Clinical trials: Gender Affirmation Surgery
Erectile Dysfunction, Gender Dysphoria
ZEPHYR: A Study Evaluating Surgical Outcome After Implantation of the Zephyr ZSI 475 FTM Inflatable Penile Implant in the Neophallus After Female-to-male Sex Reassignment Surgery
This study will look into the surgical outcome after implantation of the Zephyr ZSI 475 FTM in the neophallus.
- Trial name
- NCT04064671
- Testing
- Implantation of the Zephyr ZSI 475 FTM erectile implant
- Where
- Belgium
- Volunteers
- 100 people
- Sponsor
- University Hospital, Ghent
Gender Identity Disorder of Adult, Voiding Disorders
Transgender Post-reassignment Urogynecologic Measures and Perceptions
The intent of this mixed methods study for transgender women after gender confirmation surgery is to characterize and subsequently create a validated screening questionnaire for postoperative urologic and pelvic floor symptoms.
- Conditions
- Gender Identity Disorder of Adult, Voiding Disorders, Sexual Dysfunction
- Trial name
- NCT03293771
- Testing
- Focus group interviews, Questionnaire packet
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Weill Medical College of Cornell University
Gender Dysphoria
Development of Effective, Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries
This study will compare the current standard-of-care pain treatment regimen options that are available to patients who undergo gender-affirming surgery.
- Trial name
- NCT04979338
- Testing
- Ultrasound guided Continuous Infraclavicular Brachial Plexus Block, Ultrasound guided Continuous Femoral Nerve Block, Ultrasound guided Pudendal Nerve Block
- Where
- United States
- Volunteers
- 640 people
- Sponsor
- Cedars-Sinai Medical Center
Sexual Functioning, Transgender Men
Evaluating Sexual Functioning in Trans Men During the Gender Affirmation Process: A Mixed Methods Study
Both sexual experiences and the process of gender transition initiated to reduce gender dysphoria carry cultural characteristics.
- Conditions
- Sexual Functioning, Transgender Men, Gender Affirmation Surgery
- Trial name
- ESFTMGAP (NCT07131267)
- Where
- Turkey (Türkiye)
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Eskisehir Osmangazi University
Gender Affirming Surgery, Mastectomy
Gender Affirming Mastectomy Analgesia Rial
Introduction: Optimizing pain management after gender-affirming mastectomy (removal of breast tissue, aka top surgery) surgery is important for recovery and minimizing opioid use.
- Conditions
- Gender Affirming Surgery, Mastectomy, Acute Pain
- Trial name
- GAMA (NCT07861165)
- Testing
- Paravertebral (single injection), Wide local infiltration
- Where
- Canada
- Volunteers
- 64 people
- Sponsor
- Nova Scotia Health Authority
Gender Dysphoria
Effect of Nitropaste in Chest Masculinizing Surgery
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.
- Trial name
- NCT06428669
- Testing
- Nitro-Bid 2 % Topical Ointment
- Where
- United States
- Volunteers
- 256 people
- Sponsor
- University of Virginia
Gender Dysphoria Vaginoplasty Sexuality
Sexual Function of Trans Women After Vaginoplasty
Genital feminine affirming surgery may be an important step for transgender women. Vaginoplasty consists in the creation of external female genitalia and an operational vaginal cavity, and thus responds to major functional and…
- Trial name
- GGAS-SEX (NCT05292820)
- Testing
- Validated and non-validated questionnaire for exploration of sexuality and satisfaction after surgical procedure
- Where
- 3 sites in France
- Volunteers
- 158 people
- Sponsor
- Hospices Civils de Lyon
Neuropathic Pain, Phantom Pain
Neuropathic Pain After Orchidectomy and Sex Reassignment Surgery
Phantom pain is associated with cortical reorganization after amputation. This phenomenon should not play a role in transsexual women, since the cortical representation of the male sex organs is presumably altered.
- Conditions
- Neuropathic Pain, Phantom Pain, Sex Reassignment Surgery
- Trial name
- NPASRS (NCT04538170)
- Testing
- pain after surgery
- Where
- Germany
- Volunteers
- 423 people
- Sponsor
- University Hospital Tuebingen
Gender Dysphoria, Opioid Use
The Effect of Pectoral Blocks on Perioperative Pain in Gender Affirmation Top Surgery
Despite recent advancements with regional and local anesthesia, postoperative pain continues to be a major concern for patients undergoing breast surgery.
- Conditions
- Gender Dysphoria, Opioid Use, Pain, Postoperative
- Trial name
- NCT04474366
- Testing
- Ropivacaine 0.2% Injectable Solution, Saline (0.9%)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of California, San Francisco
Hysterectomy, Gender Affirming Surgery
A Standardized Counseling Approach to Preoperative Education in Transmasculine Individuals Receiving Gender-affirming Surgery
The intervention will be an educational handout provided to a randomized cohort of patients that reviews the benefits and risks of retaining ovaries vs removing them.
- Trial name
- NCT07324967
- Testing
- Educational Handout
- Where
- United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
Pain, Postoperative
Saddle Block With IT Morphine for Penile Inversion Vaginoplasty
Penile Inversion Vaginoplasty (PIV) is a transition-related surgery (TRS) that is associated with severe postoperative pain. The optimal pain management strategies for this surgery remain unknown.
