Study Details

Total Page：16

File Type：pdf, Size：1020Kb

Hot Flashes and Night Sweats? If you experience one or more a day, a research study may be an option. To learn more and to see if you may qualify for this study, please contact study staff. What is a clinical research study? A clinical research study evaluates the safety and effectiveness of a study medication. If the [Site Info Sticker Here] study medication is considered to be safe and effective by the regulatory authorities, it may be approved for patient use. Clinical trials are important because they may: yySupplyanswerstospecifichealth-related questions yy Help provide potential new treatment options yy Advance medical knowledge BE-19-044MIT-Do001-C302PatientBrochure_US_English_V2.0_12-Aug-19 Hotflashesandnightsweatscan be uncomfortable and disruptive. Hotflashesarearealmedical condition that can be treated. If youhavemoderate-to-severehot flashes,considerparticipatingin a research study. About the E4Comfort Study? How can I qualify for the study? Why participate? TheE4ComfortStudyisevaluatinganoralstudy You may qualify to participate if you: yyAllstudy-relatedcarewillbeprovidedat medicationtoseeifitmayreducehotflashes no cost yyAreapost-menopausalwomanaged andnightsweatsinpost-menopausalwomen. 40to65years yy The study staff will closely monitor you and The study medication is a synthetic version of your symptoms a natural estrogen called estetrol. Estetrol has yyExperiencemoderate-to-severehotflashes shown in early testing to have minimal side or night sweats yy You will be helping to advance knowledge effects. of women’s health yyStartedmenopausewithinthelast10years Coping with hot flashes and yyDonothaveahistoryofcancer,diabetes, night sweats or heart disease Ahotflashisasuddensensationofheatinthe Additional requirements will apply. The study staff face, neck, chest, or all over that may cause you can provide more details. tobecomeflushedandsweatheavily. Hotflashes Participationinthisstudyiscompletelyvoluntary that happen at night are called night sweats. Up and you may withdraw from the study at any time. to80%ofwomenexperiencehotflashesduring menopause. Hotflashesmaybecausedbyfewerhormones, such as estrogen and progesterone, being produced during menopause. These changes in hormone levels can affect your body’s temperature control system. .

Copy Link

Recommended publications

Progestin-Only Systemic Hormone Therapy for Menopausal Hot Flashes
EDITORIAL Progestin-only systemic hormone therapy for menopausal hot flashes Clinicians treating postmenopausal hot flashes often recommend “systemic estrogen treatment.” However, progestin-only therapy also can effectively treat hot flashes and is an option for women with a contraindication to estrogen therapy. Robert L. Barbieri, MD Editor in Chief, OBG MANAGEMENT Chair, Obstetrics and Gynecology Brigham and Women’s Hospital Boston, Massachusetts Kate Macy Ladd Professor of Obstetrics, Gynecology and Reproductive Biology Harvard Medical School he field of menopause medi- women. In one study, 133 postmeno- in postmenopausal women with cine is dominated by studies pausal women with an average age an American Heart Association risk T documenting the effective- of 55 years and approximately 3 years score greater than 10% over 10 years.3 ness of systemic estrogen or estro- from their last menstrual period were Additional contraindications to sys- gen-progestin hormone therapy for randomly assigned to 12 weeks of temic estrogen include women with the treatment of hot flashes caused treatment with placebo or micronized cardiac disease who have a throm- by hypoestrogenism. The effective- progesterone 300 mg daily taken at bophilia, such as the Factor V Leiden ness of progestin-only systemic bedtime.1 Mean serum progesterone mutation.4 hormone therapy for the treatment levels were 0.28 ng/mL (0.89 nM) and For women who are at high risk of hot flashes is much less studied 27 ng/mL (86 nM) in the women taking for estrogen-induced cardiovascu- and seldom is utilized in clinical placebo and micronized progesterone, lar events, micronized progesterone practice.
