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Estrogen showdown: gel or pill for turner syndrome puberty?

NCT ID NCT07041814

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This trial tests two ways of giving estrogen to girls and young women with Turner syndrome to help them start puberty. Participants will be randomly assigned to use either an estrogen gel applied to the skin or an estrogen tablet taken by mouth for 19 months. The study will compare breast development, uterine growth, and side effects to see which method works better.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
estrogen (estradiol valerate tablets or estradiol gel)
What this could lead to
If successful, this trial could show which estrogen method (gel or tablet) is more effective and safer for starting puberty in girls with Turner syndrome, helping doctors choose the best treatment.
What could go wrong
This is a small early-phase trial with only 24 participants, so results may not apply to everyone. Both treatments are already used, so no major new risks are expected, but side effects like headaches or nausea are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

11 to 30 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Females aged 11-30 years old with karyotype-verified (45, X or other similar karyotypes) and clinically confirmed Turner's syndrome prior at the time of pubertal induction 2. Confirmed estrogen deficiency with primary ovarian failure (high level of follicular stimulating hormone (FSH \> 25 IU/L)) 3. Patients who have not undergone pubertal development ( no breast development and underdeveloped uterus size). 4. Hormone Replacement Therapy (HRT)-naive TS patients 5. Breast Tanner Stage of 2 or less. 6. Patients on Growth Hormone (GH) will be allowed entry into the study. 7. Consented to trial participation (from individual TS patients (if aged 18 and above) or the parents or guardians (for under-18 TS patients) with individual's assent Exclusion Criteria: 1. Patients with signs of spontaneous puberty 2. Contraindications to trial products (e.g hypersensitivity to any components of the HRT) based on the most recent version of the British National Formulary (BNF 85) 3. Previous history of exposure to estrogen treatment. 4. Concomitant use of other drugs that affect the bone mineral density (BMD) of the participants (e.g. Bisphosphonates or prolonged use of systemic corticosteroids). Vitamin D supplementation and short corticosteroid usage are allowed. 5. Acute or chronic hepatic disease 6. Patients with untreated hypothyroidism 7. Inflammatory bowel disease (Ulcerative Colitis, Crohn's disease) and coeliac disease 8. Cigarette-smoking patients 9. Severely obese patients based on the following criteria: 1. For TS patients aged 11-17 years old: Based on the WHO chart with BMI \> 95th percentile 2. For TS patients aged 18 years until 30 years: BMI of 37.5 or above based on the Malaysian Clinical Practice Guideline for the Management of Obesity 10. Unknown abnormal genital bleeding 11. Porphyria 12. Recent involvement with clinical research studies (previous 6 months) investigating new HRT formulations

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Canselor Tuanku Muhriz (HCTM)

    Cheras, Kuala Lumpur, 56000, Malaysia

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