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Gender Dysphoria clinical trials

View clinical trials related to Gender Dysphoria.

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NCT ID: NCT06439290 Recruiting - Surgery Clinical Trials

Voice Outcome of Glottoplasty, Cricothyroid Approximation, Thyroplasty, and Chondrolaryngoplasty

Start date: April 10, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to measure the short- and long-term voice outcome and outcome predictors of glottoplasty, cricothyroid approximation, thyroplasty, and chondrolaryngoplasty using a prospective non-randomized controlled trial and a multidimensional voice assessment protocol. Secondly, a laryngeal magnetic resonance imaging protocol will be developed to measure pre- and postoperative anatomical factors and compare them with the acoustic changes.

NCT ID: NCT06428669 Recruiting - Gender Dysphoria Clinical Trials

Effect of Nitropaste in Chest Masculinizing Surgery

Start date: August 15, 2022
Phase: Phase 4
Study type: Interventional

Nitropaste is a topical agent that contains 2% nitroglycerin. It is an effective vascular smooth dilator, with more powerful effect on venous vasculature than arterial vasculature. While its main indication is for angina pectoris, there have been many studies showing improved survival of axial and random pattern flaps. Furthermore, recent clinical studies highlight significantly decreased mastectomy flap wound complication and need for sharp debridement. Nitropaste has low rates of side effects and is very well tolerated in general. To this date, there's no study that investigates its utility on patients who are undergoing chest masculinizing surgery. The purpose of this study is to investigate the potential utility of nitropaste in reducing rates of wound complications in patients undergoing chest masculinizing surgery.

NCT ID: NCT06400199 Recruiting - Clinical trials for Gender Dysphoria, Adolescent

Fertility Preservation for Transfeminine Adolescents Via Semen Cryopreservation or Testicular Sperm Extraction

TESE
Start date: July 1, 2022
Phase:
Study type: Observational [Patient Registry]

The goal of this observational cohort study is to identify and predict parameters for successful testicular sperm extraction (TESE) procedures or semen cryopreservation more accurately and to evaluate the decision making process and the experience of postponing or temporarily discontinuing puberty suppression to undergo successful fertility preservation. in transfeminine (assigned male at birth) adolescents. The main question[s] it aims to answer are: - What is the optimal timing for fertility preservation before the start or after temporarily discontinuing puberty suppression puberty suppression - How do transfeminine adolescents and their parents experience the decision making process of fertility preservation - how do transfeminine adolescents and their parents experienced postponing or temporarily discontinuing puberty suppression to undergo successful fertility preservation? Participants will be asked to use their medical data, answer a questionnaire or participate in a (online) interview.

NCT ID: NCT06351501 Not yet recruiting - Clinical trials for Cross Sex Hormonal Treatment in Adolescents With Gender Dysphoria

Evaluation of the Effectiveness of Hormonal Treatment in Adolescents Suffering From Gender Dysphoria

TRANSADO
Start date: June 6, 2024
Phase: Phase 3
Study type: Interventional

Gender dysphoria (GD) is a significant suffering lasting more than 6 months in a subject, regarding the gap felt between gender identity of someone and birth sex. From the start of puberty, most of these adolescents who identify as transgender will persist in this sense and will engage in hormonal-surgical reassignment at some stage. For these adolescents, International recommendations for good practice recommend early treatment at the beginning of pubertal development (Tanner 2) to block pubertal progression, with the possibility of hormonal transition by administration of sex hormones of the desired sex at the age of 16. However, in order to reduce the psychosocial consequences of GD, more and more reference teams are practicing this hormonal transition from the age of 14 without any randomized study showing its benefit compared to a transition at the age of 16 years old. Indeed, in the absence of treatment, comorbidities among adolescents suffering from gender dysphoria is very high, with anxiety and depression, suicidal risk and school dropout. Our hypothesis is that when hormonal transition is started at an age closer to what physiological puberty would be, it will reduce comorbidities and improve quality of life of these adolescents. This is the first therapeutic randomized study in France on this transgender adolescent population, a field where international recommendations based on "Evidence Based Medicine" principles are scared. We hope that results of this study will guide transgender youth health care allowing them, if the study is positive, to access hormonal treatments earlier and improve their overall functioning, their anxious and depressive symptoms, their quality of life.