[Show full text]
6 Ways Your Brain Transforms During Menopause
6 Ways Your Brain Transforms During Menopause By Aviva Patz Movies and TV shows have gotten a lot of laughs out of menopause, with its dramatic hot flashes and night sweats. But the midlife transition out of our reproductive years—marked by yo-yoing of hormones, mostly estrogen—is a serious quality-of-life issue for many women, and as we're now learning, may leave permanent marks on our health. "There is a critical window hypothesis in that what is done to treat the symptoms and risk factors during perimenopause predicts future health and symptoms," explains Diana Bitner, MD, assistant professor at Michigan State University College of Human Medicine and author of I Want to Age Like That: Healthy Aging Through Midlife and Menopause. "If women act on the mood changes in perimenopause and get healthy and take estrogen, the symptoms are much better immediately and also lifelong." (Going through menopause and your hormones are out of whack? Then check out The Hormone Reset Diet to balance your hormones and lose weight.) For many decades, the mantra has been that the only true menopausal symptoms are hot flashes and vaginal dryness. Certainly they're the easiest signs to spot! But we have estrogen receptors throughout the brain and body, so when estrogen levels change, we experience the repercussions all over—especially when it comes to how we think and feel. Two large studies, including one of the nation's longest longitudinal investigations, have revealed that there's a lot going on in the brain during this transition. "Before it was hard to tease out: How much of this is due to the ovaries aging and how much is due to the whole body aging?" says Pauline Maki, PhD, professor of psychiatry and psychology at the University of Illinois at Chicago and Immediate Past President of the North American Menopause Society (NAMS).
[Show full text]
Duloxetine and Escitalopram for Hot Flushes: Efficacy and Compliance in Breast Cancer Survivors
Original Article Duloxetine and escitalopram for hot flushes: efficacy and compliance in breast cancer survivors N. BIGLIA, MD, PHD, Gynaecology and Obstetrics Unit, Umberto I Hospital, Department of Surgical Sciences, University of Turin, Turin, V.E. BOUNOUS, MD, Gynaecology and Obstetrics Unit, Umberto I Hospital, Department of Surgical Sciences, University of Turin, Turin, T. SUSINI, MD, PHD, Breast Unit Department of Health Science, OB & GYN Section, AOU Careggi, School of Medicine, University of Florence, Florence, S. PECCHIO, MD, Gynaecology and Obstetrics Unit, Umberto I Hospital, Department of Surgical Sciences, University of Turin, Turin, L.G. SGRO, MD, PHD, Gynaecology and Obstetrics Unit, Umberto I Hospital, Department of Surgical Sciences, University of Turin, Turin, V. TUNINETTI, Gynaecology and Obstetrics Unit, Umberto I Hospital, Department of Surgical Sciences, University of Turin, Turin, & R. TORTA, MD, PHD, Psycho-Oncology Unit, Department of Neurosciences, University of Turin, Turin, Italy BIGLIA N., BOUNOUS V.E., SUSINI T., PECCHIO S., SGRO L.G., TUNINETTI V. & TORTA R. (2016) Euro- pean Journal of Cancer Care Duloxetine and escitalopram for hot flushes: efficacy and compliance in breast cancer survivors Selective serotonin reuptake inhibitors (SSRI) and serotonin–norepinephrine reuptake inhibitors (SNRI) might be an effective treatment for hot flushes (HFs) in breast cancer survivors (BCSs). This study aims to compare the efficacy and tolerability of duloxetine (SNRI) versus escitalopram (SSRI) in reducing frequency and severity of HFs in BCSs and to assess the effect on depression. Thirty-four symptomatic BCSs with emotional impairment received randomly duloxetine 60 mg daily or escitalopram 20 mg daily for 12 weeks. Patients were asked to record in a diary HF frequency and severity at baseline and after 4 and 12 weeks of treatment.
