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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: Recruiting study of Hypogonadism and Gender Identity Dysphoria, sponsored by Walter Reed National Military Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Subjects will undergo Dual energy X-ray Absorptiometry conducted by the research coordinator assessing bone density, body composition, and risk of fractures.
Conditions Studied
Interventions
- DRUG Estradiol
- DRUG Fortesta
Study Locations (1)
Maryland
- Walter Reed National Military Medical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2021-03-09 |
| Est. Completion | 2025-08 |
What NCT06247267 shows while recruiting
NCT06247267 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 117-participant average among 21 other Hypogonadism trials with a reported enrollment target (36% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06247267's enrollment target sits among peer trials
75 9th of 21 higher than 12 of 21 other Hypogonadism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypogonadism trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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