Treatment for Transgenderism

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Washington University Transgender Center, Saint Louis, MO
Transgenderism
Eligibility
18 - 65
Male
Eligible conditions
Select

Study Summary

This study is evaluating whether estrogen use is safe and effective for transgender women.

See full description

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 4 secondary outcomes in patients with Transgenderism. Measurement will happen over the course of Changes from baseline lipid panel at 12 and 24 months.

Month 24
Homeostatic Model Assessment for Insulin Resistance
Month 24
Coagulation factors II, IX, XI, Protein C, Protein S, von Willebrand factor, and activated protein C resistance in transgender female patients undergoing
Month 24
Degree of testosterone suppression by measuring total testosterone level in transgender female patients undergoing hormonal affirming therapy
Month 24
von Willebrand factor in transgender female patients undergoing
Month 24
Llipid panel

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

Daily sublingual estradiol plus spironolactone
1 of 3
Transdermal estradiol plus spironolactone
1 of 3
Twice daily sublingual estradiol plus spironolactone
1 of 3
Active Control

This trial requires 45 total participants across 3 different treatment groups

This trial involves 3 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Daily sublingual estradiol plus spironolactoneStarting dose will be 2 mg daily Plan to increase every month by 2 mg daily Goal is to achieve serum estradiol level between 100-200 pg/mL mL and to suppress testosterone to cisgender female levels. All patients will also receive spironolactone. Spironolactone will be started at 50 mg daily and will increase to standard dose. Spironolactone will be started at 50 mg daily and will increase to standard dose.
Transdermal estradiol plus spironolactoneStarting dose will be 100 mcg/24hrs Plan to increase by 100 mcg/24hrs every month to a max dose of 400 mcg/24hrs Goal is to achieve a serum estradiol level between 100-200 pg/mL and to suppress testosterone to cisgender female levels All patients will also receive spironolactone. Spironolactone will be started at 50 mg daily and will increase to standard dose.
Twice daily sublingual estradiol plus spironolactoneStarting dose will be 1 mg twice daily Plan to increase every month by 2 mg daily divided BID Goal is to achieve serum estradiol level between 100-200 pg/mL mL and to suppress testosterone to cisgender female levels All patients will also receive spironolactone. Spironolactone will be started at 50 mg daily and will increase to standard dose. Spironolactone will be started at 50 mg daily and will increase to standard dose.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline total testosterone level at 6,12,18, and 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly change from baseline total testosterone level at 6,12,18, and 24 months for reporting.

Who is running the study

Principal Investigator
G. E. N.
Prof. Ginger E Nicol, Associate Professor of Child & Adolescent Psychiatry
Washington University School of Medicine

Closest Location

Washington University Transgender Center - Saint Louis, MO

Eligibility Criteria

This trial is for male patients between 18 and 65 years old. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Female transgender patients between the ages of 18 to 30 years of age who are seen at the Washington University Transgender Center. Patients must have met the eligibility and readiness criteria for gender-affirming hormone therapy.

Patient Q&A Section

What is the average age someone gets transgenderism?

"The average age [of people who were] transgender [is] 23 years, but varies across jurisdictions. This should be taken into account when evaluating the outcomes of trans rights or transgender identity." - Anonymous Online Contributor

Unverified Answer

What causes transgenderism?

"Transsexuality is not an inherent characteristic of the underlying neural basis of transsexualism. Rather, the transition from sex to gender appears to be a product, probably secondary, of the interaction of environmental, psychological, hormonal and physical factors that have evolved to create a sense of sexual identity and gender variance." - Anonymous Online Contributor

Unverified Answer

What are common treatments for transgenderism?

"Current research on treatments for [transgender](https://www.withpower.com/clinical-trials/transgender)ism is scarce. Treatment options are limited because most therapies are based on assumptions that the effects on the psychological well being of trans-identified males are similar to those for cis-identified men, regardless of the person's current body gender. Therefore, clinicians must make specific decisions based upon the needs of the patient instead of assumptions. The lack of research evaluating existing treatments may be due to the absence of a standardized treatment programme for transgenderism and/or it may be that the treatments used are poorly-designed randomised studies. However, in the light of the lack of evidence that treatment has any effect on quality of life, there is an ethical issue about whether there is enough benefit to justify treatment." - Anonymous Online Contributor

Unverified Answer

What is transgenderism?

"For most [transgender](https://www.withpower.com/clinical-trials/transgender) people, there is no need to fear developing trans-specific cancers. Many do develop breast cancer and some develop ovarian cancer. However, most trans women do not develop breast cancer, and those who do are unlikely to die of cancer, or from its effects. A higher cancer rate than cisgender women with similar age and BMI has been reported, possibly indicating some differences in the immune cells." - Anonymous Online Contributor

Unverified Answer

How many people get transgenderism a year in the United States?

"It is estimated that there are approximately 0.9% of Americans who have a transsexual experience. The prevalence is thought to be higher due to incomplete reporting of incidences and the fact that many people do not report their experiences completely." - Anonymous Online Contributor

Unverified Answer

What are the signs of transgenderism?

"Early signs of transgenderism include poor appetite, increased appetite and weight gain, and excessive hair growth in males, especially in the back of the head, on the sides of the face, and on the legs. The appearance of the phallus is one of the most readily noticeable changes caused by transformation. These early signs continue as puberty occurs, especially in women, who may also develop breasts and/or breasts enlargement. Increased body hair growth on the head or back of the shoulders may be the first physical indication in males of this development of an atypical body image. The earliest sign of depression is an increase in anhedonia, or a loss of pleasure as a result of a decrease in stimulation." - Anonymous Online Contributor

Unverified Answer

Does treatment improve quality of life for those with transgenderism?

"Treating (corrective/preventive) [transgender](https://www.withpower.com/clinical-trials/transgender)ism with testosterone or other hormones at or above the normal range is associated with significant quality-of-life improvement. Although it may not be possible in all clinics, these preliminary data suggest that transgender patients may benefit from hormone therapy for treatment of (corrective/preventive) medical problems, as these patients can experience improvements in social and physical function, and lower rates of morbidity and mortality." - Anonymous Online Contributor

Unverified Answer

How does treatment work?

"The current model for evaluating the effectiveness of treatments may be inadequate given the prevalence of treatments administered in clinical trials; there is also an inverse relationship between the likelihood of trial publication and the efficacy of the treatment. Therefore, cancer clinical trials should: 1.) include only the most effective treatments available; 2.) compare the most effective treatments and combinations of treatments; and 3.) be published as quickly and in as many outlets as possible to allow patients to evaluate and adopt these new therapeutic options." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in treatment for therapeutic use?

"There were many improvements in the treatment of acne including the invention of modern antibiotics, in particular tetracycline antibiotics such as minocycline. These, with increased use of topical corticosteroids, including mometasone furoate, are increasingly used to treat acne. This has changed the treatment of acne from one of oral therapy alone with antibiotics to one which uses a combination of oral and topical agents, such as oral antibiotics and antibioactive eye drops. There are multiple ongoing clinical trials addressing this issue. However, treatment with oral antibiotics alone is still the most common treatment." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating transgenderism?

"It may be worthwhile to consider several new possibilities for treating transgressive or intersex conditions. The first two options, gender transformation through sex reassignment and surgical surgical intervention to alter the anatomy of the internal organs, would be the easiest to perform and the least expensive, so they should not be ignored. The other possible options are hormone therapy and palliative procedures for some conditions, such as intersex disease that cannot be cured." - Anonymous Online Contributor

Unverified Answer

What does treatment usually treat?

"Untreated gender dysphoria results in significant distress, shame, and shame avoidance. The high rate of untreated gender dysphoria suggests that there is a need for more treatment options to provide better outcomes. Although initial treatment is usually used for transition-related distress, many young adults with gender dysphoria remain unmedicated long after completing trans-related treatment. Results from a recent clinical trial of the current study highlight the importance of incorporating treatment for gender dysphoria in transition treatment protocols. More patients with gender dysphoria should know that transitioning therapy can be effective in reducing distress and improving physical well-being." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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