[Show full text]
[Product Monograph Template
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrORILISSA® elagolix (as elagolix sodium) tablets 150 mg and 200 mg Gonadotropin releasing hormone (GnRH) receptor antagonist Date of Preparation: October 4, 2018 AbbVie Corporation Date of Revision: 8401 Trans-Canada Highway March 3, 2020 St-Laurent, Qc H4S 1Z1 Submission Control No: 233793 ORILISSA Product Monograph Page 1 of 40 Date of Revision: March 3, 2020 and Control No. 233793 RECENT MAJOR LABEL CHANGES Not applicable. TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ............................................................... 4 1. INDICATIONS ................................................................................................................ 4 1.1. Pediatrics (< 18 years of age): .................................................................................. 4 1.2. Geriatrics (> 65 years of age): .................................................................................. 4 2. CONTRAINDICATIONS ................................................................................................. 4 3. DOSAGE AND ADMINISTRATION ................................................................................ 5 3.1. Dosing Considerations ............................................................................................. 5 3.2. Recommended Dose and Dosage Adjustment ......................................................... 5 3.3. Administration .........................................................................................................
[Show full text]
The Evaluation of Spells
r e V i e W the evaluation of spells I.N. van Loon1*, J. Lamberts1, G.D. Valk2, A.F. Muller1 1Department of Internal Medicine, Diakonessenhuis, Utrecht, the Netherlands, 2Department of Internal Medicine, University Medical Centre Utrecht, Utrecht, the Netherlands, *corresponding author: tel.: +31 (0)88- 25 05 901, e-mail: [email protected] a B s t r a C t the differential diagnosis of spells is broad and includes table 1. Differential diagnosis of episodic symptoms both innocent and life-threatening conditions with a endocrine pharmacological considerable overlap in clinical presentation. extensive Pheochromocytoma Abrupt withdrawal of adrener- diagnostic testing is often performed, without reaching a Thyreotoxicosis gic inhibitor final diagnosis, or resulting in false-positives. a thorough Hypogonadism (menopause) MAO inhibitor in combination Medullary thyroid carcinoma with specific food medical history, including family history and medication, Pancreatic islet cell tumours Sympathicomimetic and physical examination are required to obtain clues (e.g. insulinoma, VIPoma) Hallucinating drugs (cocaine, Gastroenteropancreatic LSD) about the cause of a spell. an overview of spells with their neuroendocrine Chlorpropamide-alcohol flush stereotypic phenotype in general internal medicine practice tumours (carcinoid syndrome) Vancomycin is presented in this article. Besides, a diagnostic approach Hypoglycaemia Calcium antagonist is proposed for the clinical evaluation of spells. Cardiovascular neurological Labile hypertension Autonomic neuropathy
[Show full text]
Non-Hormonal Strategies for Managing Menopausal Symptoms in Cancer Survivors: an Update
Non-hormonal strategies for managing menopausal symptoms in cancer survivors: an update Nicoletta Biglia1, Valentina E Bounous1, Francesco De Seta2, Stefano Lello3, Rossella E Nappi4 and Anna Maria Paoletti5 1Division of Gynecology and Obstetrics, Department of Surgical Sciences, School of Medicine, University of Torino, Largo Turati 62, 10128 Torino, Italy 2Institute for Maternal and Child Health-IRCCS ‘Burlo Garofolo’, University of Trieste, via dell’Istria 65/1, 34137 Trieste, Italy 3Department of Woman and Child Health, Policlinico Gemelli Foundation, Largo Gemelli 1, 00168 Rome, Italy 4Research Center for Reproductive Medicine, Gynecological Endocrinology and Menopause, IRCCS S Matteo Foundation, Department of Clinical, Surgical, Diagnostic and Paediatric Sciences, University of Pavia, Viale Camillo Golgi 19, 27100 Pavia, Italy 5 Department of Obstetrics and Gynecology, Department of Surgical Sciences, University of Cagliari, University Hospital of Cagliari, SS 554 km 4,500, 09042 Monserrato, Italy Abstract Vasomotor symptoms, particularly hot flushes (HFs), are the most frequently reported symptom by menopausal women. In particular, for young women diagnosed with breast cancer, who experience premature ovarian failure due to cancer treatments, severe HFs are an unsolved problem that strongly impacts on quality of life. The optimal manage- ment of HFs requires a personalised approach to identify the treatment with the best Review benefit/risk profile for each woman. Hormonal replacement therapy (HRT) is effective in managing HFs but it is contraindicated in women with previous hormone-dependent cancer. Moreover, many healthy women are reluctant to take HRT and prefer to manage symptoms with non-hormonal strategies. In this narrative review, we provide an update on the current available non-oestrogenic strategies for HFs management for women who cannot, or do not wish to, take oestrogens.
