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

NCT00604825 | Completed Phase 2 Results

• 1 other identifier: 105106
• Study Type: interventional
• Target: 356
• Locations: 9 countries
• Sites: 87

Brief Summary

The purpose of this study is to determine whether GSK232802 is safe and effective in reducing the frequency and severity of hot flashes associated with menopause.

Conditions

Menopausal and Female Climacteric States

Keywords

menopause; hormone therapy; hot flashes; vasomotor symptoms

Outcome Measures

Primary Outcomes (26)

• Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) and Number of Participants With Mild, Moderate and Severe AE

  AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. The severity of AEs was assessed by the investigator as mild, moderate or severe.

  Up to 21 weeks

• Change From Baseline in Vital Signs of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 12

  SBP and DBP were measured after the participant had rested for at least 5 minutes in a sitting or supine position. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline in SBP and DBP at Week 12 are presented.

  Baseline (Week 0) and Week 12

• Change From Baseline in Vital Sign of Heart Rate at Week 12

  Heart rate was measured after the participant had rested for at least 5 minutes in a sitting or supine position. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline in heart rate at Week 12 are presented.

  Baseline (Week 0) and Week 12

• Change From Baseline in Thyroid Stimulating Hormone (TSH) at Week 12

  Serum hormone markers included TSH. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline in TSH at Week 12 are presented.

  Baseline (Week 0) and Week 12

• Change From Baseline in Thyroxine (T4) and Insulin at Week 12

  Serum hormone markers included T4 and additional pharmacodynamics marker included insulin. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline in T4 and insulin at Week 12 are presented.

  Baseline (Week 0) and Week 12

• Change From Baseline in Fasting Lipid Profile at Week 12

  Fasting lipids included total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholestereol direct and triglycerides. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline in fasting lipid profile at Week 12 are presented.

  Baseline (Week 0) and Week 12

• Change From Baseline in Bi-layer Endometrial Thickness Measured by Transvaginal Ultrasound (TVUS) or Saline Infusion Sonohysterography (SIS)

  All participants with an intact uterus participating in this study underwent a TVUS at Baseline and at Week 12, to investigate the cause of any abnormal uterine bleeding during the study. In the event the TVUS was not well visualized or there were abnormal findings at either visit, or the bi-layer thickness exceeded 5 millimeter at Week 12, a SIS was conducted to visualize the anterior and posterior walls. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline and Week 12 in heart rate are presented.

  Baseline (Week 0) to Week 12

• Endometrial Biopsy Pathology

  Endometrial biopsies were conducted at Baseline and end-of-treatment (end-of-treatment values were defined as the last available post-Baseline values before treatment was stopped) for all study participants with an intact uterus. These procedures were performed by an experienced physician. Each biopsy was obtained after the TVUS was performed. Proliferative endometrium also meant hyperplasia without atypia (normal).

  Baseline (Week 0) to Week 12

• Occurrence of Withdrawal Bleeding-duration of Spotting/Bleeding

  After completion of the 12-week treatment period, participants with an intact uterus received a 14-day cycle of progestogen (10 mg medroxyprogesterone acetate \[MPA\]) to induce withdrawal bleeding. All participants were required to return to clinic for Follow-Up Visit. Participants were asked to record occurrence of bleeding/spotting each day, from the day MPA dosing began until Follow-up using the following criteria: None (no bleeding or spotting), Spotting: any vaginal flow requiring not more than one sanitary napkin or tampon per day (lightly stained and not soaked through) and Bleeding: any vaginal flow requiring more than one sanitary napkin or tampon per day. The following information was recorded in electronic case report form: start and stop date of MPA administration as well as dates of any spotting/bleeding. Duration of spotting or bleeding is presented.

  Up to Follow-up (Day 112)

• Occurrence of Withdrawal Bleeding-number of Days of Spotting, Number of Days of Bleeding, Number of Days of Spotting/Bleeding Combined

  After completion of the 12-week treatment period, participants with an intact uterus received a 14-day cycle of progestogen (10 mg MPA) to induce withdrawal bleeding. All participants were required to return to clinic for Follow-Up Visit. Participants were asked to record occurrence of bleeding/spotting each day, from the day MPA dosing began until Follow-up using the following criteria: None (no bleeding or spotting), Spotting: any vaginal flow requiring not more than one sanitary napkin or tampon per day (lightly stained and not soaked through) and Bleeding: any vaginal flow requiring more than one sanitary napkin or tampon per day. The following information was recorded in electronic case report form: start and stop date of MPA administration as well as dates of any spotting/bleeding. Duration of spotting, bleeding and also spotting/bleeding combined is presented.

