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Not yet taking people in United StatesPhase 2

Low-dose estradiol skin patches for girls with Turner syndrome before puberty

Tests the safety of estradiol patches in girls with Turner syndrome and ovarian failure.

Key facts

Who runs it
Children's National Research Institute
Where
Washington D.C., United StatesSee the site
Trial code
Registry title
Pre-pubertal Low Dose Transdermal Estradiol in Turner Syndrome
Status
Not yet recruiting
Phase
Phase 2
People taking part
15 people, planned
Started
1 Sept 2026
Expected to end
Jun 2027
Type of study
Interventional
Treatments tested
  • Estradiol transdermal patch 0.025mg/24 hours- 1/8th fractionated patch
Record updated
25 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for girls aged 8 to 11 years and 180 days with Turner syndrome whose ovaries do not work. It tests whether ultra-low dose estradiol skin patches are safe and help working speed and short-term memory.

Age
8 years up to 11 years and 180 days
Sex
Girls only
Disease stage
Turner syndrome confirmed by a chromosome test (karyotype), with ovarian failure (primary ovarian insufficiency). No breast development at Tanner stage 3 or more and no periods on their own.
Earlier treatment
Must not have had estrogen before.
Biomarker or test result
At least one FSH result > 10 mIU/mL in the past 12 months.

Main reasons for not taking part

  • Breast development to Tanner stage 3 or more, periods on their own, or abnormal uterine bleeding
  • Any earlier estrogen treatment
  • Y-chromosome material, unless the gonads were removed and the outer genitals are fully female
  • Any cancer in the past, or a known clotting disorder or deep vein clot
  • Untreated low thyroid or celiac disease, or memory and thinking problems too severe to do the tests

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Female, aged 8 years up to 11 y and 180 days with karyotype confirmed Turner syndrome
  • FSH result> 10miu/mL in the past 12 months. Since variability in FSH is not uncommon, a single measure of FSH >10mIU/mL in the past calendar year will be deemed sufficient for inclusion into the study even if repeat measures may be under 10mIU/mL
  • Ability to take the transdermal estradiol medication and be willing to adhere to the treatment regimen
  • Ability to complete the primary endpoint testing in English. Non-English speakers may be recruited if the participant is capable of performing the English version of the tests

Who cannot take part

  • Previous estrogen exposure
  • Spontaneous thelarche with breast Tanner stage 3 or more, spontaneous menarche or history of abnormal uterine bleeding
  • Cognitive impairment is severe enough to prevent assessment of the primary outcome measures
  • Untreated hypothyroidism or celiac disease: Individuals may be recruited if on treatment and stable medication dose in past 3 months
  • History of any type of malignancy
  • History of a known clotting disorder/deep venous thrombosis
  • Subjects known to have Y-chromosome material unless they have undergone gonadectomy and have fully external female genitalia
  • Any clinically significant abnormality as determined by the principal investigator

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 8 and 12 years old?

Where in United States

  • Children's National HospitalWashington D.C., United StatesContact: Kimberly Pitner, MSHS, BSN, RNNot yet recruiting

About the trial

What the trial wants to find out

This is a research study to find out if treatment with transdermal estradiol patches started between 8 to 11.5 years is safe in girls with Turner syndrome who have ovarian failure and to see whether it may improve performance on two tests of working speed and short-term memory.

The group in the trial

  • Estradiol TreatmentTreatment being tested

    Patients opt to receive 6 months of transdermal ultra low dose estradiol treatment

    Treatment: Estradiol transdermal patch 0.025mg/24 hours- 1/8th fractionated patch

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Ultra-low Dose Transdermal Estradiol Therapy in Prepubertal Girls With Turner Syndrome and Primary Ovarian Insufficiency.
Plain-language title
Low-dose estradiol skin patches for girls with Turner syndrome before pubertyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT07784582, who can take part
Record updated
25 August 2026