Postmenopausal SymptomsPhase 4NCT00160173
Efficacy Study Comparing 0.9 g and 1.25 g Estrogel With Placebo for Vasomotor Symptoms and Vulvar and Vaginal Atrophy
A Phase 4 study testing Estrogel in people with Postmenopausal Symptoms, run by ASCEND Therapeutics at 109 sites in United States.
Trial summary
This study is intended to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Postmenopausal Symptoms
- What is being tested?
- Estrogel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 221 participants
- Where
- 109 sitesUnited States
- Study dates
- 2 Dec 2004to 6 Sep 2005
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women 45-65 years
- naturally or surgically postmenopausal
- experiencing hot flushes
Who cannot join
- hypersensitivity to estrogen replacement therapy
- pregnancy or lactating
- abnormal PAP smear
- history/suspected cervical, uterine, adrenal, pituitary, breast or ovarian malignancy
Trial locations and contacts
109 sites in 1 country.
109 sites in 1 country
United States109 sites
Site 61
Alpharetta, Georgia
Site 81
Alpharetta, Georgia
Site 66
Ann Arbor, Michigan
Site 28
Atlanta, Georgia
Site 93
Atlanta, Georgia
Site 35
Aventura, Florida
Site 36
Aventura, Florida
Site 69
Avon, Connecticut
Site 11
Baltimore, Maryland
Site 50
Baton Rouge, Louisiana
Site 19
Billings, Montana
Site 112
Birmingham, Alabama
Site 53
Boise, Idaho
Site 58
Bridgeport, Connecticut
Site 104
Carmichael, California
Site 83
Carrollton, Texas
Site 96
Champaign, Illinois
Site 15
Chaska, Minnesota
Site 9
Chattanooga, Tennessee
Site 24
Chicago, Illinois
Site 84
Chicago, Illinois
Site 86
Cincinnati, Ohio
Site 105
Clearwater, Florida
Site 49
Clearwater, Florida
Site 17
Conroe, Texas
Site 23
Corpus Christi, Texas
Site 25
Corpus Christi, Texas
Site 29
Creve Coeur, Missouri
Site 30
Dallas, Texas
Site 90
Dallas, Texas
Site 91
Daytona Beach, Florida
Site 55
Decatur, Georgia
Site 13
Douglasville, Georgia
Site 101
Edmond, Oklahoma
Site 42
Encinitas, California
Site 113
Erie, Pennsylvania
Site 89
Eugene, Oregon
Site 75
Evansville, Indiana
Site 31
Fayetteville, North Carolina
Site 33
Greenville, South Carolina
Site 3
Groton, Connecticut
Site 72
Hartford, Connecticut
Site 10
Houston, Texas
Site 110
Houston, Texas
Site 14
Houston, Texas
Site 27
Houston, Texas
Site 48
Houston, Texas
Site 51
Houston, Texas
Site 71
Houston, Texas
Site 73
Houston, Texas
Site 5
Jonesboro, Arkansas
Site 6
Las Vegas, Nevada
Site 108
Lexington, Kentucky
Site 56
Lincoln, Nebraska
Site 88
Little Rock, Arkansas
Site 95
Little Rock, Arkansas
Site 111
Medford, Oregon
Site 57
Melbourne, Florida
Site 92
Memphis, Tennessee
Site 12
Metairie, Louisiana
Site 109
Miami, Florida
Site 74
Mobile, Alabama
Site 20
Montgomery, Alabama
Site 76
Nashville, Tennessee
Site 60
New Bern, North Carolina
Site 54
New Britain, Connecticut
Site 65
New Orleans, Louisiana
Site 47
Norfolk, Virginia
Site102
Olean, New York
Site 26
Peoria, Illinois
Site 46
Peoria, Illinois
Site 39
Pinellas Park, Florida
Site 64
Portland, Oregon
Site 98
Pottstown, Pennsylvania
Site 87
Powder Springs, Georgia
Site 59
Raleigh, North Carolina
Site 40
Reno, Nevada
Site 106
Richmond, Virginia
Site 41
Richmond, Virginia
Site 44
Salt Lake City, Utah
Site 94
Salt Lake City, Utah
Site 43
San Antonio, Texas
Site 62
San Antonio, Texas
Site 80
San Antonio, Texas
Site 21
San Diego, California
Site 37
San Diego, California
Site 78
San Diego, California
Site 82
San Diego, California
Site 22
Savannah, Georgia
Site 99
Savannah, Georgia
Site 4
Seattle, Washington
Site 16
Shreveport, Louisiana
Site 45
South Bend, Indiana
Site 79
Southport, Connecticut
Site 107
Spring Hill, Florida
Site 2
St Louis, Missouri
Site 67
St Louis, Missouri
Site 52
Tacoma, Washington
Site 100
Tampa, Florida
Site 7
Texarkana, Texas
Site 34
Tucson, Arizona
Site 68
Tucson, Arizona
Site 18
Waterbury, Connecticut
Site 8
Waterloo, Iowa
Site 97
West Hartford, Connecticut
Site 77
West Palm Beach, Florida
Site 38
Winston-Salem, North Carolina
Site 70
Winston-Salem, North Carolina
Site 85
Winston-Salem, North Carolina
About this study
Official title: Efficacy Study Comparing 0.9 g and 1.25 g EstroGel® 0.03% Doses With Placebo in the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Associated With Menopause
This study is intended to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause.
Read the detailed description
The primary objective of this study was to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause by comparing the efficacy of 0.9 g and 1.25 g EstroGel® 0.03% doses with placebo. Effects on symptoms of vulvar and vaginal atrophy were assessed as secondary efficacy parameters.
- Conditions
- Postmenopausal Symptoms
- Being tested
- Estrogel, Placebo
- Keywords
- Post menopausal vasomotor symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstrogelDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| EstroGel® Gel 0.9 grams 0.03% | Experimental | 0.9 g of EstroGel® 0.03% applied to one arm and 1.25 g of placebo gel applied on the other arm once daily for 12 weeks. Receives: Drug: Estrogel |
| EstroGel® Gel 1.25 grams 0.03% | Experimental | 1.25 g of EstroGel® 0.03% applied to one arm and 0.9 g of placebo gel applied on the other arm once daily for 12 weeks. Receives: Drug: Estrogel |
| Placebo Gel | Placebo comparator | 0.9 g of placebo gel applied to one arm and 1.25 g of placebo gel applied on the other arm once daily for 12 weeks. Receives: Other: Placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study start2 Dec 2004
- Primary completion6 Sep 2005
- Study completion6 Sep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal SymptomsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASCEND Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Solvay Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00160173
- Sponsor's protocol ID
- S166.4.003
- Status last verified
- Sep 2022
- First submitted
- 8 Sep 2005
- Last updated
- 13 Sep 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study Comparing 0.9 g and 1.25 g EstroGel® 0.03% Doses With Placebo in the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Associated With Menopause
- ClinicalTrials.gov ID
- NCT00160173
- Acronym / sponsor ID
- S166.4.003
- Conditions
- Postmenopausal Symptoms
- Keywords
- Post menopausal vasomotor symptoms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- ASCEND TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Solvay Pharmaceuticals
- Study start
- 2 Dec 2004 (actual)
- Primary completion
- 6 Sep 2005 (actual)
- Study completion
- 6 Sep 2005 (actual)
- First posted
- 12 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.
This study is intended to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause.
Detailed description
The primary objective of this study was to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause by comparing the efficacy of 0.9 g and 1.25 g EstroGel® 0.03% doses with placebo. Effects on symptoms of vulvar and vaginal atrophy were assessed as secondary efficacy parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EstroGel® Gel 0.9 grams 0.03% | Experimental | Drug: Estrogel0.9 g of EstroGel® 0.03% applied to one arm and 1.25 g of placebo gel applied on the other arm once daily for 12 weeks. |
| EstroGel® Gel 1.25 grams 0.03% | Experimental | Drug: Estrogel1.25 g of EstroGel® 0.03% applied to one arm and 0.9 g of placebo gel applied on the other arm once daily for 12 weeks. |
| Placebo Gel | Placebo comparator | Other: Placebo0.9 g of placebo gel applied to one arm and 1.25 g of placebo gel applied on the other arm once daily for 12 weeks. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women 45-65 years
- naturally or surgically postmenopausal
- experiencing hot flushes
Key exclusion criteria (4 listed)
- hypersensitivity to estrogen replacement therapy
- pregnancy or lactating
- abnormal PAP smear
- history/suspected cervical, uterine, adrenal, pituitary, breast or ovarian malignancy
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 |
|---|---|---|
| Estrogel | Drug | EstroGel® Gel 0.9 grams 0.03%, EstroGel® Gel 1.25 grams 0.03% |
| Placebo | Other | Placebo Gel |
Primary outcome
Not reported in the source record.
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 13 Sep 2022.
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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.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
109 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 Estrogel in people with Postmenopausal Symptoms, run by ASCEND Therapeutics at 109 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 3 inclusion and 4 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 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 109 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.
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 13 Sep 2022.