[Show full text]
ORILISSA® (Elagolix) HCP Patient Counseling Guide
How it works What are possible How do I start Savings & Use & Important What is ORILISSA? & experience side effects? taking ORILISSA? support Safety Information MAKE THE MOVE TO ORILISSA TOGETHER Review this guide with your patients to help them understand their ORILISSA treatment plan and make an informed start together. WHAT IS ORILISSA? ORILISSA® (elagolix) is a prescription medicine used to treat moderate to severe pain associated with endometriosis. It is not known if ORILISSA is safe and effective in children. SAFETY CONSIDERATIONS Do not use ORILISSA if you are pregnant, have osteoporosis or severe liver disease, take medicines called organic anion transporting polypeptide (OATP) 1B1 inhibitors that are known or expected to significantly increase the blood levels of elagolix (the active ingredient in ORILISSA), or have had a serious allergic reaction to ORILISSA or any of the ingredients in ORILISSA. ORILISSA does not prevent pregnancy. It may alter your period, so watch for other signs of pregnancy. Stop taking ORILISSA if you become pregnant. Ask about proper birth control, as some may affect how ORILISSA works. ORILISSA may affect how some birth control works. ORILISSA can cause serious side effects, including bone loss, abnormal liver tests, suicidal thoughts or behaviors, and worsening mood. Talk to your healthcare provider right away if you notice changes such as jaundice, dark amber-colored urine, suicidal thoughts or actions, depression, or worsening mood. 1 Please see Use and additional Important Safety Information on page 7, and full Prescribing Information at rxabbvie.com/pdf/orilissa_pi.pdf. How it works What are possible How do I start Savings & Use & Important What is ORILISSA? & experience side effects? taking ORILISSA? support Safety Information What is ORILISSA? ORILISSA is a pill that’s clinically proven to help relieve endometriosis pain.
[Show full text]
Estetrol for Menopause Symptoms: the Cinderella of Estrogens Or Just Another Fairy Tale? Nancy King Reame, MSN, Phd, FAAN
CE: D.C.; MENO-D-20-00177; Total nos of Pages: 3; MENO-D-20-00177 Menopause: The Journal of The North American Menopause Society Vol. 27, No. 8, pp. 000-000 DOI: 10.1097/GME.0000000000001601 ß 2020 by The North American Menopause Society EDITORIAL Estetrol for menopause symptoms: the Cinderella of estrogens or just another fairy tale? Nancy King Reame, MSN, PhD, FAAN espite the advent of lower dosing, transdermal deliv- affinity (<5%) compared to E2.3 Interest was, however, ery, and targeted use in younger age groups, safety renewed in the 2000s when preclinical and pharmacokinetic D concerns persist regarding the potential for estrogen- studies showed that estetrol elicits considerable estrogenic based menopause hormone therapy (MHT) to raise breast effects in rat models for both hot flashes and bone loss, but cancer and thromboembolism risk. In the last few decades a with minimal stimulation of liver and breast.4 More recent wealth of scientific advances has revealed the molecular biol- translational studies5 showed that E4 was bestowed with an ogy of the estrogen receptors (ERs) a and b, opening up new intriguing ER pharmacology, unique from SERMs, thus directions for their pharmaceutical manipulation and promise pushing it to center stage for its potential as the first native to improve hormone therapies. With the help of the ER knock- estrogen with selective action in tissues (NEST). out mouse model, an array of estrogen-mediated actions in Unlike other estrogens, which interact with both a and b tissues throughout the body was elucidated, followed by the receptors at the cell surface and in the nucleus, E4 not only emergence of new compounds with tissue-dependent, ER preferentially binds to the ERa subtype, but does so in a distinct agonistic, antagonistic, and mixed actions.1 Although several non-SERM way.
