Hot Flushes, Menopause, PostmenopausePhase 2NCT00160342
Comparison of Estrogen and Methyltestosterone Combination Treatments for Postmenopausal Hot Flushes
A Phase 2 study testing Esterified Estrogens (EE) and Methyltestosterone (MT) in people with Hot Flushes, Menopause, Postmenopause, run by Solvay Pharmaceuticals at 125 sites in 3 countries.
Trial summary
This is a research study to evaluate the effectiveness, safety and side effects of several dose levels of esterified estrogens (EE) and methyltestosterone (MT) given individually and in combination compared to a placebo (a tablet with no active drug in it) as a possible treatment for vasomotor symptoms (such as hot… Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Hot Flushes, Menopause, Postmenopause
- What is being tested?
- Esterified Estrogens (EE) and Methyltestosterone (MT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,251 participants
- Where
- 125 sitesin 3 countries
- Study dates
- Jun 2005to Sep 2007
- 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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able to communicate with the Investigator and study staff and be able to complete the required study procedures,
- Be a female of any race between the ages of 45-65 years, in generally good health,
- Be either naturally or surgically postmenopausal (with or without a uterus)
Who cannot join
- Known sensitivity or contraindications to natural or synthetic estrogens, androgens or progestins,
- History of or current diagnosis of malignant melanoma, breast cancer or any cancer (except non-melanomatous skin cancer) diagnosed less than 5 years prior to beginning the study
Trial locations and contacts
125 sites in 3 countries.
125 sites in 3 countries
United States88 sites
Site 40
Alpharetta, Georgia
Site 90
Alpharetta, Georgia
Site 43
Ann Arbor, Michigan
Site 23
Atlanta, Georgia
Site 8
Atlanta, Georgia
Site 25
Aventura, Florida
Site 26
Aventura, Florida
Site 52
Baton Rouge, Louisiana
Site 17
Billings, Montana
Site 76
Boise, Idaho
Site 86
Bryan, Texas
Site 70
Carmichael, California
Site 85
Carmichael, California
Site 64
Champaign, Illinois
Site 47
Charlottesville, Virginia
Site 12
Chaska, Minnesota
Site 10
Chattanooga, Tennessee
Site 80
Chesterfield, Missouri
Site 58
Chicago, Illinois
Site 72
Chicago, Illinois
Site 74
Chicago, Illinois
Site 45
Cincinnati, Ohio
Site 81
Cincinnati, Ohio
Site 51
Clearwater, Florida
Site 71
Clearwater, Florida
Site 53
Columbus, Ohio
Site 20
Corpus Christi, Texas
Site 61
Daytona Beach, Florida
Site 66
Denver, Colorado
Site 50
Evansville, Indiana
Site 75
Gainesville, Florida
Site 24
Greenville, South Carolina
Site 4
Groton, Connecticut
Site 67
Hilton Head, South Carolina
Site 11
Houston, Texas
Site 6
Jonesboro, Arkansas
Site 16
Kansas City, Missouri
Site 19
Kansas City, Missouri
Site 7
Las Vegas, Nevada
Site 36
Lincoln, Nebraska
Site 62
Little Rock, Arkansas
Site 15
Lutherville, Maryland
Site 65
Mandeville, Louisiana
Site 34
Mayfield Heights, Ohio
Site 88
Memphis, Tennessee
Site 73
Metarie, Louisiana
Site 78
Mogadore, Ohio
Site 37
Montgomery, Alabama
Site 69
Montgomery, Alabama
Site 56
Nashville, Tennessee
Site 39
New Bern, North Carolina
Site 35
New Britain, Connecticut
Site 2
Norfolk, Virginia
Site 87
Northridge, California
Site 33
Pensacola, Florida
Site 84
Philadelphia, Pennsylvania
Site 13
Portland, Oregon
Site 89
Portland, Oregon
Site 63
Pottstown, Pennsylvania
Site 60
Powder Springs, Georgia
Site 79
Raleigh, North Carolina
Site 28
Reno, Nevada
Site 29
Richmond, Virginia
Site 48
Richmond, Virginia
Site 49
Salt Lake City, Utah
Site 30
San Antonio, Texas
Site 41
San Antonio, Texas
Site 18
San Diego, California
Site 27
San Diego, California
Site 54
San Diego, California
Site 55
Savannah, Georgia
Site 5
Seattle, Washington
Site 38
Spokane, Washington
Site 3
St Louis, Missouri
Site 21
Stuart, Florida
Site 32
Tacoma, Washington
Site 82
Tampa, Florida
Site 44
Tucson, Arizona
Site 77
Tulsa, Oklahoma
Site 9
Venice, Florida
Site 42
Virginia Beach, Virginia
Site 31
Vista, California
Site 68
Walnut Creek, California
Site 22
Warwick, Rhode Island
Site 14
Waterbury, Connecticut
Site 83
West Palm Beach, Florida
Site 46
Winston-Salem, North Carolina
Site 59
Winston-Salem, North Carolina
Canada25 sites
Site 120
Abbotsford British Columbia, British Columbia
Site 109
Burlington, Ontario
Site 114
Corunna, Ontario
Site 95
Hamilton, Ontario
Site 115
Kingston, Ontario
Site 107
London, Ontario
Site 112
Montreal, Quebec
Site 106
Newmarket, Ontario
Site 100
North Vancouver, British Columbia
Site 137
Ottawa, Ontario
Site 117
Peterborough, Ontario
Site 103
Rimouski, Quebec
Site 119
Sainte-Foy, Quebec
Site 94
Sainte-Foy, Quebec
Site 113
Sarnia, Ontario
Site 92
Sarnia, Ontario
Site 91
Shawinigan, Quebec
Site 105
Sherbrooke, Quebec
Site 136
Sherbrooke, Quebec
Site 111
