CompletedPhase 2

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

United States, Argentina, Australia356 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 range

40 Years – 65 Years

Sex

FEMALE

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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)

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 range

40 Years – 65 Years

Sex

FEMALE

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)