Genetic DisorderPhase 3NCT01710696
Induction of Puberty With 17-beta Estradiol in Girls With Turner Syndrome
A Phase 3 study testing 17-beta estradiol in people with Genetic Disorder and Turner Syndrome, run by Novo Nordisk A/S at 28 sites in Spain.
Trial summary
This trial is conducted in Europe. The aim of the trial is to induce normal pubertal development in girls with Turner Syndrome in accordance with that of their peers and their individual state psychosocial maturation. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Genetic Disorder, Turner Syndrome
- What is being tested?
- 17-beta estradiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 28 sitesSpain
- Study dates
- 23 Jul 1998to 26 Jul 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Turner Syndrome
- Treatment with growth hormone
- Bone age minimum 12 years and maximum 14 years
- Clear signs of ovarian insufficiency
- Well documented growth rate during the last 12 months
Who cannot join
- Signs of spontaneous puberty
- Known or suspected hypersensitivity to trial product
- Acute or chronic liver disease
- Previous treatment with estrogen
- Undiagnosed abnormal genital bleeding
- Known thyroid diseases not adeadequately treated
- Porphyria
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
Spain28 sites
Novo Nordisk Investigational Site
Alicante, 03010
Novo Nordisk Investigational Site
Badajoz, 06080
Novo Nordisk Investigational Site
Barakaldo, 48903
Novo Nordisk Investigational Site
Cáceres, 10002
Novo Nordisk Investigational Site
Córdoba, 14004
Novo Nordisk Investigational Site
El Palmar, 30120
Novo Nordisk Investigational Site
Elche, 3203
Novo Nordisk Investigational Site
Esplugues Llobregat, 08950
Novo Nordisk Investigational Site
Granada, 18012
Novo Nordisk Investigational Site
Jaén, 23007
Novo Nordisk Investigational Site
Las Palmas, 35016
Novo Nordisk Investigational Site
Madrid, 28007
Novo Nordisk Investigational Site
Madrid, 28009
Novo Nordisk Investigational Site
Madrid, 28034
Novo Nordisk Investigational Site
Madrid, 28040
Novo Nordisk Investigational Site
Madrid, 28041
Novo Nordisk Investigational Site
Madrid, 28046
Novo Nordisk Investigational Site
Málaga, 29011
Novo Nordisk Investigational Site
Salamanca, 37007
Novo Nordisk Investigational Site
San Cristóbal de La Laguna, 38320
Novo Nordisk Investigational Site
Santa Cruz de Tenerife, 38010
Novo Nordisk Investigational Site
Santander, 39008
Novo Nordisk Investigational Site
Santiago de Compostela, 15705
Novo Nordisk Investigational Site
Seville, 41013
Novo Nordisk Investigational Site
Tarrasa, 08227
Novo Nordisk Investigational Site
Valencia, 46026
Novo Nordisk Investigational Site
Valladolid, 47011
Novo Nordisk Investigational Site
Zaragoza, 50009
About this study
Official title: Induction of Puberty With 17-Beta Estradiol in Girls With Turner Syndrome. An Open Randomized Trial
This trial is conducted in Europe. The aim of the trial is to induce normal pubertal development in girls with Turner Syndrome in accordance with that of their peers and their individual state psychosocial maturation.
- Conditions
- Genetic Disorder, Turner Syndrome
- Being tested
- 17-beta estradiol
- Medical subject headings
- Genetic Diseases, Inborn, Turner Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17-beta estradiolDrug
5-15 mcg/kg daily for 2 years. Dose readjusted every 3 months. Administered orally
17-beta estradiolDrug
0.2 mcg daily for 12 months, dose escalated to 0.5 mcg daily for 12 months. Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Individual dose | Experimental | Not described Receives: Drug: 17-beta estradiol |
| Fixed dose | Experimental | Not described Receives: Drug: 17-beta estradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pubertal stage assesed by Tanner score
FSH (Follicle Stimulating Hormone) levels
Secondary outcomes (3)
Height velocity
Pubertal stage assessed by Tanner score: Breast, pubic hair, axillary hair
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2012 (estimated)
- Study start23 Jul 1998
- Primary completion26 Jul 2004
- Study completion26 Jul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic DisorderStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710696
- Sponsor's protocol ID
- GHTUR/E/2
- Status last verified
- Feb 2017
- First submitted
- 16 Oct 2012
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of Puberty With 17-Beta Estradiol in Girls With Turner Syndrome. An Open Randomized Trial
- ClinicalTrials.gov ID
- NCT01710696
- Acronym / sponsor ID
- GHTUR/E/2
- Conditions
- Genetic Disorder, Turner Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 1998 (actual)
- Primary completion
- 26 Jul 2004 (actual)
- Study completion
- 26 Jul 2004 (actual)
- First posted
- 19 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is conducted in Europe. The aim of the trial is to induce normal pubertal development in girls with Turner Syndrome in accordance with that of their peers and their individual state psychosocial maturation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual dose | Experimental | Drug: 17-beta estradiol |
| Fixed dose | Experimental | Drug: 17-beta estradiol |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Turner Syndrome
- Treatment with growth hormone
- Bone age minimum 12 years and maximum 14 years
- Clear signs of ovarian insufficiency
- Well documented growth rate during the last 12 months
Key exclusion criteria (7 listed)
- Signs of spontaneous puberty
- Known or suspected hypersensitivity to trial product
- Acute or chronic liver disease
- Previous treatment with estrogen
- Undiagnosed abnormal genital bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 17-beta estradiol5-15 mcg/kg daily for 2 years. Dose readjusted every 3 months. Administered orally | Drug | Individual dose |
| 17-beta estradiol0.2 mcg daily for 12 months, dose escalated to 0.5 mcg daily for 12 months. Administered orally | Drug | Fixed dose |
Primary outcome
Pubertal stage assesed by Tanner score
FSH (Follicle Stimulating Hormone) levels
3 secondary outcomes
Height velocity
Pubertal stage assessed by Tanner score: Breast, pubic hair, axillary hair
Adverse events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 17-beta estradiol in people with Genetic Disorder and Turner Syndrome, run by Novo Nordisk A/S at 28 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pubertal stage assesed by Tanner score. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.