  Up to Follow-up (Day 112)

• Mean Change in Frequency of Vasomotor Symptoms (VMS) From Baseline at Week 12

  Individual VMS (hot flash or night sweats) events were recorded by participants in an electronic diary (eDiary) using as Global Change Question. The frequency was assessed using the question 1 as "Since you started the study medication, how has the number of your hot flashes (including night sweats) changed?". the response was rated on a 7-point scale from +3 to -3, where +3=A great deal better, +2=Moderately better, +1=A little better, 0=No change, -1=A little worse, -2=Moderately worse and -3=A great deal worse. The score ranged from +3 to -3, where +3 implied absence of symptoms and lower score implied more severe symptoms. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Adjusted mean is presented as least square mean.

  Baseline (Week 0) and Week 12

• Mean Change in Severity of VMS From Baseline at Week 12

  Individual VMS (hot flash or night sweats) events were recorded by participants in an eDiary using global change questions. VMS severity was as follows: mild=score of 1 (brief wave of heat with minimal discomfort, usually without perspiration; able to continue activity \[or sleep\]), moderate=score of 2(heat with some discomfort, usually with perspiration; minimal interruption of activity \[or sleep\]), severe=score of 3(intense heat with considerable discomfort, usually with heavy sweating; may be unable to resume activity \[or sleep\] right away) and extremely severe=score of 4 (unbearable heat with intense discomfort, usually with pouring sweat; may be unable to resume activity \[or sleep\] for quite a while). Total score ranged from 1 to 4 and is the sum of severity scores divided by total number of VMS events. Higher score indicates worst condition. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.

  Baseline (Week 0) and Week 12

• Change From Baseline in Thrombotic Marker- Fibrinogen at Week 12

  Thrombotic marker included fibrinogen. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.

  Baseline (Week 0) and Week 12

• Change From Baseline in Thrombotic Marker- Tissue Plasminogen Activator (tPA) Antigen at Week 12

  Thrombotic marker included tPA antigen. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.

  Baseline (Week 0) and Week 12

• Change From Baseline and Week 12 in Inflammatory Marker- High Sensitivity C-reactive Protein (Hs-CRP) at Week 12

  Inflammatory marker included hs-CRP. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.

  Baseline (Week 0) and Week 12

• Change From Baseline and Week 12 in Inflammatory Marker- Endothelin-1 at Week 12

  Inflammatory marker included Endothelin-1. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.

  Baseline (Week 0) and Week 12

• Change From Baseline and Week 12 in Hematology Parameter- Hematocrit at Week 12

  Hematology parameter included hematocrit. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.

  Baseline (Week 0) and Week 12

• Change From Baseline in Hematology Parameter- Mean Corpuscle Hemoglobin (MCH) at Week 12

  Hematology parameter included MCH. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.

  Baseline (Week 0) and Week 12

• Change From Baseline in Hematology Parameter- Mean Corpuscle Volume (MCV) at Week 12

  Hematology parameter included MCV. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.

  Baseline (Week 0) and Week 12

• Change From Baseline in Hematology Parameter- Red Blood Cell (RBC) Count at Week 12

  Hematology parameter included RBC count. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.

  Baseline (Week 0) and Week 12

• Change From Baseline in Hematology Parameters- Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Week 12

  Hematology parameters included Hemoglobin and MCHC. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.

  Baseline (Week 0) and Week 12

• 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

  Hematology parameters included basophils, eosinophils, lymphocytes, monocytes, platelet count, segmented neutrophils, total neutrophils and WBC count. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline and Week 12 in basophils, eosinophils, lymphocytes, monocytes, platelet count, segmented neutrophils, total neutrophils and WBC count are presented.

  Baseline (Week 0) and Week 12

• Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein at Week 12

  Clinical chemistry parameters included albumin and total protein. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.

  Baseline (Week 0) and Week 12

• Change From Baseline in Clinical Chemistry Parameters- Creatinine, Direct Bilirubin, Total Bilirubin and Uric Acid at Week 12

  Clinical chemistry parameters included creatinine, direct bilirubin, total bilirubin and uric acid. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.

  Baseline (Week 0) and Week 12

• Change From Baseline in Clinical Chemistry Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST) at Week 12

  Clinical chemistry parameters included ALT, ALP and AST. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.

  Baseline (Week 0) and Week 12

• Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (C02) Content, Chloride, Phosphorous, Inorganic, Potassium, Sodium and Urea at Week 12

  Clinical chemistry parameters included calcium, C02 content, chloride, phosphorous, inorganic, potassium, sodium and urea. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.

  Baseline (Week 0) and Week 12

Secondary Outcomes (22)

• Mean Change in Frequency of VMS From Baseline to Weeks 4 and 8

  Baseline (Week 0) to Week 8

• Mean Change in Severity of VMS From Baseline to Weeks 4 and 8

  Baseline (Week 0) to Week 8

• 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%

  Baseline (Week 0) and Week 12

• 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%

  Baseline (Week 0) and Week 12

• Change in Menopause Quality of Life (MENQoL) Score From Baseline to Visits 6 (Week 4) and Visit 8 (Week 12)

  Baseline (Week 0) to Week 12

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Other: Placebo

GSK232802

ACTIVE COMPARATOR

GSK232802

Drug: GSK232802

PREMARIN

EXPERIMENTAL

PREMARIN

Drug: PREMARIN

Interventions

Other: Placebo DRUG

Placebo

GSK232802 DRUG

GSK232802

PREMARIN DRUG

Also known as: Other: Placebo, GSK232802

PREMARIN

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women aged 40 to 65 years old; postmenopausal defined as:
• i.Amenorrheic for at least 12 consecutive months\* OR ii.At least 6 weeks post-surgical bilateral oophorectomy† with or without hysterectomy.
• \*Note: Although duration of amenorrhea is initially determined by subject history at the time of the screening visit (Visit 1), menopausal status must be confirmed by demonstrating levels of follicle stimulating hormone (FSH) \>40 mIU/mL (SI: \>40 IU/L) and estradiol \<35pg/mL (SI: \<128pmol/L) at entry. Screening reports provided by the Central Laboratory must be carefully reviewed to determine menopause eligibility prior to conducting Visit 2 assessments. In the event a subject's menopause status has been clearly established (for example, the subject indicates she has been amenorrheic for 10 years), but FSH and/or estradiol levels are not consistent with a post-menopausal condition, determination of subject eligibility should be discussed with the study medical monitor.
• †For women who are surgically menopausal, a copy of the pathology report or a statement on letterhead from the subject's physician documenting both ovaries have been removed or biochemical evidence of post-menopausal status as noted above is required prior to conducting Visit 2 assessments.
• A minimum average frequency of seven daily moderate to extremely severe hot flashes or episodes of night sweats sufficient to cause the patient to seek treatment (these episodes must be documented during the baseline period and the subject must have recorded frequency and severity of symptoms for a minimum of eight days in order to be eligible for randomization). This average frequency will be calculated by summing the number of moderate, severe, and extremely severe VMS events during the baseline period and dividing by the total number of non-missing days during this period, with details related to the definition of non-missing days described in Section 6.3.1.
• BMI within the range 19 to 35 kg/m2, inclusive.
• Subject has provided signed and dated written informed consent before admission to the study.
• Subject is able to understand and comply with the protocol requirements, instructions, and protocol-stated restrictions.

You may not qualify if:

