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Androgen Receptor, Implications for Health and Wellbeing: Natural History Study of Individuals With Androgen Insensitivity

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 290 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor 6 versions Re-verified since Jun 24, 2026, no change to tracked fieldsv285-v290
  2. Minor Eligibility criteria revised
    • Study description revised
    v284
  3. Minor 6 versions Re-verified since Sep 13, 2025, no change to tracked fieldsv278-v283
  4. Minor Secondary endpoints: details revised at 1 of 5 entriesv277
  5. Minor Study description expanded, about 12 wordsv276
Show 35 earlier versionsHide 35 earlier versions
  1. Minor 11 versions Re-verified since Nov 2, 2024, no change to tracked fieldsv265-v275
  2. Minor Eligibility criteria shortened, about 89 words
    • Study description expanded, about 24 words
    v264
  3. Minor 2 versions Re-verified since Oct 10, 2024, no change to tracked fieldsv262-v263
  4. Minor Eligibility criteria revised
    • Study description expanded, about 17 words
    v261
  5. Minor 8 versions Re-verified since Jul 12, 2024, no change to tracked fieldsv253-v260
  6. Minor Study description expanded, about 181 wordsv252
  7. Minor 6 versions Re-verified since Sep 20, 2023, no change to tracked fieldsv246-v251
  8. Minor Eligibility criteria expanded, about 43 wordsv245
  9. Minor 4 versions Re-verified since May 20, 2023, no change to tracked fieldsv241-v244
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: Androgen effects in humans are usually (but not always) mediated by the androgen receptor which is coded for by the androgen receptor gene (AR gene). Androgen Insensitivity Syndrome (AIS) is a rare condition in which the body cannot sense the male hormones in the blood or tissue. Both women and men can be affected by AIS. Researchers want to learn more about the health of people with AIS over time. With a natural history study in individuals with AIS, data and tests may provide information regarding health risks (including the risks and benefits of gonadectomy and best ways to monitor for tumor) and optimal management of individuals with AIS as well as elucidate the role of the androgen receptor in human health. This study does not involve any interventions and we can provide clinical care while collecting data. Objective: The objective of this natural history study is to describe and define a comprehensive phenotype (characteristic) of patients with AIS based on confirmed androgen receptor (AR) gene difference. We will evaluate hormones, bone density and markers, cardiovascular and metabolic parameters, as well as quality of life and tumor formation risk and evaluation. The purpose is to obtain a better understanding of the overall health issues that people with AIS may have through the study procedures listed. Eligibility: People ages 8-99 with AIS and their adult relatives Design: Participants will go through a series of study procedures for data and specimen collection. This will be done to understand how AIS affects individuals since the androgen receptor is found in many tissues in the body including skin, bone, muscle, and the neurologic, immune and metabolic systems. All tests will be performed by skilled and trained study professionals. Participants will be screened with: Medical history Physical exam Medical record review Lab tests. Participants will have physical exams. Their body measurements will be taken. They will have blood and urine tests. They will have electrocardiograms to check heart health. They may complete questionnaires. They may have an Oral Glucose Tolerance Test. Participants may have x-rays and HRpQCT scans taken of the hand, wrist, and other bones. Participants will have body scans to measure bone thickness. Participants will have magnetic resonance imaging (MRI) or sonogram of the pelvis. For MRI, they may get a contrast agent via intravenous (IV) catheter. Adult participants may have the following: MR elastography. It uses MRI and low-frequency vibrations to map stiffness of body tissues. MR spectroscopy. It uses MRI to take pictures of chemicals in the liver and body fat. Cardiac computed tomography scan. It uses x-rays to make pictures of the heart. Participants may get a contrast agent via IV. Optional genital exam. Optional one-time vaginal swab. Participants will have visits every 1-2 years. Participation lasts indefinitely. Adult relatives will also be invited to participate but will have only 1 visit. It will include some of the above tests.
Trial Details
NCT Number NCT04708431
Lead Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)
Androgen Insensitivity Syndrome, Metabolic Parameters in AIS, CAIS, PAIS and MAIS, Tumor Formation in AIS, CAIS, PAIS and MAIS, Sexual Function AIS, CAIS, PAIS and MAIS
Related terms Androgen-Insensitivity Syndrome, Bulbo-Spinal Atrophy, X-Linked
Enrollment 650 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov