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Women's Health Trials

Studies focused on women's hormonal and reproductive health conditions. 428 recruiting now nationwide.

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Concomitant Treatment with Topical Hyaluronic Acid and High Concentration Oxygen Therapy (Vaginal Natural Oxygenation Device - VNOD) in the Improvement of Symptoms Related to Genitourinary Syndrome of Menopause in Women with Natural and Oncological Postmenopause: Open-Label, Single-Center, Randomize

Genitourinary Syndrome of Menopause

The Caress study is a single-center, open-label, randomized controlled trial (RCT) evaluating the efficacy of a combined treatment using topical hyaluronic acid and high-concentration oxygen therapy (Vaginal Natural Oxygenation Device - VNOD) in improving symptoms of Genitourinary Syndrome of Menopause (GSM) in postmenopausal women, including those with a history of breast cancer. The primary objective is to assess vaginal dryness improvement one month after treatment, comparing two groups: an experimental group receiving VNOD therapy with hyaluronic acid and a control group using a hyaluronic acid-based gel (Hydeal-Dยฎ). Secondary endpoints include the evaluation of additional vaginal symptoms (pain, irritation, itching, sexual health, quality of life) up to six months post-treatment. The study will enroll 80 women (40 with a history of breast cancer and 40 without). Statistical analysis will use chi-square tests and logistic regression to compare symptom severity reduction between the two groups. With a duration of 18 months, the study aims to provide an innovative, non-hormonal treatment option to improve the quality of life for postmenopausal women, particularly those with a history of breast cancer

Pavia18+ yrsWomen
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Is Repetitive Transcranial Magnetic Stimulation Effective in Reducing Endometriosis-associated Pain

Endometriosis ยท Pain

The goal of this research is to improve pain outcomes for the over 500K Canadian women, girls and gender-diverse individuals who are newly diagnosed with endometriosis each year. Chronic pain that persists after interventions for endometriosis is a huge problem. There is some evidence that endometriosis-associated pain (EAP) is, at least to some extent, associated with changes in pain physiology, particularly central sensitization of pain. There is currently no effective evidence-informed intervention that addresses EAP. Yet a recent feasibility trial on a repetitive transcranial magnetic stimulation (rTMS) intervention demonstrated promising results compared to a sham intervention for reducing pain in a sample with EAP. The objectives of this trial are: 1. to evaluate the effectiveness of an rTMS intervention for pain reduction among those with recalcitrant post-operative EAP, 2. to inform on the utility of a long (10 session) vs short (5 session) protocol for pain reduction among those with recalcitrant post-operative EAP 3. to determine if any improvements in pain observed 30 days after an rTMS intervention are retained 6 months later 4. to identify physical and psychosocial mediators that impact the successful reduction of pain among patients with EAP treated using rTMS. 5. to describe patients' perceptions of and satisfaction with rTMS as an intervention for EAP.

Ottawa18โ€“60 yrsWomen
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The Good Pain Consultation in Endometriosis.

Pelvic Pain Syndrome ยท Endometriosis ยท Dysmenorrhea

This PhD project investigates the effect of "the good pain consultation" and early integration of biopsychosocial pain education with current standard management of endometriosis. Our goal is to facilitate self-management of pain and improve health-related quality of life (HRQOL) using limited resources. Our research question is: Does a good pain consultation improve pain self-efficacy and HRQOL, compared to usual care at 3 months and 1 year.? Researchers will compare a good pain consultation to a control group that will receive usual care. Participants will: Attend a consultation and biopsychososial pain education plus usual care or usual care alone. They will answer questions in an internet-based questionnaires three times point during the study.

Kristiansand16โ€“50 yrsWomen
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MRI-Based Prediction of Dienogest Response in Endometriosis

Endometriosis, Ovarian

The goal of this prospective observational study is to learn whether magnetic resonance imaging (MRI) findings can help predict treatment response to dienogest in women with endometriosis. Endometriosis is a common gynecologic condition that can cause chronic pelvic pain and negatively affect quality of life. Although dienogest is widely used as a standard medical treatment, individual responses to treatment vary. The main questions this study aims to answer are: * Whether baseline MRI characteristics of endometriotic lesions are associated with improvement in pelvic pain after dienogest treatment. * Whether MRI findings can help identify patients who are more likely to benefit from dienogest therapy. Participants diagnosed with endometriosis who are prescribed dienogest as part of their routine clinical care will be enrolled. This study does not assign any investigational intervention. Participants will undergo standard clinical follow-up, including pelvic pain assessment using visual analog scale (VAS) scores, quality of life questionnaires, and routine MRI examinations. Clinical and imaging data will be collected prospectively and analyzed to explore imaging predictors of treatment response.

Sejong19โ€“45 yrsWomen
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Study on the Self-Administered Use of a Specialized Kit for the Management of Sexual Pain Associated With Endometriosis

Endometriosis

Endometriosis is a complex gynecological condition that affects approximately 10% of women of reproductive age, according to 2023 data from the World Health Organization. Endometriosis is often associated with debilitating pain, particularly during sexual intercourse (dyspareunia). This pain profoundly affects these patients' sexual health and, consequently, their quality of life, yet it remains frequently misunderstood and inadequately managed, partly due to a lack of information and appropriate tools. One of the key aspects of this study is the use of the Sexual Activity Questionnaire (SAQ), an internationally recognized assessment tool for measuring the impact of treatment on sexual functioning. The SAQ collects precise data on sexual activity (primarily frequency), the level of sexual pleasure, and the perceived pain potential experienced by patients during sexual activity, assessing not only the intensity of pain but also its influence on the emotional and relational aspects of intimate life. The SAQ has been validated to assess the impact of surgical treatments for endometriosis on sexual functioning. The results obtained through this questionnaire in routine clinical practice formed the basis for the tools developed by Dr. Magalie Benoit, providing an in-depth understanding of the different types of pain experienced by patients. The kit used in the study contains: 1. The Endo-Sexo Guide: A 258-page book that compiles and analyzes possible responses to the SAQ. It explains in detail the mechanisms of sexual pain and offers personalized solutions to alleviate it. 2. The Endo Doute app: It allows women to keep a journal tracking pain (frequency and intensity), the frequency of sexual intercourse, and the tools used to relieve pain (including those provided in the kit). It also allows users to export their data to share with the healthcare professionals involved. 3. A set of practical tools for managing sexual pain on a daily basis, including an endo-vaginal TENS device to treat dyspareunia, penis rings to limit deep penetration, hyaluronic acid suppositories, CBD (cannabinoid) lubricant gel, sublingual CBD oil to reduce stress, as well as two dietary supplements-one containing palmitoylethanolamide (PEA) to combat inflammation and the other made from herbs to aid menstrual comfort. These tools will be used independently by patients, offering them personalized solutions to better understand and manage their pain on their own. Each patient will be able to choose whether or not to use the various components of the kit and how often to use them. Empowering patients to manage their own pain should improve their sexual quality of life and reduce the need for occasional or unscheduled medical care. This project represents the first initiative aimed at evaluating the impact of these tools on patients' autonomy in managing sexual pain related to endometriosis.

Multiple locations18โ€“45 yrsWomen
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Impact of Reducoseยฎ on Glycemic Response and Menopausal Symptoms in Perimenopausal Women (CALM-R)

Glycemic Response ยท Menopause Symptoms

The purpose of this double-blind, randomized, placebo-controlled trial is to. evaluate daily Reducoseยฎ (mulberry leaf extract) supplementation taken with the two largest meals for 12 weeks on improving glycemic response and perimenopausal symptoms in women aged 40-60 years. Glycemic response is measured using Dexcom Stelo continuous glucose monitors during standardized test meals, and menopausal symptoms and sleep/quality-of-life outcomes are assessed using validated surveys administered through the Chloe app in a decentralized U.S. study.

Los Angeles, CA40โ€“60 yrsWomen
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Endometrioma Ethanol Sclerotherapy - Prospective Cohort Study Protocol

IVF ยท Endometrioma

Ovarian endometriomas are cystic masses lined with endometrial tissue that contains fluid arising from a collection of menstrual debris. Ovarian endometriomas clinical manifestations includes pelvic pain, dysmenorrhea, dysfunctional uterine bleeding, and infertility. Endometriomas are most commonly treated either medically or by surgical excision. Ultrasonography (US)-guided aspiration and sclerotherapy is a new approach. Its mechanism of action is believed to be destruction of the inner epithelial lining, which is followed by inflammation and fibrosis, eventually resulting in regression of the cyst. The main advantage in this approach is the avoidance of collateral damage to the ovary.