• Investigator considers subject unfit for the study as a result of medical history, physical examination, or screening tests.
• Use of prescription or non-prescription drugs including:
• i.Hormone therapy (estrogen or estrogen/progestin combination or related products) within the following time period prior to conduct of Visit 1 assessments:
• weeks for prior vaginal hormonal products (rings, creams, gels) or transdermal estrogen or estrogen/progestin products.
• weeks for oral estradiol (e.g., micronized estradiol) or SERM products (e.g., raloxifene).
• weeks for prior oral conjugated (equine or synthetic) estrogen or estrogen/progestin products or for prior intrauterine progestin therapy.
• months for prior progestin implants or injectable estrogen.
• months for prior estrogen pellet therapy or injectable progestin. ii.Use of putative therapies for VMS relief (e.g., selective serotonin reuptake inhibitors \[SSRIs\], serotonin-norepinephrine reuptake inhibitors \[SNRIs\], clonidine, gabapentin, tibolone, methyldopa, and the phytoestrogens black cohosh and red clover) within the past 30 days or 5 half-lives (whichever is longer) prior to conduct of Visit 1 assessments (note: half-lives will be provided in the SPM). Use of non-medication treatments for VMS, such as acupuncture and biofeedback, and other complementary or alternative therapies for VMS relief (with the exception of black cohosh and red clover which require a specified washout previously noted) must be discontinued at Visit 1.
• iii.Use of weight loss drugs (e.g., phentermine, sibutramine, orlistat, rimonabant) within 3 months of the first dose of investigational product. Other complementary or alternative therapies for weight reduction must be discontinued at Visit 1. See SPM for listing.
• iv.Use of pravastatin \[Pravachol/Lipostat\], rosuvastatin \[Crestor\], or pitavastatin \[Livalo\] within the past 30 days or 5 half-lives (whichever is longer) of the first dose of investigational product (note: half-lives will be provided in the SPM. Uses of other statins, for example simvastatin \[Zocor\], atorvastatin \[Lipitor\], fluvastatin \[Lescol\], lovastatin \[Mevacor\] is allowed).
• v.Use of bupropion, orphenadrine \[Norflex\], cyclophosphamide, efavirenz, ifosfamide, or methadone (because of the potential for GSK232802 to inhibit CYP2B6), or use of paclitaxel, torsemide, amodiaquine, repaglinide, rosiglitazone, or pioglitazone (because of the potential for GSK232802 to inhibit CYP2C8) within the past 30 days or 5 half-lives (whichever is longer) of the first dose of investigational product (note: half-lives will be provided in the SPM).
• \- Use of investigational drug within the past 30 days or 5 half-lives (whichever is longer) before the first dose of investigational product.
• Uterine disease or medical condition including:
• Bi-layer endometrial thickness greater than 5mm as determined by TVUS, or for women with a non-informative TVUS, a single layer thickness of greater than 3 mm determined by SIS; presence of fibroids that obscure evaluation of endometrium by TVUS;
• Evidence of an endometrial polyp with hyperplastic or malignant epithelium;

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (87)

