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NCT06247267 · ClinicalTrials.gov registry record

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

A clinical trial of Hypogonadism and Gender Identity Dysphoria, sponsored by Walter Reed National Military Medical Center.

Recruiting
Registry status
75
Enrollment target
1
Study location

NCT06247267 is a study of Hypogonadism and Gender Identity Dysphoria that is actively recruiting participants, run by Walter Reed National Military Medical Center. The registered enrollment target is 75 participants, below the 117-participant average among 21 other Hypogonadism trials with a reported enrollment target (36% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06247267, a study of Hypogonadism and Gender Identity Dysphoria, is actively recruiting participants, sponsored by Walter Reed National Military Medical Center.

RECRUITING
Registry status
75 participants
Enrollment target
1
Study location

Study Summary

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.

Interventions

  • DRUG Estradiol
  • DRUG Fortesta

Study Locations (1)

Maryland

  • Walter Reed National Military Medical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2021-03-09
Est. Completion 2025-08

What the Registry Record Tells You About NCT06247267

The ClinicalTrials.gov registry entry for NCT06247267 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 117-participant average among 21 other Hypogonadism trials with a reported enrollment target (36% lower). The listed sponsor is Walter Reed National Military Medical Center, which has 48 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Hypogonadism appearing as the primary indexed condition, and to 2 interventions - of which Estradiol is the first listed.

NCT06247267 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT06247267 about?

NCT06247267 is a clinical study titled "The Effect of Sex Steroid Replacement Therapy in the Hypogonadism and Transgender Active-Duty Population". 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 experienc...

What is the current status of trial NCT06247267?

This trial is currently recruiting. The enrollment target is 75 participants. The study started on 2021-03-09. Estimated completion is 2025-08.

What conditions does trial NCT06247267 study?

This clinical trial studies the following conditions: Hypogonadism, Gender Identity Dysphoria.

What interventions are being tested in trial NCT06247267?

The interventions under investigation include: Estradiol (DRUG), Fortesta (DRUG).

Who is sponsoring clinical trial NCT06247267?

This trial is sponsored by Walter Reed National Military Medical Center, which has 48 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06247267 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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