St. John's, Newfoundland and Labrador
Site 96
Strathroy, Ontario
Site 135
Victoria, British Columbia
Site 116
West Vancouver, British Columbia
Site 122
Winnipeg, Manitoba
Site 93
Winnipeg, Manitoba
Russia12 sites
Site 124
Moscow
Site 125
Moscow
Site 126
Moscow
Site 128
Moscow
Site 129
Moscow
Site 130
Moscow
Site 132
Moscow
Site 133
Moscow
Site 127
Saint Petersburg
Site 131
Saint Petersburg
Site 134
Saint Petersburg
Site 138
Saint Petersburg
About this study
Official title: A Multi-Center, Double-Blind, Placebo-Controlled Comparison of Multiple Doses of Esterified Estrogens and Methyltestosterone, in Combination and Alone, in Relieving Vasomotor Symptoms in Postmenopausal Women
This is a research study to evaluate the effectiveness, safety and side effects of several dose levels of esterified estrogens (EE) and methyltestosterone (MT) given individually and in combination compared to a placebo (a tablet with no active drug in it) as a possible treatment for vasomotor symptoms (such as hot flushes and flushing) of menopause. EE and testosterone are two hormones which are typically deficient in menopausal women
- Conditions
- Hot Flushes, Menopause, Postmenopause
- Being tested
- Esterified Estrogens (EE) and Methyltestosterone (MT)
- Keywords
- Hormone replacement therapy, hot flushes, postmenopause
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esterified Estrogens (EE) and Methyltestosterone (MT)Drug
oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT
Esterified Estrogens (EE) and Methyltestosterone (MT)Drug
oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT
Esterified Estrogens (EE) and Methyltestosterone (MT)Drug
oral tablet, QD, 12 weeks, 0.15 EE/0.30 MT
Esterified Estrogens (EE) and Methyltestosterone (MT)Drug
oral tablet, QD, 12 weeks, 0.30 EE/0.30 MT
Esterified Estrogens (EE) and Methyltestosterone (MT)Drug
oral tablet, QD, 12 weeks, 0.30 EE
Esterified Estrogens (EE) and Methyltestosterone (MT)Drug
oral tablet, QD, 12 weeks, 0.30 EE/0.60 MT
Esterified Estrogens (EE) and Methyltestosterone (MT)Drug
oral tablet, QD, 12 weeks, 0.45 EE
Esterified Estrogens (EE) and Methyltestosterone (MT)Drug
oral tablet, QD, 12 weeks, 0.60 MT
Esterified Estrogens (EE) and Methyltestosterone (MT)Drug
oral tablet, QD, 12 weeks, Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) |
| 2 | Experimental | Not described Receives: Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) |
| 3 | Experimental | Not described Receives: Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) |
| 4 | Active comparator | Not described Receives: Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) |
| 5 | Experimental | Not described Receives: Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) |
| 6 | Experimental | Not described Receives: Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) |
| 7 | Active comparator | Not described Receives: Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) |
| 8 | Active comparator | Not described Receives: Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) |
| 9 | Placebo comparator | Not described Receives: Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in frequency of moderate to severe vasomotor symptoms (VMS) from baseline to Week 4
Measured: 4 weeks
Mean change in frequency of moderate to severe VMS from baseline to Week 12
Measured: 12 weeks
Mean change in severity of moderate to severe VMS from baseline to Week 4
Measured: 4 weeks
Mean change in severity of moderate to severe VMS from baseline to Week 12
Measured: 12 weeks
Secondary outcomes (4)
Frequency and severity of moderate to severe and all hot flushes at each week
Measured: 12 weeks
Mean change from baseline to Week 12 in the moderate to severe vulvar and vaginal atrophy symptom identified by the subject as most bothersome
Measured: 12 weeks
Mean change from baseline to Week 12 in vaginal pH
Measured: 12 weeks
Mean change from baseline to Week 12 in vaginal maturation index (parabasal and superficial cells)
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 posted12 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot Flushes, Menopause, PostmenopauseStudies 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
- 1,251 participants (estimated)
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
- NCT00160342
- Sponsor's protocol ID
- S030.2.112
- Other IDs
- 2005-002887-27, 2005
- Status last verified
- Aug 2008
- First submitted
- 9 Sep 2005
- Last updated
- 15 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Blind, Placebo-Controlled Comparison of Multiple Doses of Esterified Estrogens and Methyltestosterone, in Combination and Alone, in Relieving Vasomotor Symptoms in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00160342
- Acronym / sponsor ID
- S030.2.112
- Conditions
- Hot Flushes, Menopause, Postmenopause
- Keywords
- Hormone replacement therapy, hot flushes, postmenopause
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,251 participants (estimated)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (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 is a research study to evaluate the effectiveness, safety and side effects of several dose levels of esterified estrogens (EE) and methyltestosterone (MT) given individually and in combination compared to a placebo (a tablet with no active drug in it) as a possible treatment for vasomotor symptoms (such as hot flushes and flushing) of menopause. EE and testosterone are two hormones which are typically deficient in menopausal women
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) |
| 2 | Experimental | Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) |
| 3 | Experimental | Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) |
| 4 | Active comparator | Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) |
| 5 | Experimental | Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) |
| 6 | Experimental | Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) |
| 7 | Active comparator | Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) |
| 8 | Active comparator | Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) |
| 9 | Placebo comparator | Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) |
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)
- Be able to communicate with the Investigator and study staff and be able to complete the required study procedures,
- Be a female of any race between the ages of 45-65 years, in generally good health,
- Be either naturally or surgically postmenopausal (with or without a uterus)
Key exclusion criteria (2 listed)
- Known sensitivity or contraindications to natural or synthetic estrogens, androgens or progestins,
- History of or current diagnosis of malignant melanoma, breast cancer or any cancer (except non-melanomatous skin cancer) diagnosed less than 5 years prior to beginning the study
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 (EE) and Methyltestosterone (MT)oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT | Drug | 1 |
| Esterified Estrogens (EE) and Methyltestosterone (MT)oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT | Drug | 2 |
| Esterified Estrogens (EE) and Methyltestosterone (MT)oral tablet, QD, 12 weeks, 0.15 EE/0.30 MT | Drug | 3 |
| Esterified Estrogens (EE) and Methyltestosterone (MT)oral tablet, QD, 12 weeks, 0.30 EE/0.30 MT | Drug | 5 |
| Esterified Estrogens (EE) and Methyltestosterone (MT)oral tablet, QD, 12 weeks, 0.30 EE | Drug | 4 |
| Esterified Estrogens (EE) and Methyltestosterone (MT)oral tablet, QD, 12 weeks, 0.30 EE/0.60 MT | Drug | 6 |
| Esterified Estrogens (EE) and Methyltestosterone (MT)oral tablet, QD, 12 weeks, 0.45 EE | Drug | 7 |
| Esterified Estrogens (EE) and Methyltestosterone (MT)oral tablet, QD, 12 weeks, 0.60 MT | Drug | 8 |
| Esterified Estrogens (EE) and Methyltestosterone (MT)oral tablet, QD, 12 weeks, Placebo | Drug | 9 |
Primary outcome
Mean change in frequency of moderate to severe vasomotor symptoms (VMS) from baseline to Week 4
Time frame: 4 weeks
Mean change in frequency of moderate to severe VMS from baseline to Week 12
Time frame: 12 weeks
Mean change in severity of moderate to severe VMS from baseline to Week 4
Time frame: 4 weeks
Mean change in severity of moderate to severe VMS from baseline to Week 12
Time frame: 12 weeks
4 secondary outcomes
Frequency and severity of moderate to severe and all hot flushes at each week
Time frame: 12 weeks
Mean change from baseline to Week 12 in the moderate to severe vulvar and vaginal atrophy symptom identified by the subject as most bothersome
Time frame: 12 weeks
Mean change from baseline to Week 12 in vaginal pH
Time frame: 12 weeks
Mean change from baseline to Week 12 in vaginal maturation index (parabasal and superficial cells)
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 15 Aug 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
125 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Esterified Estrogens (EE) and Methyltestosterone (MT) in people with Hot Flushes, Menopause, Postmenopause, run by Solvay Pharmaceuticals at 125 sites in 3 countries.
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 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 15 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 125 sites in United States, Canada, Russia. 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 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 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?
Mean change in frequency of moderate to severe vasomotor symptoms (VMS) from baseline to Week 4 (time frame: 4 weeks). The study lists 4 primary outcomes in all. 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 15 Aug 2008.