GSK Investigational Site

Chandler, Arizona, 85225, United States

Location

GSK Investigational Site

Glendale, Arizona, 85308, United States

Location

GSK Investigational Site

Scottsdale, Arizona, 85251, United States

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GSK Investigational Site

Tucson, Arizona, 85710, United States

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GSK Investigational Site

Poway, California, 92064, United States

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GSK Investigational Site

San Diego, California, 92103, United States

Location

GSK Investigational Site

San Diego, California, 92108, United States

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GSK Investigational Site

Aurora, Colorado, 80012, United States

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GSK Investigational Site

Boulder, Colorado, 80301, United States

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GSK Investigational Site

Denver, Colorado, 80202, United States

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GSK Investigational Site

Wheat Ridge, Colorado, 80043, United States

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GSK Investigational Site

Washington D.C., District of Columbia, 20036, United States

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GSK Investigational Site

Crystal River, Florida, 34429, United States

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GSK Investigational Site

Fort Myers, Florida, 33916, United States

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GSK Investigational Site

Jacksonville, Florida, 32259, United States

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GSK Investigational Site

Miami, Florida, 33143, United States

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GSK Investigational Site

Pinellas Park, Florida, 33781, United States

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GSK Investigational Site

Atlanta, Georgia, 30328, United States

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GSK Investigational Site

Savannah, Georgia, 31405, United States

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GSK Investigational Site

Overland Park, Kansas, 66202, United States

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GSK Investigational Site

Louisville, Kentucky, 40291, United States

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GSK Investigational Site

Sunset, Louisiana, 70584, United States

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GSK Investigational Site

Saint Clair Shores, Michigan, 48081, United States

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GSK Investigational Site

Billings, Montana, 59102, United States

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GSK Investigational Site

Las Vegas, Nevada, 89119, United States

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GSK Investigational Site

Las Vegas, Nevada, 89146, United States

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GSK Investigational Site

New Brunswick, New Jersey, 08901, United States

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GSK Investigational Site

Albuquerque, New Mexico, 87102, United States

Location

GSK Investigational Site

Albuquerque, New Mexico, 87106, United States

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GSK Investigational Site

Chapel Hill, North Carolina, 27599-7570, United States

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GSK Investigational Site

Cincinnati, Ohio, 45249, United States

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GSK Investigational Site

Cleveland, Ohio, 44122, United States

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GSK Investigational Site

Eugene, Oregon, 97401, United States

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GSK Investigational Site

Portland, Oregon, 97205, United States

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GSK Investigational Site

Philadelphia, Pennsylvania, 19114, United States

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GSK Investigational Site

Hilton Head Island, South Carolina, 29926, United States

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GSK Investigational Site

Dallas, Texas, 75234, United States

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GSK Investigational Site

Midland, Texas, 79707, United States

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GSK Investigational Site

Norfolk, Virginia, 23507, United States

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GSK Investigational Site

Seattle, Washington, 98105, United States

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GSK Investigational Site

Tacoma, Washington, 98405, United States

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GSK Investigational Site

Buenos Aries, Buenos Aires, C1425AWC, Argentina

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GSK Investigational Site

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1117ABH, Argentina

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GSK Investigational Site

Buenos Aires, 1012, Argentina

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GSK Investigational Site

Buenos Aires, 1425, Argentina

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GSK Investigational Site

Buenos Aires, C1128AAF, Argentina

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GSK Investigational Site

Mendoza, 5500, Argentina

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GSK Investigational Site

Auchenflower, Queensland, 4066, Australia

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GSK Investigational Site

Kippa-Ring, Queensland, 4021, Australia

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GSK Investigational Site

Dulwich, South Australia, 5065, Australia

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GSK Investigational Site

Nedlands, Western Australia, 6009, Australia

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GSK Investigational Site

Subiaco, Western Australia, 6008, Australia

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GSK Investigational Site

Frankfurt am Main, Hesse, 60322, Germany

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GSK Investigational Site

Frankfurt am Main, Hesse, 60439, Germany

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GSK Investigational Site

Mühlheim am Main, Hesse, 63165, Germany

Location

GSK Investigational Site

Hanover, Lower Saxony, 30159, Germany

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GSK Investigational Site

Münster, North Rhine-Westphalia, 48149, Germany

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GSK Investigational Site

Dresden, Saxony, 01307, Germany

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GSK Investigational Site

Leipzg, Saxony, 04109, Germany

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GSK Investigational Site

Leipzig, Saxony, 04103, Germany

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GSK Investigational Site

Magdeburg, Saxony-Anhalt, 39112, Germany

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GSK Investigational Site

Magdeburg, Saxony-Anhalt, 39122, Germany

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GSK Investigational Site

Nordhausen, Thuringia, 99734, Germany

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GSK Investigational Site

Berlin, 12163, Germany

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GSK Investigational Site

Hamburg, 22159, Germany

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GSK Investigational Site

Napoli, Campania, 80131, Italy

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GSK Investigational Site

Bologna, Emilia-Romagna, 40138, Italy

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GSK Investigational Site

Modena, Emilia-Romagna, 41100, Italy

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GSK Investigational Site

Florence, Tuscany, 50134, Italy

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GSK Investigational Site

Auckland, 0622, New Zealand

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GSK Investigational Site

Christchurch, New Zealand

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GSK Investigational Site

Wellington, New Zealand

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GSK Investigational Site

Lugo, 27002, Spain

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GSK Investigational Site

Oviedo, 33006, Spain

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GSK Investigational Site

Santiago de Compostela, 15706, Spain

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GSK Investigational Site

Gothenburg, SE-411 15, Sweden

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GSK Investigational Site

Gothenburg, SE-411 17, Sweden

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GSK Investigational Site

Gothenburg, SE-411 37, Sweden

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GSK Investigational Site

Gothenburg, SE-416 85, Sweden

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GSK Investigational Site

Kungsbacka, SE-434 30, Sweden

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GSK Investigational Site

Uddevalla, SE-451 30, Sweden

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GSK Investigational Site

Cambridge, Cambridgeshire, CB2 2GG, United Kingdom

Location

GSK Investigational Site

Buckshaw Village, Chorley, Lancashire, PR7 7NA, United Kingdom

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GSK Investigational Site

Manchester, Lancashire, M15 6SX, United Kingdom

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GSK Investigational Site

Harrow, Middlesex, HA1 3UJ, United Kingdom

Location

GSK Investigational Site

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

GSK Investigational Site

Waterloo, Liverpool, L22 0LG, United Kingdom

Location

MeSH Terms

Conditions

Hot Flashes

Interventions

Estrogens, Conjugated (USP)

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2008
• First Posted: January 30, 2008
• Study Start: July 17, 2007
• Primary Completion: July 23, 2008
• Study Completion: July 23, 2008
• Last Updated: October 3, 2017
• Results First Posted: October 3, 2017

Record last verified: 2017-09

Locations

IT (4); SE (6); AU (5); US (41); AR (6); DE (13); NZ (3); GB (6); ES (3)