[Show full text]
Elagolix for Treating Endometriosis
Elagolix for Treating Endometriosis Evidence Report June 15, 2018 Prepared for ©Institute for Clinical and Economic Review, 2018 ICER Staff/Consultants University of Colorado Skaggs School of Pharmacy Modeling Group* Steven J. Atlas, MD, MPH R. Brett McQueen, PhD Director, Primary Care Research and Quality Assistant Professor Improvement Network Department of Clinical Pharmacy Massachusetts General Hospital Center for Pharmaceutical Outcomes Research Geri Cramer, BSN, MBA Jonathan D. Campbell, PhD Research Lead, Evidence Synthesis Associate Professor Institute for Clinical and Economic Review Department of Clinical Pharmacy Center for Pharmaceutical Outcomes Research Patricia G. Synnott, MALD, MS Senior Research Lead, Evidence Synthesis Melanie D. Whittington, PhD Institute for Clinical and Economic Review Research Instructor Department of Clinical Pharmacy Varun Kumar, MBBS, MPH, MSc Health Economist Samuel McGuffin Institute for Clinical and Economic Review Professional Research Assistant Department of Clinical Pharmacy Celia Segel, MPP Program Manager Institute for Clinical and Economic Review Daniel A. Ollendorf, PhD Chief Scientific Officer *The role of the University of Colorado Skaggs Institute for Clinical and Economic Review School of Pharmacy Modeling Group is limited to the development of the cost-effectiveness Steven D. Pearson, MD, MSc model, and the resulting ICER reports do not President necessarily represent the views of CU. Institute for Clinical and Economic Review DATE OF PUBLICATION: June 15, 2018 Steven Atlas served as the lead author for the report. Geri Cramer and Patricia Synnott led the systematic review and authorship of the comparative clinical effectiveness section. Varun Kumar was responsible for oversight of the cost-effectiveness analyses and developed the budget impact model.
[Show full text]
Evaluation of Core and Surface Body Temperatures, Prevalence, Onset, Duration and Severity of Hot Flashes in Men After Bilateral Orchidectomy for Prostate Cancer
Clinical Urology Hot Flashes After Bilateral Orchidectomy International Braz J Urol Vol. 34(1): 15-22, January - February, 2008 Evaluation of Core and Surface Body Temperatures, Prevalence, Onset, Duration and Severity of Hot Flashes in Men after Bilateral Orchidectomy for Prostate Cancer Naseem A. Aziz, Chris F. Heyns Department of Urology, University of Stellenbosch and Tygerberg Hospital, Cape Town, South Africa ABSTRACT Objective: To assess the prevalence, onset, duration and severity of hot flashes in men after bilateral orchidectomy (BO) for prostate cancer, to evaluate body temperature changes during hot flashes and to determine whether an elevated temperature within a few days after BO can be caused by deprivation of androgen. Materials and Methods: Patients (n = 101) were questioned about the characteristics of their hot flashes after BO for prostate cancer. A subgroup of these men (n = 17) were instructed to record their oral and forehead temperatures during and at fixed intervals between hot flashes daily for 4 weeks. Results: The mean age was 71.6 years, mean follow-up after BO was 33.2 months. Hot flashes were reported by 87 men (86%) with previous spontaneous remission in 9 (10%). The median time between BO and the onset of hot flashes was 21 days (range 1-730), median number of hot flashes 3 per day (range 1-20), and median duration was 120 seconds (range 5 to 1800). There was no significant difference between median oral (36.4o C) and forehead (36.0o C) temperature in the normal state, but during hot flashes the median forehead temperature (37.0o C) was higher than the oral temperature (36.5o C) (p = 0.0004).