Multiple locations18โ€“41 yrsWomen
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Lifestyle Medicine: Establishing Clinical Approaches to Chronic Disease for Rural Patients

Obesity ยท Hyperlipidemias ยท Polycystic Ovary Syndrome

Developed nations worldwide are currently enduring a health crisis, as chronic diseases continue to decrease quality of life and promote additional disease states or even death for much of the population. Rural populations are at a particular disadvantage, as they lack access to health clubs, wellness programs and similar resources that are more available in urban areas. Although pharmaceutical therapies have continued to show therapeutic advancements, the rates of disease onset and death from chronic disease has not seen similar improvements, and in fact continue to worsen. Excitingly, significant evidence has been published demonstrating an affordable, effective treatment to directly treat and prevent these chronic diseases, but few have demonstrated successful implementation of this therapy, which is improved lifestyle. Specifically, physical activity and healthy body composition are powerful therapeutics that have been demonstrated to effectively combat and prevent chronic diseases. Additionally, improving these lifestyle factors are often more effective than pharmaceutical interventions without the wide range of side effects. Unfortunately, barriers exist on multiple tiers in the practice of family medicine that demote the implementation of lifestyle medicine. To better serve patients at risk of, or suffering from chronic disease, the investigators are seeking to establish a lifestyle medicine prescription program for rural West Virginia. This program will provide patient education on the benefits of physical activity, body composition, and help patients identify strategies to implement healthy lifestyle choices that can be sustainable for the long-term. Patients will be advised on local opportunities to increase physical activity (yoga studio, martial arts, fitness facilities, aquatic center, etc.) and provided access to the facilities they are most likely to adhere to regularly. They will also be provided training on exercise techniques, equipment, and facilities to increase familiarity and comfort in these settings.

Lewisburg, WV18โ€“64 yrsAll genders
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Deep Endometriosis Affecting the Urogenital Tract: Long-term Outcomes and Impact on Renal Function

Endometriosis ยท Endometriosis (Diagnosis) ยท Urinary Tract Diseases

Endometriosis is a chronic estrogen-dependent disease characterized by the presence and growth of endometrium-like tissue outside the uterine cavity. This ectopic endometrial tissue induces a chronic local and systemic inflammatory response, resulting in the most common manifestations of the disease: chronic pelvic pain, infertility, and pelvic adhesions. In deep endometriosis (DE), adhesions and infiltrative growth may damage adjacent organs. Overall, endometriosis affects approximately 10% of women of reproductive age. Its prevalence is higher among women with infertility (20-50%) and among patients with chronic pelvic pain (up to 90%). The disease is usually categorized as superficial peritoneal, ovarian, or deep endometriosis (DE). Deep endometriosis is a progressive form of the disease that may affect organs beyond the pelvic cavity, including the urinary tract, alter their anatomy, and cause functional impairment. Urogenital involvement occurs in approximately 1-5.5% of all women with endometriosis; the prevalence is substantially higher among patients with DE, reaching 16-53% according to the available literature. Within the urinary tract, the bladder is most commonly affected (70-85%), followed by the ureters (9-23%), kidneys (approximately 4%), and urethra (approximately 2%). Ureteral endometriosis is therefore a relatively rare but clinically significant entity. It may be unilateral or bilateral, with a predominance of left-sided involvement. Two basic forms are distinguished: * "Extrinsic" - ureteral stenosis caused by periureteral fibrosis and the presence of DE lesions without infiltration of the ureteral wall. * "Intrinsic" - ureteral stenosis caused by direct infiltration of the ureteral wall by endometriotic tissue. Ureteral stenosis causes secondary hydronephrosis and, unless treated in a timely manner, may lead to a progressive loss of renal function. The disease frequently remains asymptomatic for a prolonged period. Up to half of cases are diagnosed incidentally or only at an advanced stage, when renal damage is already irreversible. Early detection and timely planning of surgical management are therefore essential for preserving renal function. The main surgical procedures are: * ureterolysis - release of the ureter from fibrotic adhesions, preferred for the extrinsic form; * ureteroneocystostomy (UCNA) - indicated for the intrinsic form when the affected segment must be resected and the ureter reimplanted into the bladder; * ureteroureterostomy (ureteral anastomosis) - appropriate for the intrinsic form when, following resection, the distal ureteral segment is sufficiently long to allow anastomosis of healthy margins. Despite the clinical significance of the condition, prospective studies objectively evaluating the evolution of renal function after the individual types of surgical management of ureteral endometriosis are still lacking. A modern diagnostic strategy combining specialized ultrasound, dynamic renal scintigraphy (MAG3), and analysis of urinary biomarkers of tubular injury (KIM-1, CCL-2, L-FABP) enables earlier detection of renal dysfunction and more accurate monitoring of postoperative recovery. Identification of sensitive biomarkers of early renal injury and validation of an algorithm for their use could substantially improve decisions regarding the timing of surgery and subsequent postoperative follow-up. Based on our experience, some patients surgically treated for hydronephrosis caused by DE-related ureteral stenosis show persistent morphological changes on renal ultrasound and the manifestation of systemic conditions such as arterial hypertension during long-term follow-up. To date, no study has focused on the long-term follow-up of patients with ureteral DE and its potential consequences. The expected benefit of this study is to establish clear criteria for the indication of surgical treatment of ureteral endometriosis and to develop an evidence-based protocol for long-term follow-up.

