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Active clinical trials for "Hot Flashes"

Results 51-60 of 227

A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of...

Vasomotor Symptoms Associated With MenopauseHot Flashes

Researchers are looking for a better way to treat women who have hot flashes after women have been through the menopause. Hot flashes are caused by the hormonal changes that happen when a woman's body has been through the menopause. Menopause is when women stop having a menstrual cycle, also called a period. During the menopause, the ovaries increasingly produce less sex hormones as a result of the natural ageing process and related hormonal adjustments. The decline in hormone production can lead to various symptoms which, in some cases, can have a very adverse effect on a menopausal woman's quality of life. The study treatment, elinzanetant, was developed to treat symptoms caused by hormonal changes. It works by blocking a protein called neurokinin from sending signals to other parts of the body, which is thought to play a role in starting hot flashes. There are treatments for hot flashes in women who have been through the menopause, but may cause medical problems for some people. In this study, the researchers will learn how well elinzanetant works compared to a placebo in women who have been through the menopause and have hot flashes. A placebo looks like a treatment but does not have any medicine in it. To compare these study treatments, the doctors will ask the participants to record information about the participants' hot flashes in an electronic diary. The researchers will study the number of hot flashes the participants have and how severe the hot flashes are. The researchers will look at the results from before treatment, after 4 weeks, and after 12 weeks of treatment. The participants in this study will take two capsules of either elinzanetant or the placebo once a day. The participants who take elinzanetant will take it for 26 weeks. The participants who take the placebo will take it for 12 weeks and then take elinzanetant for the next 14 weeks. During the study, the participants will visit the site approximately 9 times and perform 1 visit by phone. Each participant will be in the study for approximately 36 weeks. The treatment duration will be 26 weeks. During the study, the participants will: record information about the participants' hot flashes in an electronic diary answer questions about the participants' symptoms The doctors will: check the participants' health take blood samples ask the participants questions about what medicines the participants are taking and if the participants are having adverse events An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if doctors do not think the adverse events might be related to the study treatments.

Completed18 enrollment criteria

Embr Thermal Device for Hot Flash Management in Prostate Cancer

Prostate CancerHot Flashes

This study is being conducted to evaluate if the Embr thermal device is useful for men who experience bothersome hot flashes as a result of prostate cancer treatment.

Completed17 enrollment criteria

A Study of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause

Vasomotor Symptoms

This study is for women in menopause who have moderate to severe hot flashes. It is for women who are unable to use hormone replacement therapy (HRT). Menopause, a normal part of life, is the time after a woman's last period. Hot flashes often occur during menopause. They can disrupt a woman's daily life. The study medicines (also called investigational products, or IP) are tablets of fezolinetant or placebo. An investigational product means that the product is not yet licensed. In this study, a placebo is a dummy treatment that looks like fezolinetant but does not have any medicine in it. The study will compare fezolinetant with the placebo to learn if fezolinetant reduces the number and severity of hot flashes. Women that want to take part in the study will be given an electronic handheld device with an app to track their hot flashes. Some women may be able to use the app on their own smartphone. In the last 10 days before their next clinic visit, the women will record information about their hot flashes. They can take part in the study if they have an average of 7 or more moderate to severe hot flashes each day. Women will be picked for 1 of 2 treatments (fezolinetant or placebo) by chance alone. Women who take part in the study will take 2 tablets every day for 24 weeks. Treatment will be double-blinded. That means that the women in the study and the study doctors will not know who takes which of the study medicines (fezolinetant or placebo). The women will continue recording information about their hot flashes on the electronic device or their phone. They will also use another device to answer questions about how hot flashes affect their daily life. During the study, the women will visit their study clinic several times for a check-up. This will happen during Weeks 2, 4, 8, 12, 16, 20, 24, and 27. Some women may be able to have home visits instead, from Week 2 to Week 20. At the check-up, they will be asked if they have any medical problems. Other checks will include vital signs (heart rate, temperature and blood pressure) and some blood samples taken for laboratory tests. At some check-ups, the women will have a physical exam. In Week 2 and Week 24, the women will have an ECG to check their heart rhythm. Women who have a uterus will also have a test called a transvaginal ultrasound. A probe is gently placed inside the vagina. Sound waves will create a picture of the organs in the pelvis. This will allow the study doctor to look more closely at the uterus and surrounding organs. The last check-up (at Week 27) will be 3 weeks after they take their last tablets of study medicine (fezolinetant or placebo).

Completed23 enrollment criteria

Effects of a Kappa Agonist on Hot Flashes in Menopausal Women

Treatment of Menopausal Hot Flashes

Studies suggest that kappa agonists (KA) and peripherally restricted kappa agonists (PRKAs) may affect thermoregulation. This pilot study has the aim to establish proof of concept regarding efficacy of an oral kappa agonist (KA) for the treatment of menopausal hot flashes.