NCT ID: NCT06291675 Recruiting - Gender Dysphoria Clinical Trials

Gender-Affirming Hormone Therapy and Its Impact on Myocardial Mass and Cardiac Function, Heart, Liver and Pancreatic Fat Content

Start date: March 3, 2023
Phase:
Study type: Observational

Background: Gender affirming hormone therapy (GAHT) leads to profound changes in sex hormone levels, carrying a wide range of implications for major physiological processes in the body. GAHT has been shown to be associated with changes in cardiovascular parameters, the insulin system, body composition, and the psychological state. However, despite the fact that GAHT is usually a long-term intervention, the majority of the research concerns itself with an overall short duration of the therapy and the data on the mid- to long-term effects of GAHT is scarce. Objectives: The study aims to investigate the effects of gender affirming hormone therapy on the cardiovascular risk profile, insulin system, body composition, various metabolic parameters, and the psychological state after 2, 5, and 10 years of the treatment. Study design: The study is designed as an observational longitudinal monocentric study, which includes transgender men and transgender women who have been taking gender affirming hormone therapy during the past 2 years and took part in our pilot study. Our probands will undergo a magnetic resonance scan, extensive bloodwork, an oral glucose tolerance test, and a psychological self-assessment after 2, 5, and 10 years of the treatment. Materials and methods: The magnetic resonance imaging and spectroscopy will be performed with a 3-Tesla magnetic resonance device. We will also perform an extensive blood analysis and an 75g- 2h oral glucose tolerance test. Additionally, the psychological state of the probands will be assessed with 3 questionnaires. Study population: 30 transgender men 30 transgender women who participated in our pilot study and have been taking the gender affirming hormone therapy for the past 2 years. Relevance and implications of the study: The majority of previous research has focused on the short-term effects of gender affirming hormone therapy. Contrastingly, our study aims to focus on the effects of hormone therapy at 2, 5 and 10 years after the beginning of the treatment. Moreover, our study group utilizes measurements of myocardial, hepatic, and pancreatic fat content as well as an MR-assisted measurement of cardiac function, which is a topic that has not been present in research into the effects of gender affirming hormone therapy outside of our pilot study.

NCT ID: NCT06247267 Recruiting - Hypogonadism Clinical Trials

The Effect of Sex Steroid Replacement Therapy in the Hypogonadism and Transgender Active-Duty Population

Start date: March 1, 2019
Phase:
Study type: Observational

It has been known that both estrogen and testosterone are the major sex steroids regulating bone metabolism and other physiological changes in both male and female, respectively. In postmenopausal women, osteoporosis is a major concern secondary to the lack of estrogen. These patients also experience a number of physiological changes that affect their life permanently to include hot flashes, irritability, difficulty concentrating, depression and mental confusion. In hypogonadal men, testosterone deficiency could lead to higher prevalence of depression, osteoporosis, fracture and frailty. Given the new military policy starting to support treatment for gender identity dysphoria military personnel, the number of transgender patients in our Endocrinology clinic has been slowly increasing over the past several months. These patients will require either testosterone replacement therapy or estrogen therapy to achieve their desired sexual characteristics. However, as mentioned above, the lack of estrogen or testosterone in female and male, respectively, could cause several issue in their body composition, cognitive function and quality of life. We designed this prospective case-control study to include patients with hypogonadism and the transgendered populations to learn about the long-term effects of these hormonal replacement therapies on bone density, fractures, memory/cognitive function and quality of life. This is a repetitive measures study taken at baseline, 6-months, and 12-months for three groups consisting of at least 75 subjects. The study will involve 3 arms, i.e. Group 1 primary/secondary untreated hypogonadism, Group 2 male-to female (MTF), and Group 3 female-to-male (FTM) participants that are planning to start hormone replacement therapy as per standard clinical guidelines.