Multiple locations18+ yrsWomen
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Benefit of GnRH Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and/or Adenomyosis

Endometriosis ยท Adenomyosis ยท Infertility, Female

Women suffering from endometriosis and/or adenomyosis may also suffer from infertility. GnRH agonist injection could improve implantation and therefore increase the pregnancy rate in these patients. This study was designed to evaluate effects of the additional of GnRH agonist (single or 2 doses) to the routine oestrogens and progestins use as support before Frozen Embryon Transfer as compared to oestrogens and progestins only.

Multiple locations18โ€“36 yrsWomen
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Thermogenenic Responses to Fasting and Overfeeding in Women

Obesity

This study plans to learn more about why menopause increases the risk of weight gain. During and after menopause, women are prone to increased weight gain. The weight gained is primarily body fat, particularly visceral or abdominal body fat. The excess gain in abdominal fat during menopause increases the risk of chronic metabolic diseases such as heart disease and diabetes. The increase in weight and body fat with menopause may be due to changes in metabolism related to the loss of estrogen. This study plans to compare how the metabolism of premenopausal and postmenopausal women responds to changes in energy intake. The investigators will compare the changes in energy expenditure that occur during a period of acute fasting (24 hours) and a period of consuming excess calories (overfeeding).

Aurora, CO18โ€“65 yrsWomen
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Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause

Perimenopause ยท PMDD

Transcutaneous Auricular Neurostimulation (tAN) will be administered to women with premenstrual syndrome (PMS), premenstrual dysphoric disorder (PMDD), and perimenopause. The investigators will examine whether tAN improves symptomology by collecting self-report data before the intervention, during the intervention, and following the intervention.

Fort Worth, TX18โ€“55 yrsWomen
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The Impact of a Novel GnRH Antagonist With Add-back Therapy for Treatment of Uterine Fibroids and Endometriosis on Hemostasis Parameters

Uterine Fibroid

Uterine fibroids and endometriosis are two frequent diseases among women of reproductive age. They can be responsible for chronic and/or menstrual pelvic pain and abnormal uterine bleeding. The first-line management of these conditions relies on medical treatment. Hormonal treatment with contraceptive pill can be effective, although up to 30% of patients do not respond to this line of treatment. In this context, GnRH antagonists have been introduced. By suppressing ovulation, they inhibit the action of the gonadal axis and thus can reduce bleeding and pain associated with uterine fibroids and endometriosis. More recently, the GnRH antagonist known as Relugolix has been associated with a low-dose oestradiol and progesteron-line molecule, a medication known as Ryeqo. The goal of this type of treatment is to suppress ovulation while also minimizing symptรดms which may derive from lack of oestrogen and progesterone in reproductive age women. While Ryeqo's efficacy has been proven by multiple large randomized controlled trials, its impact on blood coagulation has yet to be determined. Venous thromboembolism (VTE) is the main, potentially fatal, dleterious effect of oestrogen-containing hormonal treatmen, such as combined oral contraceptives (COC). Several epidemiological studies have found a 3-6 increase in the risk of VTE among women on COC. The thrombogenic risk can be assessed by measuring specific blood biomarkers, which are known to be correlated to the thrombogenic phenotype and allow an overview of the VTE risk prior to conducting large population-scale studies directly measuring the adverse event's prevalence. The aim of this study is to document the effects of Ryeqoยฎ on hemostasis parameters in order to estimate the risk of VTE associated with its employ. An improved understanding of the VTE risk associated with Ryeqoยฎ will allow to adapt hormonal treatment based on each woman's personal risk profile. The study will be explained to all women whose medical condition allows the prescription of Ryeqo. All women who give their consent to participate in the study will have a urinary pregnancy test and a blood sample drawn before beginning treatment with Ryeqo. A second visit will be scheduled at 3 months, throughout which a second blood sample will be drawn. A questionnaire including socio-demographic data and clinical symptoms will be completed both on the first and the second visit.

