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Multicenter, double-blind, controlled, parallel group, randomized study to compare the clinical benefit of Estradiol acetate tablets, estradiol tablets and conjugated equine estrogen tablets, each administered orally, once daily, to postmenopausal women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Estradiol acetate (E3A) | Experimental |
| |
| Estradiol | Active Comparator |
| |
| Conjugated equine estrogens (CEE): | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estradiol acetate | Drug | Tablet containing 0.9 mg E3A, daily oral administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 4, ITT (Intention to Treat) Population | Severity of hot flush definitions: mild - sensation of heat without perspiration, moderate - sensation of heat with perspiration, able to continue activity, severe - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep | Baseline to Week 4 |
| Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 12, ITT Population | Severity of hot flush definitions: mild - sensation of heat without perspiration, moderate - sensation of heat with perspiration, able to continue activity, severe - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 4, ITT Population | Patient self-reported outcome. Severity of hot flush definitions: mild (1) - sensation of heat without perspiration, moderate (2) - sensation of heat with perspiration, able to continue activity, severe (3) - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep. Minimum 0/no hot flushes, Maximum 3/all severe hot flushes. Lower the score the greater the improvement in reducing hot flushes. |
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Inclusion Criteria:
Age ≥ 40 years of age; bilateral oophorectomy ≥ 35 years of age.
Non-hysterectomized women:
Hysterectomized women:
Seven or more moderate or severe hot flushes daily for 1 week or 60 or more moderate or severe flushes in 1 week during the 2 week screening period prior to study entry.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Herman Ellman, MD | Warner Chilcott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Warner Chilcott Investigational Site | Phoenix | Arizona | 85031 | United States | ||
| Warner Chilcott Investigational Site |
Discontinue estrogen/hormone therapy prior to enrollment
Enrollment of postmenopausal women for relief of hot flushes and urogenital symptoms beginning Feb '03 at 33 sites in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Estradiol Acetate (E3A) | 1 tablet daily containing 0.9 mg estradiol acetate |
| FG001 | Estradiol | 1 tablet daily containing 1 mg estradiol |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Estradiol | Drug | Tablet containing 1 mg estradiol, daily oral administration. |
|
|
| Conjugated equine estrogens | Drug | Tablet containing 0.625 mg CEE, daily oral administration. |
|
|
| Baseline to Week 4 |
| Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 12, ITT Population | Patient self-reported outcome. Severity of hot flush definitions: mild (1) - sensation of heat without perspiration, moderate (2) - sensation of heat with perspiration, able to continue activity, severe (3) - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep. Minimum 0/no hot flushes, Maximum 3/all severe hot flushes. Lower the score the greater the improvement in reducing hot flushes. | Baseline to Week 12 |
| Mean Change From Baseline in Total Urogenital Symptom Score, Week 4, ITT Population | Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3. | Baseline to Week 4 |
| Change From Baseline in Total Urogenital Symptom Score, Week 8, ITT Population | Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3. | Baseline to Week 8 |
| Change From Baseline in Total Urogenital Symptom Score, Week 12, ITT Population | Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3. | Baseline to Week 12 |
| Carmichael |
| California |
| 95608 |
| United States |
| Warner Chilcott Investigational Site | San Diego | California | 92108 | United States |
| Warner Chilcott Investigational Site | San Diego | California | 92123 | United States |
| Warner Chilcott Investigational Site | Aventura | Florida | 33180 | United States |
| Warner Chilcott Investigational Site | Boynton Beach | Florida | 33437 | United States |
| Warner Chilcott Investigational Site | Clearwater | Florida | 33765 | United States |
| Warner Chilcott Investigational Site | Daytona Beach | Florida | 32114 | United States |
| Warner Chilcott Investigational Site | Gainesville | Florida | 32605 | United States |
| Warner Chilcott Investigational Site | Longwood | Florida | 32779 | United States |
| Warner Chilcott Investigational Site | Melbourne | Florida | 32935 | United States |
| Warner Chilcott Investigational Site | Miami | Florida | 33143 | United States |
| Warner Chilcott Investigational Site | Palm Springs | Florida | 33461 | United States |
| Warner Chilcott Investigational Site | Pinellas Park | Florida | 33781 | United States |
| Warner Chilcott Investigational Site | Sarasota | Florida | 34232 | United States |
| Warner Chilcott Investigational Site | Venice | Florida | 34285 | United States |
| Warner Chilcott Investigational Site | Roswell | Georgia | 30075 | United States |
| Warner Chilcott Investigational Site | Chicago | Illinois | 60612 | United States |
| Warner Chilcott Investigational Site | Peoria | Illinois | 61615 | United States |
| Warner Chilcott Investigational Site | Laurel | Maryland | 20707 | United States |
| Warner Chilcott Investigational Site | Lincoln | Nebraska | 68510 | United States |
| Warner Chilcott Investigational Site | Raleigh | North Carolina | 27612 | United States |
| Warner Chilcott Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Warner Chilcott Investigational Site | Cleveland | Ohio | 44122 | United States |
| Warner Chilcott Investigational Site | Columbus | Ohio | 43212 | United States |
| Warner Chilcott Investigational Site | Mogadore | Ohio | 44260 | United States |
| Warner Chilcott Investigational Site | Portland | Oregon | 97201 | United States |
