Phase 2 Rare Disease Trial, Not Yet Recruiting NCT07041814 Sponsor: Universiti Kebangsaan Malaysia Medical Centre Condition: Rare Disease
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Phase 2 Rare Disease Trial, Not Yet Recruiting

NCT07041814
Not Yet Recruiting Phase 2

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • Females aged 11 to 30 years old who have been diagnosed with Turner's syndrome, confirmed by chromosome testing (showing a 45,X pattern or similar) and by a doctor's clinical assessment, before puberty has been started with treatment.
  • People whose bodies are not producing enough estrogen due to ovarian failure, confirmed by a specific blood test showing a high FSH level (above 25 IU/L).
  • People who have not yet gone through puberty, meaning no breast development has occurred and the uterus remains underdeveloped.
  • People who have never previously been treated with Hormone Replacement Therapy (HRT).
  • People whose breast development is at an early stage (Tanner Stage 2 or lower), as assessed by a doctor.
  • People who are currently taking Growth Hormone (GH) treatment are permitted to participate.
  • People for whom proper consent has been given — by the individual themselves if aged 18 or over, or by a parent or guardian for those under 18, with the individual's own agreement also obtained.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who are already showing signs of puberty starting on its own, without treatment.
  • People who have a known allergy or medical reason why they cannot take the trial medications, based on the British National Formulary guidelines (BNF 85).
  • People who have previously been treated with estrogen at any point.
  • People currently taking medications that affect bone density, such as bisphosphonates or long-term steroid tablets (note: vitamin D supplements and short courses of steroids are permitted).
  • People who have an active or ongoing liver disease, whether sudden or long-term.
  • People who have an underactive thyroid that is currently not being treated.
  • People who have inflammatory bowel disease (such as Ulcerative Colitis or Crohn's disease) or coeliac disease.
  • People who smoke cigarettes.
  • People who are considered severely obese — for those aged 11 to 17, this means a BMI above the 95th percentile on the WHO growth chart; for those aged 18 to 30, this means a BMI of 37.5 or above, based on Malaysian clinical guidelines.
  • People who have unexplained or abnormal genital bleeding that has not been diagnosed.
  • People who have a condition called porphyria.
  • People who have taken part in another clinical research study testing a new HRT treatment within the past 6 months.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 17 August 2026

Contact this trial

Principal Investigator: MUHAMMAD IRFAN ABDUL JALAL, MBChB BAO, PhD, Universiti Kebangsaan Malaysia Medical Molecular Biology Institute (UMBI)

Phone: +60391455950

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Universiti Kebangsaan Malaysia Medical Centre
Registry
ClinicalTrials.gov
Start date
15 February 2026
Est. completion
30 April 2029

Where this trial is recruiting

🇲🇾 Malaysia

Primary endpoints

Proportions of Turner Syndrome with Satisfactory Breast Development (defined as Turner Breast Stage 3 (B3) and above); Median time to achieving Tanner Breast Stage 4 (B4) and above (in days); Uterine length (in cm); Anteroposterior uterine fundal diameter (in cm)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 17 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov