MenopausePhase 2NCT00141557
The Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women
A Phase 2 study testing esterified estrogens 1.25mg and methyltestosterone 2.5mg and Esterified estrogens 1.25 mg in people with Menopause, run by Solvay Pharmaceuticals at 78 sites in United States.
Trial summary
To determine whether treatment with ESTRATEST® Tablets is superior to treatment with esterified estrogens tablets Read more about this study
- Who is it for?
- Ages 35 to 65 years, women only
- Conditions the study is for
- Menopause
- What is being tested?
- esterified estrogens 1.25mg and methyltestosterone 2.5mg and Esterified estrogens 1.25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 78 sitesUnited States
- Study dates
- Jul 2004to Mar 2008
- Phase
- Phase 2
- 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 35 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hysterectomized, menopausal women between the ages of 30 and 65 years of age (inclusive) with symptoms of estrogen and/or androgen deficiency not currently controlled by estrogen therapy as determined by patient report and the Investigator's clinical judgement
Who cannot join
None listed.
Trial locations and contacts
78 sites in 1 country.
78 sites in 1 country
United States78 sites
Site 50
Alpharetta, Georgia
Site 31
Anderson, South Carolina
Site 53
Ann Arbor, Michigan
Site 5
Atlanta, Georgia
Site 10
Aventura, Florida
Site 59
Baton Rouge, Louisiana
Site 72
Billings, Montana
Site 47
Boise, Idaho
Site 68
Carmichael, California
Site 65
Cary, North Carolina
Site 24
Champaign, Illinois
Site 4
Chattanooga, Tennessee
Site 20
Chicago, Illinois
Site 78
Clearwater, Florida
Site 60
Columbus, Ohio
Site 74
Conroe, Texas
Site 8
Corpus Christi, Texas
Site 71
Dallas, Texas
Site 44
Decatur, Georgia
Site 26
Denver, Colorado
Site 77
Douglasville, Georgia
Site 55
Encinitas, California
Site 18
Erie, Pennsylvania
Site 62
Eugene, Oregon
Site 58
Evansville, Indiana
Site 73
Fort Myers, Florida
Site 35
Greer, South Carolina
Site 1
Groton, Connecticut
Site 54
Hartford, Connecticut
Site 42
Houston, Texas
Site 66
Huntsville, Alabama
Site 3
Jonesboro, Arkansas
Site 63
Kansas City, Missouri
Site 51
Leesburg, Florida
Site 21
Lincoln, Nebraska
Site 22
Little Rock, Arkansas
Site 41
Medford, Oregon
Site 49
Melbourne, Florida
Site 57
Mobile, Alabama
Site 46
Montgomery, Alabama
Site 13
New Bern, North Carolina
Site 52
New Orleans, Louisiana
Site 64
New Port Richey, Florida
Site 28
Norfolk, Virginia
Site 61
Ocala, Florida
Site 67
Oklahoma City, Oklahoma
Site 27
Palm Springs, Florida
Site 76
Peoria, Illinois
Site 19
Philadelphia, Pennsylvania
Site 29
Phoenix, Arizona
Site 11
Pinellas Park, Florida
Site 33
Portland, Oregon
Site 23
Pottstown, Pennsylvania
Site 37
Reno, Nevada
Site 56
Renton, Washington
Site 12
Richmond, Virginia
Site 32
Richmond Heights, Missouri
Site 9
Riverdale, Georgia
Site 38
Salt Lake City, Utah
Site 14
San Antonio, Texas
Site 6
San Diego, California
Site 45
Santa Rosa, California
Site 75
Sarasota, Florida
Site 7
Savannah, Georgia
Site 2
Seattle, Washington
Site 48
Spokane, Washington
Site 36
St Louis, Missouri
Site 69
St. Petersburg, Florida
Site 43
Tacoma, Washington
Site 30
Trumbull, Connecticut
Site 15
Tucson, Arizona
Site 40
Tulsa, Oklahoma
Site 70
Venice, Florida
Site 25
Walnut Creek, California
Site 34
Waterbury, Connecticut
Site 17
West Palm Beach, Florida
Site 39
Wichita, Kansas
Site 16
Winston-Salem, North Carolina
About this study
Official title: A Multi-Center, Double-Blind Study to Determine the Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women
To determine whether treatment with ESTRATEST® Tablets is superior to treatment with esterified estrogens tablets
- Conditions
- Menopause
- Being tested
- esterified estrogens 1.25mg and methyltestosterone 2.5mg, Esterified estrogens 1.25 mg
- Keywords
- Menopause; Postmenopause; Estrogen; Hormone Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esterified estrogens 1.25mg and methyltestosterone 2.5mgDrug
ESTRATEST® administered orally QD
Esterified estrogens 1.25 mgDrug
Esterified estrogens 1.25 mg administered orally QD
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: esterified estrogens 1.25mg and methyltestosterone 2.5mg |
| 2 | Active comparator | Not described Receives: Drug: Esterified estrogens 1.25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the total score of the Menopause Rating Scale (MRS)
Measured: 12 weeks
Secondary outcomes (3)
Change from baseline in the domain and individual item scores of the MRS
Measured: 12 weeks
Change from baseline in the domain scores of the MENQOL
Measured: monthly for 3 months
Comparison of changes in hormone levels and correlation with changes in the MRS
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 posted1 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionApr 2007
- Study completionMar 2008
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141557
- Sponsor's protocol ID
- S030.2.110
- Status last verified
- Apr 2008
- First submitted
- 30 Aug 2005
- Last updated
- 11 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Blind Study to Determine the Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00141557
- Acronym / sponsor ID
- S030.2.110
- Conditions
- Menopause
- Keywords
- Menopause; Postmenopause; Estrogen; Hormone Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Apr 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 1 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 whether treatment with ESTRATEST® Tablets is superior to treatment with esterified estrogens tablets
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: esterified estrogens 1.25mg and methyltestosterone 2.5mg |
| 2 | Active comparator | Drug: Esterified estrogens 1.25 mg |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hysterectomized, menopausal women between the ages of 30 and 65 years of age (inclusive) with symptoms of estrogen and/or androgen deficiency not currently controlled by estrogen therapy as determined by patient report and the Investigator's clinical judgement
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| esterified estrogens 1.25mg and methyltestosterone 2.5mgESTRATEST® administered orally QD | Drug | 1 |
| Esterified estrogens 1.25 mgEsterified estrogens 1.25 mg administered orally QD | Drug | 2 |
Primary outcome
Change from baseline in the total score of the Menopause Rating Scale (MRS)
Time frame: 12 weeks
3 secondary outcomes
Change from baseline in the domain and individual item scores of the MRS
Time frame: 12 weeks
Change from baseline in the domain scores of the MENQOL
Time frame: monthly for 3 months
Comparison of changes in hormone levels and correlation with changes in the MRS
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 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.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
78 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing esterified estrogens 1.25mg and methyltestosterone 2.5mg and Esterified estrogens 1.25 mg in people with Menopause, run by Solvay Pharmaceuticals at 78 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 1 inclusion and 0 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: stopped early, as of the sponsor's last update on 11 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 78 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
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?
Change from baseline in the total score of the Menopause Rating Scale (MRS) (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 11 Apr 2008.