Geneva18+ yrsWomen
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Endometriosis and Peritoneal Dysbiosis

Endometriosis ยท Infertility Unexplained

Endometriosis is a complex clinical syndrome that impairs many aspects of a woman's life, characterized by a chronic estrogen-dependent inflammatory process, mainly affecting the pelvic organs, with ectopic presence of tissue analogous to the uterine mucosa (endometrium). Despite intensive research in the field of etiopathogenesis, its cause has not yet been determined, and treatment remains symptomatic. Endometriosis causes two main complications, i.e. pelvic pain syndrome and infertility. In recent years, thanks to the analysis of the human microbiome, it has become possible to deepen the knowledge of the physiological and pathological interactions between microorganisms inhabiting various body areas and the host. Bacteria may enter the peritoneal cavity in the mechanism of retrograde menstruation and translocate from the intestines, and then promote the development of local and systemic inflammation, leading to the symptoms of endometriosis. The study is to determine whether the presence of a specific intestinal, peritoneal and uterine microbiome correlates with endometriosis stage and whether its presence predisposes to increased pain or infertility. Concordance or divergence of bacterial populations inhabiting the peritoneal and uterine cavities could have clinical implications, i.e. the possibility of empirical antibiotic therapy in patients undergoing only endometrial aspiration biopsy and not opting for surgical treatment.

Multiple locations18โ€“45 yrsWomen
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Outpatient Visits Versus Telehealth for Postoperative Care After Minimally Invasive Gynecologic Surgery

to Determine Whether Patient Satisfaction With Postoperative Telehealth Follow-up is Non-inferior to In-person Clinic Visits

Telehealth, or telemedicine, utilizes technology to deliver clinical care remotely, either in real time or asynchronously, between clinician and patient. Telemedicine has been successfully implemented to increase healthcare delivery for patients in rural areas with otherwise long travel times, and studies have also determined that telemedicine can increase patient satisfaction scores while simultaneously decreasing direct and indirect costs for patients. Previous scholarship has demonstrated that telemedicine can be a safe alternative to face-to-face postoperative visits for surgical patients, streamlining recovery with no significant delays in the diagnosis of surgical complications. As healthcare systems continue to emphasize value-based care, it is important to assess whether virtual postoperative visits effectively meet patient needs while optimizing resource utilization. Patient-reported outcomes and satisfaction surveys can help identify potential gaps in care and ensure that telehealth is implemented in a way to maximize both efficiency and quality. Our primary objective is to determine whether patient satisfaction with postoperative telehealth follow-up is non-inferior to in-person clinic visits.

Chicago, IL18+ yrsWomen
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Treatment of Vulvo-vaginal Atrophy (VVA) Using Vaginal Dilator in Addition to Usual Treatment

Vulvo Vaginal Atrophy ยท Genitourinary Syndrome of Menopause (GSM) ยท Vaginal Atrophy in Breast Cancer Patients

This is a randomized, controlled trial aiming to evaluate the effectiveness of adding vaginal dilators to the treatment of vulvovaginal atrophy. Study Population: Peri- and postmenopausal women with VVA, including breast cancer survivors. Design: Monocentric pilot RCT evaluating SoC (MHT, lubricants, moisturizers) (control group) to SoC + vaginal dilators (test group). Vaginal Dilator : A silicone medical device will be used for gradual stretching progression. The kit includes dilators of progressively larger sizes. Procedures: Assessments at baseline, at 4 \& 12 weeks Measures : Vulvo Vaginal Atrophy severity , dyspareunia, Vaginal Health Index Score, Female Sexual Fonction Index, and Visual Analogue Scale (for vaginal dryness, vaginal and/or vulvar irritation/itching, and pain during sexual intercourse). Statistical Analysis: Differences at baseline, 4 weeks, and 12 weeks will be tested using: Two-sample t-test Mann-Whitney test Statistical Power: Assuming a 20% improvement in Group 1 and 40% in Group 2, with: p \< 0.05 (type I error) 80% power (type II error), 160 patients needed across both groups. SoC = Standard of care RCT = Randimized control trial MHT = Menopausal hormonal therapy

Brussels18โ€“85 yrsWomen
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Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology

Gynecologic Disease ยท Gynecologic Cancer ยท Endometriosis

GynRAN is an international, multicentre, transversal, diagnostic and non-interventional study carried out in gynecology-obstetrics/gynecological oncology departments that aims to identify a diagnostic signature for gynecological pathologies by analyzing of coding and non-coding RNA contained in patients saliva. The study population consists of patients with clinically symptomatic females with one or more of the gynecological pathologies (endometriosis, adenomyosis, ovarian cysts, fibroids, ovarian/cervical/uterine cancer) and asymptomatic females. The patients concerned by the study will be managed without modification of the care pathway, nor modification of the therapeutic indications, nor modification of the diagnostic or follow-up examinations necessary according to the context, which are carried out according to the local recommendations.

Multiple locations18+ yrsWomen
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Women's Health trials by state