- Trial name
- NCT06556121
- Testing
- Saddle block, pudendal nerve block
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- Women's College Hospital
Gender Affirmation Surgery, Perioperative Care
Support for Transgender and Non-Binary Individuals Seeking Vaginoplasty Study
The STRIVE study is the first national randomized trial to focus on improving well-being, access to surgical care and other health outcomes for transgender and nonbinary (referred to as trans) people seeking genital…
- Conditions
- Gender Affirmation Surgery, Perioperative Care, Transgender Health
- Trial name
- STRIVE (NCT06436560)
- Testing
- STRIVE Peer Support Intervention
- Where
- 9 sites in United States
- Volunteers
- 290 people
- Sponsor
- Oregon Health and Science University
Pregnancy, Smoking Behavior
HISTOLOGICAL RESULTS IN TRANSGENDER INDIVIDUALS ASSIGNED TO FEMALES AT BIRTH UNDERGOING GENDER AFFIRMATION SURGERY AND IN TESTOSTERONE THERAPY
The aim of this study is to report histological results of genital organs removed during gender affirmg surgery in transgender people assigned female at birth (AFAB), to increase the knowledge about the long-term effects of…
- Conditions
- Pregnancy, Smoking Behavior, Testosterone Replacement Therapy, Drugs
- Trial name
- NCT06710496
- Testing
- analysis of medical records
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Mastectomy, Gender Affirmation Surgery
The Role of Amnion Membrane Allografts in Nipple Preservation
The overall objective of this proposal is to conduct a randomized-controlled study to determine whether treatment with dehydrated human amnion/chorion membrane (dHACMs) allografts can improve NAC viability in patients undergoing…
- Conditions
- Mastectomy, Gender Affirmation Surgery, Nipple Sparing Mastectomy, Prophylactic Mastectomy
- Trial name
- AmnioFix (NCT06073808)
- Testing
- AmnioFix dehydrated Human Amnion/Chorion Membrane Allograft, Control Device
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Stanford University
Pain Catastrophizing, Pain, Chronic
Efficacy of a Chronic Pain Treatment Prior to Gender-affirming Surgery
The primary objective of this study is to examine a single-session, 2-hour group intervention provided to a population of transgender or gender-diverse patients with chronic pain prior to gender-affirming surgery, to determine if…
- Conditions
- Pain Catastrophizing, Pain, Chronic, Gender Identity
- Trial name
- NCT06443164
- Testing
- Empowered Relief, Standard of Care
- Where
- United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Oregon Health and Science University
Gender Dysphoria
Patient Reported Outcome on Genital Sensitivity and Sexual Function After Genital Gender Affirming Surgery
For genital gender affirming surgery, it remains unclear to what extent genital sensitivity might be expected and what the impact of this might be on sexual functioning.
- Trial name
- PROGAS (NCT04993469)
- Testing
- Semmes-Weinstein monofilament testing and questionnaires
- Where
- Belgium
- Volunteers
- 200 people
- Sponsor
- University Hospital, Ghent
Neovaginal Microbiome
Flourish Vaginal Care System to Establish Neovaginal Microbiome
This study examines whether use of a commercially-available vaginal wellness system is able to establish a microbiome in transgender women.
- Trial name
- NCT05372770
- Testing
- Flourish Vaginal Care system
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Vaginal Biome Science
Transgender Individuals, Gender Incongruence
Swiss ProspectivE Cohort of TRAnsgender and Gender Diverse Individuals - The SPECTRA Study
The goal of this observational study is to understand the factors influencing the well-being and health of transgender and gender-diverse (TGD) individuals undergoing gender-affirming therapies in Switzerland.
- Trial name
- SPECTRA (NCT06774053)
- Testing
- Group A (start of GAHT), Group B (on-going GAHT), Group C (GAS)
- Where
- 3 sites in Switzerland
- Volunteers
- 600 people
- Sponsor
- University Hospital, Basel, Switzerland
Headache, Migraine
Headache and Hormone Use Among Transgender Population in Thailand: A Cross-Sectional Online Study
The goal of this observational study is to learn how common headache and migraine are and to describe headache patterns among transgender adults in Thailand.
- Trial name
- H-TRANS (NCT07817446)
- Testing
- gender-affirming hormone therapy, Gender-Affirming Surgery, HIV Pre-Exposure Prophylaxis
- Where
- Thailand
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Chulalongkorn University
Gender Dysphoria, Gender Dysphoria, Adult
Metoidioplasty and Phalloplasty Surgery Decision Making
The goal of this clinical trial is to test a new online tool designed to provide clear and understandable information to help individuals considering Metoidioplasty and Phalloplasty Surgeries (MaPS) make informed decisions The…
- Conditions
- Gender Dysphoria, Gender Dysphoria, Adult, Gender Incongruence, Transgenderism
- Trial name
- MaPS (NCT06565663)
- Testing
- MaPS Decision Aid
- Where
- 2 sites in United States
- Volunteers
- 140 people
- Sponsor
- Dartmouth-Hitchcock Medical Center