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Treatment Of Hot Flashes/Flushes In Postmenopausal Women (WARM Study)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00604825
First Posted: January 30, 2008
Last Update Posted: October 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: September 6, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Menopausal and Female Climacteric States
Interventions: Drug: Other: Placebo
Drug: GSK232802
Drug: PREMARIN

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted from at 75 centers (2 in Spain, 3 each in Argentina, New Zealand and the United Kingdom, 4 in Italy, 5 in Australia, 6 in Sweden, 12 in Germany, and 37 in the United States) from 17-July-2007 to 23-July-2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 982 healthy postmenopausal participants with moderate to extremely severe vasomotor symptoms were screened (626 screen failures) and 356 were randomized.

Reporting Groups
  Description
Placebo Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
GSK232802 25 mg Eligible participants received GSK232802 25 milligram (mg) tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
GSK232802 75 mg Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
Premarin 0.3 mg Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.

Participant Flow:   Overall Study
    Placebo   GSK232802 25 mg   GSK232802 75 mg   Premarin 0.3 mg
STARTED   90   87   89   90 
COMPLETED   81   72   73   79 
NOT COMPLETED   9   15   16   11 
Adverse Event                2                6                7                4 
Lost to Follow-up                0                3                1                0 
Protocol Violation                0                1                0                0 
Withdrawal by Subject                4                3                5                5 
Lack of Efficacy                3                2                1                0 
Did not meet eligibility criteria                0                0                2                0 
Physician Decision                0                0                0                1 
Exclusion criterion met                0                0                0                1 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
GSK232802 25 mg Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
GSK232802 75 mg Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
Premarin 0.3 mg Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo   GSK232802 25 mg   GSK232802 75 mg   Premarin 0.3 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 90   87   89   90   356 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.2  (4.17)   54.9  (4.72)   54.2  (4.78)   54.0  (5.18)   54.6  (4.73) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      90 100.0%      87 100.0%      89 100.0%      90 100.0%      356 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      1   1.1%      0   0.0%      0   0.0%      1   1.1%      2   0.6% 
Asian      1   1.1%      0   0.0%      1   1.1%      0   0.0%      2   0.6% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      4   4.4%      9  10.3%      9  10.1%      9  10.0%      31   8.7% 
White      84  93.3%      78  89.7%      79  88.8%      79  87.8%      320  89.9% 
More than one race      0   0.0%      0   0.0%      0   0.0%      1   1.1%      1   0.3% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) and Number of Participants With Mild, Moderate and Severe AE   [ Time Frame: Up to 21 weeks ]

2.  Primary:   Change From Baseline in Vital Signs of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 12   [ Time Frame: Baseline (Week 0) and Week 12 ]

3.  Primary:   Change From Baseline in Vital Sign of Heart Rate at Week 12   [ Time Frame: Baseline (Week 0) and Week 12 ]

4.  Primary:   Change From Baseline in Thyroid Stimulating Hormone (TSH) at Week 12   [ Time Frame: Baseline (Week 0) and Week 12 ]

5.  Primary:   Change From Baseline in Thyroxine (T4) and Insulin at Week 12   [ Time Frame: Baseline (Week 0) and Week 12 ]

6.  Primary:   Change From Baseline in Fasting Lipid Profile at Week 12   [ Time Frame: Baseline (Week 0) and Week 12 ]

7.  Primary:   Change From Baseline in Bi-layer Endometrial Thickness Measured by Transvaginal Ultrasound (TVUS) or Saline Infusion Sonohysterography (SIS)   [ Time Frame: Baseline (Week 0) to Week 12 ]

8.  Primary:   Endometrial Biopsy Pathology   [ Time Frame: Baseline (Week 0) to Week 12 ]

9.  Primary:   Occurrence of Withdrawal Bleeding-duration of Spotting/Bleeding   [ Time Frame: Up to Follow-up (Day 112) ]