Completed16 enrollment criteria

Transcranial Direct Current Stimulation (tDCS) in Vasomotor Symptoms of Menopause

Hot Flashes

Climacteric or Menopausal Transition is defined as the time period where there is a change to non-reproductive reproductive life, with extension of variable length. During this period, and after the establishment of Menopause and non-functioning ovarian, the appearance of various symptoms that express the depletion of ovarian follicles is common; among these symptoms, the most frequently reported by women are vasomotor symptoms or hot flashes. In addition to hormonal therapy, other medications have been employed in an attempt to improve these symptoms; although they present better results than placebo, yet have little clinical impact in reducing vasomotor symptoms. Therefore, this gap allows the evaluation of alternative therapies, such as Transcranial Direct Current Stimulation (tDCS). The rationale for studying the effect of this technique in this context is its possible autonomic modulatory effect. What reinforces the choice of this technique is the fact that it demonstrated efficacy in other pathologies such as depression, pain, Parkinson's disease, among others. Transcranial direct current stimulation (tDCS) is a renewed method of non-invasive brain modulation. It is based on a transcranial application of weak direct currents in a non-invasive, simple and painless manner. Its use in the treatment of vasomotor symptoms has not been studied. The objective of this study is to evaluate the improvement of vasomotor symptoms in postmenopausal women, after application of tDCS, and compare them to a control group. This Randomized Clinical Trial will be held in female postmenopausal patients, followed in the outpatient Menopause Clinic of Obstetrics and Gynecology Service, Hospital de Clinicas de Porto Alegre. From these results, it is expected to present a new therapeutic option in the treatment of vasomotor symptoms.

Completed2 enrollment criteria

Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms

Hot Flashes

Estradiol treatment is effective at reducing vasomotor symptoms (eg hot flushes) in postmenopausal women. This study will evaluate the safety and efficacy of Evamist.

Completed7 enrollment criteria

WHAT (Women, Hot-flashes, Activity, Trial) - Physical Activity for Treatment of Hot Flushes Among...

Postmenopausal SymptomsHot Flashes

More than 60 % of women experience hot-flashes during postmenopausal and 20 % have serious symptoms. Use of combined estrogen/progesterone therapy reduces hot-flashes effectively. In 2001, results from the randomized controlled WHI-study (Womens Health Initiative) showed increased risk for breast cancer and hearth-disease among users of combined estrogen/progesterone therapy. This reduced the use of combined estrogen/progesterone therapy. Many women seek alternative treatment for hot-flashes. They are often told that physical activity can reduce intensity and frequency of hot-flashes. The evidence for this advice is sparse. The primary hypothesis tested in the WHAT-study will be: Increased physical activity reduce frequency and intensity of hot-flushes among sedentary postmenopausal women with bothersome hot-flushes. The WHAT-study is designed as a pragmatic randomized controlled clinical trial. To answer the primary hypothesis we will need approximately 500 participants. The logistic in a pragmatic trial of a complex intervention are complicated and we decided to first run a pilot study with 50 participants as a feasibility study. The pilot gives us opportunity to gain experience with possible problems like withdrawals and injuries.

Completed11 enrollment criteria

Efficacy and Safety of a Topical Estradiol Gel for Treatment of Postmenopausal Symptoms

Hot Flashes

The purpose of this study is to determine the efficacy and safety of a topical estradiol gel for the treatment of hot flushes in postmenopausal women.

Completed6 enrollment criteria

Evaluation of SAMe for Hot Flashes

Healthyno Evidence of Disease1 more

RATIONALE: S-adenosyl-L-methionine may help relieve hot flashes in women based upon its ability to potentially modulate serotonin. PURPOSE: This phase II trial is studying the side effects and how well s-adenosyl-L-methionine works in treating hot flashes in women with a history of breast cancer or those who do not wish to take estrogen due to a perceived increased risk of breast cancer.

Completed15 enrollment criteria

Evaluation of the Efficacy and Safety of Common Sage in Controlling Hot Flashes in Prostate Cancer...

Prostate Cancer

The purpose of this clinical phase I study is to measure the efficacy and side effects of Common Sage in the treatment of hot flashes in 10 patients with prostate cancer who receive androgen deprivation (AD) (exclusively or as part of a multimodality treatment) for a period of minimum 6 months. Concomitant use of a non-steroidal anti-androgen during the first month of the AD is permitted to prevent the flair-up phenomenon. However, the inclusion of patients in the study will only start at least 2 weeks after the cessation of the anti-androgen. This is done to exclude a possible influence of the anti-androgen on the severity and frequency of hot flashes. Once the informed consent is signed, the patient receives the study diary to note the daily frequency and severity of hot flashes and their effect on daily quality of life. The severity of the hot flashes is measured by the Moyad scoring scale. The effect on daily quality of life is measured using the Hot Flash Related Daily Interference Scale (HFRDIS). The patient will be instructed in detail how to use the diary. After week 1, the patient returns the diary to the responsible physician. In return the patient receives the study medication (Common Sage, product) and a diary for the next week (=week 2). This procedure will be repeated until the end of the observation period (2 months after enrollment in the study). The common Sage will be provided in tablets. The suggested dose of Common Sage is 3 tablets a day (morning - noon - evening). To be sure that the effect of Common Sage is NOT due to an inhibition of the effect of the LHRH analogue, the related hormones (testosterone, FSH, LH, free testosterone and SHBG) will be tested at three fixed moments: day of study enrollment, 1 month after study enrollment and at the end of the study. In order to check the level of hemoglobin and cholesterol, every 2 weeks a blood count will be performed. It has been shown that LHRH analogues can induce anemia and hypercholesterolemia. The investigators want to measure a possible effect of Common Sage on both. There are no known side-effects of the use of Common Sage. All symptoms that could be related to the use of Common Sage will be recorded in detail. Therefore, a clinical examination including blood pressure registration will be performed by the responsible physician on a weekly base.

Completed7 enrollment criteria
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