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Hot Flashes clinical trials

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NCT ID: NCT02176083 Completed - Breast Cancer Clinical Trials

Reproductive Health Survivorship Care Plan Pilot

Start date: March 20, 2014
Phase: N/A
Study type: Interventional

Most young breast cancer patients undergo chemotherapy and/or endocrine therapy, treatments that impair ovarian function and result in significant reproductive health late effects. These late effects include symptoms of estrogen deprivation (e.g., hot flashes and vaginal dryness), which are distressing in young breast cancer survivors (YBCS). The goal of this pilot study is to test the feasibility of a 4-week text message based intervention on hot flashes and vaginal dryness in YBCS. YBCS will be randomized in a 1:1 ratio to the intervention (text messages on hot flash and vaginal dryness management) and control arms. All participants will be prompted to provide daily hot flash frequency and severity via text messaging. The primary hypothesis is YBCS will have high rates of daily hot flash reporting via text messaging. Secondarily, we will compare changes in hot flash frequency, hot flash severity and vagina dryness between the intervention and control arms.

NCT ID: NCT02100540 Completed - Hot Flashes Clinical Trials

A Study to Evaluate the Effects of RCN3028 on Moderate to Severe Vasomotor Symptoms in Women

RDC
Start date: March 19, 2014
Phase: Phase 2
Study type: Interventional

Hot flashes are the most common symptom of menopause and affect almost 75% of menopausal women. Clinical evidence indicates potent antagonists of 5-HT2A are more likely to cause hypothermia. Risperidone is a potent 5-HT2A and a dopamine D2 receptor antagonist and is proposed to have effect on reduciton of hot flashes through its dopaminergic and serotonergic antagonism. The primary purpose of this study is to determine if RCN3028 is effective and safe in the treatment of moderate to severe vasomotor symptoms associated. In accordance with the latest FDA guidance study participants will have a minimum of 7 moderate to sever hot flashes per day, or 50 per week at baseline.

NCT ID: NCT02092844 Completed - Insomnia Clinical Trials

Cognitive Behavioral Therapy for Insomnia and Nocturnal Hot Flashes in Menopause

Start date: January 2015
Phase: N/A
Study type: Interventional

The primary aim of the current study is to evaluate the effectiveness of a Cognitive Behavioral Therapy intervention in the treatment of menopause-associated insomnia and nocturnal hot flashes.

NCT ID: NCT02070718 Completed - Clinical trials for Treatment of Menopausal Hot Flashes

Effects of a Kappa Agonist on Hot Flashes in Menopausal Women

Start date: January 2013
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT02062528 Completed - Menopause Clinical Trials

Hot Flashes and Omega 3

BOOM3
Start date: March 2014
Phase: N/A
Study type: Interventional

The main objective is to evaluate the effects of omega-3 fatty acids on hot flashes frequency.

NCT ID: NCT02040532 Completed - Menopause Clinical Trials

Gabapentin for Insomnia Symptoms and Nighttime Vasomotor Symptoms (VMS) in Peri- and Postmenopausal Women

Start date: January 2014
Phase: N/A
Study type: Interventional

The broad goal of this study is to obtain pilot data to determine the tolerability and preliminary efficacy of the non-hormonal agent gabapentin for insomnia symptoms and nighttime vasomotor Symptoms (VMS) when open-label gabapentin is administered at low dose and only at night in peri- and postmenopausal women. We hypothesize that the majority of participants will be able to increase and tolerate treatment, and insomnia symptoms and the frequency of nighttime VMS will improve on low-dose gabapentin dosed at bedtime.

NCT ID: NCT01987778 Completed - Menopause Clinical Trials

Health Effects of Resistance Training on Postmenopausal Women

Start date: November 2013
Phase: N/A
Study type: Interventional

Today's women will live more than a third of their lives after menopause, i.e. with a changed hormonal and metabolic state. Vasomotor symptoms like hot flushes and sweating are reported by about 75% of all women around menopause and may impair well-being, mental state, daily activities and night sleep. Vasomotor symptoms are less prevalent in women who participate in regular physical exercise. It is, however, still uncertain if physical exercise reduces vasomotor symptoms. The purpose of this randomized controlled study is to establish possible beneficial health effects from 15 weeks of supervised resistance training (RT) on postmenopausal women. End-points include effects from RT in postmenopausal women on 1. clinical outcomes (number and severity of vasomotor symptoms, Health-Related quality of Life (HRQoL), Body Mass Index (BMI), abdominal height, muscle strength and mass, browning of fat), 2. diagnostic variables (production of myokines as irisin, immunological markers) and 3. genetic variables (length of telomeres). The control group will be offered resistance training after the intervention period.

NCT ID: NCT01957306 Completed - Hot Flashes Clinical Trials

Safety and Efficacy of Dr. Tagliaferri's Menopause Formula

Start date: November 2013
Phase: Phase 2
Study type: Interventional

The primary goal of this study is to evaluate the safety and efficacy of 12 weeks of treatment of 4 grams/day of Dr. Tagliaferri's Menopause Formula (administered as 2 grams PO BID) in reducing the frequency of menopausal vasomotor symptoms among healthy, postmenopausal women, aged 40-65, with moderate to severe hot flushes.

NCT ID: NCT01936441 Completed - Sleep Clinical Trials

MsFLASH-04: Pilot Trial: Telephone Behavioral Therapy for Menopause-related Sleep Disturbance

MsFLASH-04
Start date: November 2013
Phase: N/A
Study type: Interventional

Self-reported sleep complaints are common in peri- and postmenopausal women and have been identified as a key symptom of the menopausal transition. The MsFLASH study, A Pilot Trial of Telephone-Based Cognitive-Behavioral Therapy for Midlife Women with Menopause-related Sleep Disturbance, is a randomized, single-blind, placebo-controlled, two arm clinical trial. The target population will include women in general good health, aged 40-65 years, who report symptoms of insomnia (trouble sleeping) and who are bothered by hot flashes. We plan to enroll 100 women from Seattle, Washington and surrounding areas into the trial. Half of the women will be randomly assigned to receive the behavioral intervention and half to receive the behavioral control. The intervention arm participants will receive 6 sessions of a telephone-based, cognitive-behavioral therapy intervention for insomnia (CBT-I), based on state-of-the-art methods and specifically targeted to women with menopause-related sleep disturbance (CBT-I). The control arm participants will receive telephone-based Menopause Education Control (MEC) that includes elements of sleep hygiene. Assessments for both groups will be collected at baseline (pre-randomization), 8-week post-randomization, and 6-month post-randomization. The inclusion/exclusion criteria are designed to target broadly those midlife women who have menopause-related sleep disturbance and also report being bothered by vasomotor symptoms. This target population defines the clinical population seeking treatment for relief of menopause-related sleep problems. Exclusion criteria are kept minimal and intended only to exclude women with significant medical problems likely to account for their sleep problems (instead of menopause), or likely to interfere with their ability to participate in the intervention. We include women taking hormone therapy or other medication who meet these criteria because they are part of the population seeking clinical care for relief of sleep disturbances. Our primary objective is to develop an intervention that is generalizable to the greatest number of women and maximally translatable into real-world primary care practice.

NCT ID: NCT01896791 Completed - Hot Flashes Clinical Trials

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

Start date: July 2013
Phase: N/A
Study type: Interventional

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.