CompletedPhase 2

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

United States356 participantsStarted 2007-07-17

Plain-language 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.

Who can participate

Age range40 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: * 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 ho…

What they're measuring

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

Timeframe: Up to 21 weeks

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

Timeframe: Baseline (Week 0) and Week 12

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

Timeframe: Baseline (Week 0) and Week 12

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

Timeframe: Baseline (Week 0) and Week 12

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

Timeframe: Baseline (Week 0) and Week 12

Change From Baseline in Fasting Lipid Profile at Week 12

Timeframe: Baseline (Week 0) and Week 12

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

Timeframe: Baseline (Week 0) to Week 12

Trial details

NCT IDNCT00604825

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-07-23

Results submitted2017-09-06

View on ClinicalTrials.gov More Menopausal and Female Climacteric States trials

Who can participate

Age range40 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Up to 21 weeks

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

Timeframe: Baseline (Week 0) and Week 12

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

Timeframe: Baseline (Week 0) and Week 12

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

Timeframe: Baseline (Week 0) and Week 12

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

Timeframe: Baseline (Week 0) and Week 12

Change From Baseline in Fasting Lipid Profile at Week 12

Timeframe: Baseline (Week 0) and Week 12

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

Timeframe: Baseline (Week 0) to Week 12