NCT ID: NCT06245681 Recruiting - Gender Dysphoria Clinical Trials

Effects of Cross-sex Hormone Treatment on Cardiac Function, Myocardial and Hepatic Fat Content

Start date: October 20, 2017
Phase:
Study type: Observational

Background: Sex hormones are believed to play an important role in the development and progression of cardiovascular disease. However, the gender gap in onset and mortality is not yet completely understood. Transsexuals undergoing hormone therapy are a promising collective for analyzing the effects of sex hormones on atherosclerosis and other cardiovascular disease. Objectives of the study: To identify gender-specific cardiovascular changes attributed to high-dose hormone therapy in male-to-female (MtF) and female-to-male(FtM) transgender using sonography and magnet resonance spectroscopy. Study design: Longitudinal cohort study. Transsexuals will undergo two 3 Tesla MRI scan sessions: 1. baseline (before hormone treatment) and 2. after 6 months of treatment. An oral glucose tolerance test (OGTT) will be performed at baseline and 6 months after treatment onset. We propose an overall study duration of 12 months. Materials and Methods: MRI measurements will be performed on a 3 Tesla scanner. Study population: 10 FtM, 10 male-to-female MtF transsexuals (aged 18-50), free of hormone-medication at baseline. Relevance and implications of the study: Changes in atherosclerotic risk due to hormone therapy have been studied to no definite results and so far, little is known about the effects of hormone therapy on hepatic and myocardial fatty tissue. Hence this study will provide important new data on the broad clinical aspects of sex hormones as hormone replacement therapy in particularly opposite-sex hormone therapy.

NCT ID: NCT06098781 Recruiting - Gender Dysphoria Clinical Trials

Gynaecological Gender-affirming Surgeries

Start date: September 2, 2022
Phase:
Study type: Observational [Patient Registry]

The goal of this prospective cohort study is to learn about the patient report outcomes after gynaecological gender-affirming surgeries (i.e. hysterectomy, tubectomy, colpectomy) among trans-masculine and non-binary individuals (assigned female at birth). The main question it aims to answer are: • What is the experienced effect of gynaecological gender-affirming surgeries Participants will be asked to fill out a questionaire pre-operatively and 3,9 and 18 months post-operatively.

NCT ID: NCT06022562 Recruiting - Gender Dysphoria Clinical Trials

Effects of Gender-affirming Hormone Therapy on Transgender People

Start date: January 8, 2024
Phase:
Study type: Observational

This prospective cohort study aims to assess the impact of gender-affirming hormone therapy (GAHT) on transgender individuals' physical, psychological, social, and quality of life aspects. Based on gender minority stress theory, the research recruits 150 individuals each of those starting GAHT and those not yet undergoing it. Data collection involves questionnaires and physiological measurements. Statistical analyses will explore correlations and group differences. Findings can guide transgender individuals considering hormone therapy and enhance care guidelines to improve their overall well-being.

NCT ID: NCT05925361 Recruiting - Vaginal Neoplasms Clinical Trials

Peritoneum Vaginoplasty; Implementation According to IDEAL Framework

PeriVaS
Start date: May 25, 2023
Phase: N/A
Study type: Interventional

This study aims to assess if a single flap peritoneum vaginoplasty is safe and feasible.The IDEAL framework for evaluation and implementation of surgical techniques will be used. There are two patient groups who are eligible to undergo this procedure. The first group consists of transgender women who either have a shortage of penile skin (so they cannot undergo standard operation technique: penile inversion) or a stenosis of their primary neovagina. The second group consists of women who are born without a vagina or have an acquired short or absent vagina after vaginectomy or hysterectomy because of malignancy of the cervix or vagina. At the moment, standard procedure for both groups in the Amsterdam University Medical Center (UMC) is the sigmoid vaginoplasty, where a part of the bowel is used to form a vaginal cavity. This procedure is risky, because in some cases, the bowel anastomosis is defect. An other more frequent complication, is malodorous excessive discharge. Sometimes accompanied by inflammation of the diversion neovagina. In recent years, the use of the peritoneum vaginoplasty has been described for transgender women. However, the peritoneum is either used as small flaps to deepen the vagina, or the peritoneum is pulled down, which limits the depth of the neovagina. We want to implement a different technique, where the peritoneum is harvested in a single pedicled flap, which is brought down and sutured in the cavity cylinder shaped. The risks are the same as in any laparoscopic surgery, but we suspect the risk of failure of the anastomosis is much lower, as is the chance of a temporary stoma.