10.  Primary:   Occurrence of Withdrawal Bleeding-number of Days of Spotting, Number of Days of Bleeding, Number of Days of Spotting/Bleeding Combined   [ Time Frame: Up to Follow-up (Day 112) ]

11.  Primary:   Mean Change in Frequency of Vasomotor Symptoms (VMS) From Baseline at Week 12   [ Time Frame: Baseline (Week 0) and Week 12 ]

12.  Primary:   Mean Change in Severity of VMS From Baseline at Week 12   [ Time Frame: Baseline (Week 0) and Week 12 ]

13.  Primary:   Change From Baseline in Thrombotic Marker- Fibrinogen at Week 12   [ Time Frame: Baseline (Week 0) and Week 12 ]

14.  Primary:   Change From Baseline in Thrombotic Marker- Tissue Plasminogen Activator (tPA) Antigen at Week 12   [ Time Frame: Baseline (Week 0) and Week 12 ]

15.  Primary:   Change From Baseline and Week 12 in Inflammatory Marker- High Sensitivity C-reactive Protein (Hs-CRP) at Week 12   [ Time Frame: Baseline (Week 0) and Week 12 ]

16.  Primary:   Change From Baseline and Week 12 in Inflammatory Marker- Endothelin-1 at Week 12   [ Time Frame: Baseline (Week 0) and Week 12 ]

17.  Primary:   Change From Baseline and Week 12 in Hematology Parameter- Hematocrit at Week 12   [ Time Frame: Baseline (Week 0) and Week 12 ]

18.  Primary:   Change From Baseline in Hematology Parameter- Mean Corpuscle Hemoglobin (MCH) at Week 12   [ Time Frame: Baseline (Week 0) and Week 12 ]

19.  Primary:   Change From Baseline in Hematology Parameter- Mean Corpuscle Volume (MCV) at Week 12   [ Time Frame: Baseline (Week 0) and Week 12 ]

20.  Primary:   Change From Baseline in Hematology Parameter- Red Blood Cell (RBC) Count at Week 12   [ Time Frame: Baseline (Week 0) and Week 12 ]

21.  Primary:   Change From Baseline in Hematology Parameters- Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Week 12   [ Time Frame: Baseline (Week 0) and Week 12 ]

22.  Primary:   Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Segmented Neutrophils, Total Neutrophils and White Blood Cell (WBC) Count at Week 12   [ Time Frame: Baseline (Week 0) and Week 12 ]

23.  Primary:   Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein at Week 12   [ Time Frame: Baseline (Week 0) and Week 12 ]

24.  Primary:   Change From Baseline in Clinical Chemistry Parameters- Creatinine, Direct Bilirubin, Total Bilirubin and Uric Acid at Week 12   [ Time Frame: Baseline (Week 0) and Week 12 ]

25.  Primary:   Change From Baseline in Clinical Chemistry Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST) at Week 12   [ Time Frame: Baseline (Week 0) and Week 12 ]

26.  Primary:   Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (C02) Content, Chloride, Phosphorous, Inorganic, Potassium, Sodium and Urea at Week 12   [ Time Frame: Baseline (Week 0) and Week 12 ]

27.  Secondary:   Mean Change in Frequency of VMS From Baseline to Weeks 4 and 8   [ Time Frame: Baseline (Week 0) to Week 8 ]

28.  Secondary:   Mean Change in Severity of VMS From Baseline to Weeks 4 and 8   [ Time Frame: Baseline (Week 0) to Week 8 ]

29.  Secondary:   Number of Participants With VMS Percent Change From Baseline Responders With a Reduction in Frequency at Week 12 of at Least 50%, at Least 75%, and 100%   [ Time Frame: Baseline (Week 0) and Week 12 ]

30.  Secondary:   Number of Participants With VMS Percent Change From Baseline Responders With a Reduction in Severity at Week 12 of at Least 50%, at Least 75%, and 100%   [ Time Frame: Baseline (Week 0) and Week 12 ]

