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Hormone Replacement Therapy for Use in Postmenopausal Women for Relief of Hot Flushes and Urogenital Symptoms.

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ClinicalTrials.gov Identifier: NCT01070979
Recruitment Status : Completed
First Posted : February 18, 2010
Results First Posted : April 8, 2011
Last Update Posted : April 22, 2013
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hormone Replacement Therapy
Interventions Drug: Estradiol acetate
Drug: Estradiol
Drug: Conjugated equine estrogens
Enrollment 249
Recruitment Details Enrollment of postmenopausal women for relief of hot flushes and urogenital symptoms beginning Feb '03 at 33 sites in the US.
Pre-assignment Details Discontinue estrogen/hormone therapy prior to enrollment
Arm/Group Title Estradiol Acetate (E3A) Estradiol Conjugated Equine Estrogens (CEE)
Hide Arm/Group Description 1 tablet daily containing 0.9 mg estradiol acetate 1 tablet daily containing 1 mg estradiol 1 tablet daily containing 0.625 mg conjugated equine estrogen
Period Title: Overall Study
Started 79 85 85
Completed 68 73 72
Not Completed 11 12 13
Reason Not Completed
Adverse Event             2             3             3
Lost to Follow-up             2             1             1
Protocol Violation             0             2             6
Surgery, moving, personal, abn. labs             4             4             2
Withdrawal by Subject             3             1             1
No study drug taken             0             1             0
Arm/Group Title Estradiol Acetate (E3A) Estradiol Conjugated Equine Estrogens (CEE) Total
Hide Arm/Group Description 1 tablet daily containing 0.9 mg estradiol acetate 1 tablet daily containing 1 mg estradiol 1 tablet daily containing 0.625 mg conjugated equine estrogen Total of all reporting groups
Overall Number of Baseline Participants 79 85 85 249
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 79 participants 85 participants 85 participants 249 participants
52.2  (6.6) 52.3  (7.0) 53.8  (6.3) 52.8  (6.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 85 participants 85 participants 249 participants
Female
79
 100.0%
85
 100.0%
85
 100.0%
249
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 79 participants 85 participants 85 participants 249 participants
79 85 85 249
1.Primary Outcome
Title Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 4, ITT (Intention to Treat) Population
Hide Description 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
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)
Arm/Group Title Estradiol Acetate (E3A) Estradiol Conjugated Equine Estrogens (CEE)
Hide Arm/Group Description:
1 tablet daily containing 0.9 mg estradiol acetate
1 tablet daily containing 1 mg estradiol
1 tablet daily containing 0.625 mg conjugated equine estrogen
Overall Number of Participants Analyzed 77 80 84
Least Squares Mean (Standard Error)
Unit of Measure: Change in Hot Flush Count
-54.1  (4.5) -62.0  (4.5) -54.5  (4.3)
2.Primary Outcome
Title Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 12, ITT Population
Hide Description 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
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)
Arm/Group Title Estradiol Acetate (E3A) Estradiol Conjugated Equine Estrogens (CEE)
Hide Arm/Group Description:
1 tablet daily containing 0.9 mg estradiol acetate
1 tablet daily containing 1 mg estradiol
1 tablet daily containing 0.625 mg conjugated equine estrogen
Overall Number of Participants Analyzed 77 80 84
Least Squares Mean (Standard Error)
Unit of Measure: Change in Hot Flush Count
-63.6  (4.8) -72.2  (4.7) -67.2  (4.6)
3.Secondary Outcome
Title Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 4, ITT Population
Hide Description 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.
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)
Arm/Group Title Estradiol Acetate (E3A) Estradiol Conjugated Equine Estrogens (CEE)
Hide Arm/Group Description:
1 tablet daily containing 0.9 mg estradiol acetate
1 tablet daily containing 1 mg estradiol
1 tablet daily containing 0.625 mg conjugated equine estrogen
Overall Number of Participants Analyzed 77 80 84
Least Squares Mean (Standard Error)
Unit of Measure: Change in Score
-0.53  (0.106) -0.51  (0.106) -0.59  (0.102)
4.Secondary Outcome
Title Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 12, ITT Population
Hide Description 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.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)
Arm/Group Title Estradiol Acetate (E3A) Estradiol Conjugated Equine Estrogens (CEE)
Hide Arm/Group Description:
1 tablet daily containing 0.9 mg estradiol acetate
1 tablet daily containing 1 mg estradiol
1 tablet daily containing 0.625 mg conjugated equine estrogen
Overall Number of Participants Analyzed 77 80 84
Least Squares Mean (Standard Error)
Unit of Measure: Change in Score
-1.05  (0.127) -1.34  (0.125) -1.17  (0.122)
5.Secondary Outcome
Title Mean Change From Baseline in Total Urogenital Symptom Score, Week 4, ITT Population
Hide Description Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)
Arm/Group Title Estradiol Acetate (E3A) Estradiol Conjugated Equine Estrogens (CEE)
Hide Arm/Group Description:
1 tablet daily containing 0.9 mg estradiol acetate
1 tablet daily containing 1 mg estradiol
1 tablet daily containing 0.625 mg conjugated equine estrogen
Overall Number of Participants Analyzed 77 80 84
Least Squares Mean (Standard Error)
Unit of Measure: Change in Score
-1.89  (0.413) -2.26  (0.407) -1.96  (0.398)
6.Secondary Outcome
Title Change From Baseline in Total Urogenital Symptom Score, Week 8, ITT Population
Hide Description Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)
Arm/Group Title Estradiol Acetate (E3A) Estradiol Conjugated Equine Estrogens (CEE)
Hide Arm/Group Description:
1 tablet daily containing 0.9 mg estradiol acetate
1 tablet daily containing 1 mg estradiol
1 tablet daily containing 0.625 mg conjugated equine estrogen
Overall Number of Participants Analyzed 77 80 84
Least Squares Mean (Standard Error)
Unit of Measure: Change in Score
-1.96  (0.432) -2.58  (0.425) -2.42  (0.416)
7.Secondary Outcome
Title Change From Baseline in Total Urogenital Symptom Score, Week 12, ITT Population
Hide Description Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)
Arm/Group Title Estradiol Acetate (E3A) Estradiol Conjugated Equine Estrogens (CEE)
Hide Arm/Group Description:
1 tablet daily containing 0.9 mg estradiol acetate
1 tablet daily containing 1 mg estradiol
1 tablet daily containing 0.625 mg conjugated equine estrogen
Overall Number of Participants Analyzed 77 80 84
Least Squares Mean (Standard Error)
Unit of Measure: Change in Score
-2.49  (0.437) -2.59  (0.431) -2.52  (0.422)
Time Frame 7 months
Adverse Event Reporting Description February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
 
Arm/Group Title Estradiol Acetate (E3A) Estradiol Conjugated Equine Estrogens (CEE)
Hide Arm/Group Description 1 tablet daily containing 0.9 mg estradiol acetate 1 tablet daily containing 1 mg estradiol 1 tablet daily containing 0.625 mg conjugated equine estrogen
All-Cause Mortality
Estradiol Acetate (E3A) Estradiol Conjugated Equine Estrogens (CEE)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Estradiol Acetate (E3A) Estradiol Conjugated Equine Estrogens (CEE)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/79 (0.00%)      1/84 (1.19%)      0/85 (0.00%)    
Reproductive system and breast disorders       
metrorrhagia  1  0/79 (0.00%)  0 1/84 (1.19%)  1 0/85 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (6.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Estradiol Acetate (E3A) Estradiol Conjugated Equine Estrogens (CEE)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/79 (24.05%)      25/84 (29.76%)      30/85 (35.29%)    
Gastrointestinal disorders       
Nausea  1  4/79 (5.06%)  1/84 (1.19%)  2/85 (2.35%) 
Abdominal Distention  1  1/79 (1.27%)  4/84 (4.76%)  2/85 (2.35%) 
Infections and infestations       
Vaginosis Fungal  1  0/79 (0.00%)  1/84 (1.19%)  3/85 (3.53%) 
Investigations       
Weight Increased  1  1/79 (1.27%)  1/84 (1.19%)  3/85 (3.53%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  2/79 (2.53%)  2/84 (2.38%)  3/85 (3.53%) 
Nervous system disorders       
Headache  1  3/79 (3.80%)  5/84 (5.95%)  6/85 (7.06%) 
Nasopharyngitis  1  1/79 (1.27%)  3/84 (3.57%)  0/85 (0.00%) 
Psychiatric disorders       
Anxiety  1  3/79 (3.80%)  0/84 (0.00%)  2/85 (2.35%) 
Reproductive system and breast disorders       
Breast Tenderness  1  2/79 (2.53%)  5/84 (5.95%)  5/85 (5.88%) 
Metrorrhagia  1  2/79 (2.53%)  3/84 (3.57%)  4/85 (4.71%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (6.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Grexan Wulff, Manager Regulatory Affairs
Organization: Warner Chilcott
Phone: 973-442-3376
EMail: gwulff@wcrx.com
Layout table for additonal information
Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT01070979    
Other Study ID Numbers: PR-03602.1
First Submitted: February 17, 2010
First Posted: February 18, 2010
Results First Submitted: February 14, 2011
Results First Posted: April 8, 2011
Last Update Posted: April 22, 2013