol ID
- EST-01
- Status last verified
- Jun 2012
- First submitted
- 5 Jul 2011
- Last updated
- 11 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Buster JE, Koltun WD, Pascual ML, Day WW, Peterson C. Low-dose estradiol spray to treat vasomotor symptoms: a randomized controlled trial. Obstet Gynecol. 2008 Jun;111(6):1343-51. doi: 10.1097/AOG.0b013e318175d162.
PubMed 18515518
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Estradiol Metered-Dose Transdermal Spray (MDTS) in the Treatment of Vasomotor Symptoms in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01389102
- Acronym / sponsor ID
- EST-01
- Conditions
- Hot Flashes
- Keywords
- Postmenopause, Hot Flashes, Estradiol, Polyestradiol phosphate, Estradiol valerate, Estradiol 3-benzoate, Estradiol 17 beta-cypionate, Estrogens
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 454 participants (actual)
- Lead sponsor
- Lumara Health, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 7 Jul 2011 (estimated)
- Results
- Posted 11 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Estradiol treatment is effective at reducing vasomotor symptoms (eg hot flushes) in postmenopausal women. This study will evaluate the safety and efficacy of Evamist.
Detailed description
Multicenter, randomized, double-blind, placebo-controlled trial evaluating different doses of transdermal estradiol delivered by sray to symptomatic postmenopausal women. The endpoints are the reduction in frequency and severity of hot flushes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo transdermal three 90 μL sprays | Placebo comparator | Drug: Placebo transdermal three 90 μL spraysPlacebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator |
| Placebo transdermal two 90 μL sprays | Placebo comparator | Drug: Placebo transdermal two 90 μL spraysPlacebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator |
| Placebo transdermal one 90 μL spray | Placebo comparator | Drug: Placebo transdermal one 90 μL sprayPlacebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator |
| Estradiol transdermal three 90 μL sprays | Active comparator | Drug: Estradiol transdermal three 90 μL spraysEstradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator |
| Estradiol transdermal two 90 μL sprays | Active comparator | Drug: Estradiol transdermal spray, two 90 μL spraysEstradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator |
| Estradiol transdermal one 90 μL spray | Active comparator | Drug: Estradiol transdermal one 90 μL sprayEstradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Post menopausal women,
- Ages 35 or older,
- Frequent moderate to severe hot flushes,
- Qualifying general medical health
Key exclusion criteria (3 listed)
- Disqualifying gynecological disorders,
- Disqualifying dermatological disorders,
- Disqualifying concurrent conditions
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 transdermal one 90 μL sprayEstradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator | Drug | Estradiol transdermal one 90 μL spray |
| Estradiol transdermal spray, two 90 μL spraysEstradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator | Drug | Estradiol transdermal two 90 μL sprays |
| Estradiol transdermal three 90 μL spraysEstradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator | Drug | Estradiol transdermal three 90 μL sprays |
| Placebo transdermal two 90 μL spraysPlacebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator | Drug | Placebo transdermal two 90 μL sprays |
| Placebo transdermal three 90 μL spraysPlacebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator | Drug | Placebo transdermal three 90 μL sprays |
| Placebo transdermal one 90 μL sprayPlacebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator | Drug | Placebo transdermal one 90 μL spray |
Primary outcome
Mean Change in the Number of Moderate to Severe Vasomotor Symptoms Per Day
Time frame: baseline to week 12
Patients completed a daily diary to record the number of mild, moderate and number of moderate or severe vasomotor symptoms [hot flushes and sweating] experienced each day. Mild, moderate and severe hot flushes and sweating were defined as follows: Mild = sensation of heat without sweating Moderate = sensation of heat with sweating, ability to continue activity Severe = sensation of heat with sweating, causing discontinuation of activity
Mean Change the Severity of Moderate to Severe Vasomotor Symptoms
Time frame: baseline to week 12 (12 weeks)
Patients completed a daily diary to record the number of mild, moderate and severe vasomotor symptoms experienced each day. Mild, moderate and severe were defined as follows: Mild = sensation of heat without sweating Moderate = sensation of heat with sweating, ability to continue activity Severe = sensation of heat with sweating, causing discontinuation of activity Severity of hot flushes was measured on a scale of none = 0, mild = 1, moderate = 2 and severe = 3.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 18515518Buster JE, Koltun WD, Pascual ML, Day WW, Peterson C. Low-dose estradiol spray to treat vasomotor symptoms: a randomized controlled trial. Obstet Gynecol. 2008 Jun;111(6):1343-51. doi: 10.1097/AOG.0b013e318175d162.
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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.
The record lists no contact. Use the official record to reach the sponsor.
43 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 Estradiol transdermal one 90 μL spray, Estradiol transdermal spray, two 90 μL sprays and Estradiol transdermal three 90 μL sprays in people with Hot Flashes, run by Lumara Health, Inc. at 43 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 4 inclusion and 3 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 11 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 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 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?
Yes. Results are posted in the registry (first posted 11 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change in the Number of Moderate to Severe Vasomotor Symptoms Per Day (time frame: baseline to week 12). The study lists 2 primary outcomes in all. 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 NCT01389102, 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 11 Jun 2012.