| Warner Chilcott Investigational Site | Pittsburgh | Pennsylvania | 15206 | United States |
| Warner Chilcott Investigational Site | Nashville | Tennessee | 37203 | United States |
| Warner Chilcott Investigational Site | Salt Lake City | Utah | 84124 | United States |
| Warner Chilcott Investigational Site | Spokane | Washington | 99201 | United States |
| Warner Chilcott Investigational Site | Tacoma | Washington | 98405 | United States |
| FG002 | Conjugated Equine Estrogens (CEE) | 1 tablet daily containing 0.625 mg conjugated equine estrogen |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Estradiol Acetate (E3A) | 1 tablet daily containing 0.9 mg estradiol acetate |
| BG001 | Estradiol | 1 tablet daily containing 1 mg estradiol |
| BG002 | Conjugated Equine Estrogens (CEE) | 1 tablet daily containing 0.625 mg conjugated equine estrogen |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 4, ITT (Intention to Treat) Population | Severity of hot flush definitions: mild - sensation of heat without perspiration, moderate - sensation of heat with perspiration, able to continue activity, severe - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep | Intention to Treat (ITT) with Last Observation Carried Forward (LOCF) | Posted | Least Squares Mean | Standard Error | Change in Hot Flush Count | Baseline to Week 4 |
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| Secondary | Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 4, ITT Population | Patient self-reported outcome. Severity of hot flush definitions: mild (1) - sensation of heat without perspiration, moderate (2) - sensation of heat with perspiration, able to continue activity, severe (3) - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep. Minimum 0/no hot flushes, Maximum 3/all severe hot flushes. Lower the score the greater the improvement in reducing hot flushes. | Intention to Treat (ITT) with Last Observation Carried Forward (LOCF) | Posted | Least Squares Mean | Standard Error | Change in Score | Baseline to Week 4 |
| |||||||||||||||||||||||||||||||||
| Primary | Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 12, ITT Population | Severity of hot flush definitions: mild - sensation of heat without perspiration, moderate - sensation of heat with perspiration, able to continue activity, severe - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep | Intention to Treat (ITT) with Last Observation Carried Forward (LOCF) | Posted | Least Squares Mean | Standard Error | Change in Hot Flush Count | Baseline to Week 12 |
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| Secondary | Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 12, ITT Population | Patient self-reported outcome. Severity of hot flush definitions: mild (1) - sensation of heat without perspiration, moderate (2) - sensation of heat with perspiration, able to continue activity, severe (3) - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep. Minimum 0/no hot flushes, Maximum 3/all severe hot flushes. Lower the score the greater the improvement in reducing hot flushes. | Intention to Treat (ITT) with Last Observation Carried Forward (LOCF) | Posted | Least Squares Mean | Standard Error | Change in Score | Baseline to Week 12 |
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| Secondary | Mean Change From Baseline in Total Urogenital Symptom Score, Week 4, ITT Population | Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3. | Intention to Treat (ITT) with Last Observation Carried Forward (LOCF) | Posted | Least Squares Mean | Standard Error | Change in Score | Baseline to Week 4 |
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| Secondary | Change From Baseline in Total Urogenital Symptom Score, Week 8, ITT Population | Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3. | Intention to Treat (ITT) with Last Observation Carried Forward (LOCF) | Posted | Least Squares Mean | Standard Error | Change in Score | Baseline to Week 8 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Urogenital Symptom Score, Week 12, ITT Population | Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3. | Intention to Treat (ITT) with Last Observation Carried Forward (LOCF) | Posted | Least Squares Mean | Standard Error | Change in Score | Baseline to Week 12 |
|
|
7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Estradiol Acetate (E3A) | 1 tablet daily containing 0.9 mg estradiol acetate | 0 | 79 | 19 | 79 | ||
| EG001 | Estradiol | 1 tablet daily containing 1 mg estradiol | 1 | 84 | 25 | 84 | ||
| EG002 | Conjugated Equine Estrogens (CEE) | 1 tablet daily containing 0.625 mg conjugated equine estrogen | 0 | 85 | 30 | 85 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| metrorrhagia | Reproductive system and breast disorders | MedDRA (6.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast Tenderness | Reproductive system and breast disorders | MedDRA (6.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (6.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (6.0) | Systematic Assessment |
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| Metrorrhagia | Reproductive system and breast disorders | MedDRA (6.0) | Systematic Assessment |
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| Abdominal Distention | Gastrointestinal disorders | MedDRA (6.0) | Systematic Assessment |
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| Vaginosis Fungal | Infections and infestations | MedDRA (6.0) | Systematic Assessment |
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| Weight Increased | Investigations | MedDRA (6.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (6.0) | Systematic Assessment |
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| Nasopharyngitis | Nervous system disorders | MedDRA (6.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (6.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grexan Wulff, Manager Regulatory Affairs | Warner Chilcott | 973-442-3376 | gwulff@wcrx.com |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004966 | Estrogens, Conjugated (USP) |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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