31.  Secondary:   Change in Menopause Quality of Life (MENQoL) Score From Baseline to Visits 6 (Week 4) and Visit 8 (Week 12)   [ Time Frame: Baseline (Week 0) to Week 12 ]

32.  Secondary:   Change in Medical Outcomes Study (MOS) Sleep Score From Baseline to Visits 6 (Week 4) and Visit 8 (Week 12)   [ Time Frame: Baseline (Week 0) to Week 12 ]

33.  Secondary:   Changes in Vulvar Vaginal Atrophy (VVA) Symptom Score From Baseline to Visit 8 (Week 12)   [ Time Frame: Baseline (Week 0) to Visit 8 (Week 12) ]

34.  Secondary:   Change in Brief Fatigue Inventory (BFI) Score From Visit 2 to Visit 7   [ Time Frame: Visit 2 (Day -21) to Visit 7 (Week 8) ]

35.  Secondary:   Change in the Centers for Epidemiologic Studies in Depression (CES-D) Score From Visit 2 to Visit 7   [ Time Frame: Visit 2 (Day -21) to Visit 7 (Week 8) ]

36.  Secondary:   Change in Work Productivity and Activity Impairment (WPAI) Score From Visit 2 to Visit 7   [ Time Frame: Visit 2 (Day -21) to Visit 7 (Week 8) ]

37.  Secondary:   Change From Visit 2 to Visit 8 in Vaginal pH   [ Time Frame: Visit 2 (Day -21) to Visit 8 (Week 12) ]

38.  Secondary:   Change From Visit 2 to Visit 8 in Percentage of Superficial Cells to Determine the Vaginal Maturation Index (VMI)   [ Time Frame: Visit 2 (Day -21) to Visit 8 (Week 12) ]

39.  Secondary:   Change From Baseline in Glucose at Week 12   [ Time Frame: Baseline (Week 0) and Week 12 ]

40.  Secondary:   Change From Baseline at Week 12 in Serum Hormone Levels- Estradiol   [ Time Frame: Baseline (Week 0) and Week 12 ]

41.  Secondary:   Change From Baseline at Week 12 in Serum Hormone Levels- Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH)   [ Time Frame: Baseline (Week 0) and Week 12 ]

42.  Secondary:   Change From Baseline at Week 12 in Serum Hormone Levels- Testosterone   [ Time Frame: Baseline (Week 0) and Week 12 ]

43.  Secondary:   Change From Baseline at Week 12 in Waist Circumference   [ Time Frame: Baseline (Week 0) and Week 12 ]

44.  Secondary:   Change From Baseline at Week 12 in Hip Circumference   [ Time Frame: Baseline (Week 0) and Week 12 ]

45.  Secondary:   Change From Baseline at Week 12 in Weight   [ Time Frame: Baseline (Week 0) and Week 12 ]

46.  Secondary:   Change From Baseline at Week 12 in Body Mass Index (BMI)   [ Time Frame: Baseline (Week 0) and Week 12 ]

47.  Secondary:   Change From Baseline at Week 12 in Abdomen Body Circumference, Abdomen Saggital Diameter and Thigh Circumference   [ Time Frame: Baseline (Week 0) and Week 12 ]

48.  Secondary:   Change From Baseline at Week 12 in Abdomen Visceral Adipose Tissue (AVAT), Abdomen Subcutaneous Adipose Tissue (ASAT), Thigh Subcutaneous Adipose Tissue (TSAT) and Thigh Intermuscular Adipose Tissue (TIAT)   [ Time Frame: Baseline (Week 0) and Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00604825     History of Changes
Other Study ID Numbers: 105106
First Submitted: January 17, 2008
First Posted: January 30, 2008
Results First Submitted: September 6, 2017
Results First Posted: October 3, 2017
Last Update Posted: October 3, 2017