[Show full text]
Reduction in Menopause-Related Symptoms Associated with Use of a Noninvasive Neurotechnology for Autocalibration of Neural Oscillations
Menopause: The Journal of The North American Menopause Society Vol. 22, No. 6, pp. 000/000 DOI: 10.1097/gme.0000000000000422 * 2015 by The North American Menopause Society Reduction in menopause-related symptoms associated with use of a noninvasive neurotechnology for autocalibration of neural oscillations Charles H. Tegeler, MD,1 Catherine L. Tegeler, BS,1 Jared F. Cook, MA,1 Sung W. Lee, MD, MSc,2 and Nicholas M. Pajewski, PhD3 Abstract Objective: Increased amplitudes in high-frequency brain electrical activity are reported with menopausal hot flashes. We report outcomes associated with the use of High-resolution, relational, resonance-based, electro- encephalic mirroringVa noninvasive neurotechnology for autocalibration of neural oscillationsVby women with perimenopausal and postmenopausal hot flashes. Methods: Twelve women with hot flashes (median age, 56 y; range, 46-69 y) underwent a median of 13 (range, 8-23) intervention sessions for a median of 9.5 days (range, 4-32). This intervention uses algorithmic analysis of brain electrical activity and near real-time translation of brain frequencies into variable tones for acoustic stimula- tion. Hot flash frequency and severity were recorded by daily diary. Primary outcomes included hot flash severity score, sleep, and depressive symptoms. High-frequency amplitudes (23-36 Hz) from bilateral temporal scalp recordings were measured at baseline and during serial sessions. Self-reported symptom inventories for sleep and depressive symptoms were collected. Results: The median change in hot flash severity score was j0.97 (range, j3.00 to 1.00; P = 0.015). Sleep and depression scores decreased by j8.5 points (range, j20 to j1; P = 0.022) and j5.5 points (range, j32 to 8; P = 0.015), respectively.
[Show full text]
Antidepressants & Antiepileptics: an Attractive Alternative for Hot Flushes
Open Access Journal of Reproductive System and Sexual Disorders DOI: ISSN: 2641-1644 10.32474/OAJRSD.2019.02.000142Review Article Antidepressants & Antiepileptics: An Attractive Alternative for Hot Flushes Belardo María Alejandra1*, Pilnik Susana2, De Nardo Bárbara3, Starvaggi Agustina3, Gonzalez Yamil Aura3 and Glassmann Rocio3 1Department of Gynecology, Instituto Universitario del Hospital Italiano de Buenos Aires, Argentina 2Department of Gynecology, Member of the Scientific Committee of the Argentine Society of Gynecological and Reproductive Endocrinology, Hospital Italiano de Buenos Aires, Argentina 3Department of Gynecology, Hospital Italiano de Buenos Aires, Argentina *Corresponding author: Belardo María Alejandra, Department of Gynecology, Italiano de Buenos Aires Hospital, Argentina Received: July 05, 2019 Published: July 16, 2019 Abstract hormonalTwo of treatmentthe most common is contraindicated complaints aboutor due menopause to the patient’s are hot refusal flashes to and use night it. Serotonin-norepinephrinesweats. Although menopause reuptake hormone inhibitors therapy (MHT) is considered the gold standard treatment for hot flashes, many women request non-hormonal treatments either because (SNRIs), selective serotonin reuptake inhibitors (SSRIs), pregabalin and gabapentin seem to be an attractive alternative for women toKeywords: ameliorate the frequency and severity of menopausal vasomotor symptoms (VMS). Hot Flashes; Night Sweats; Nonhormonal Treatment; Antidepressants; Antiepileptics Introduction alternative therapies are necessary. Several non-estrogen options The North American Menopause Society (NAMS) describes hot have been evaluated, these include the anticonvulsant gabapentin and pregabalin, selective serotonin reuptake inhibitors (SSRIs) and flashes as a spontaneous sensation of warmth affecting the face, serotonin-norepinephrine reuptake inhibitors (SNRIs). neck and upper chest, and are often associated with palpitation and sweating followed by chills [1].
[Show full text]