CClinicalTrials.gg
CompletedNCT01710696Updated Feb 28, 2017

Induction of Puberty With 17-beta Estradiol in Girls With Turner Syndrome

A Phase 3 interventional study of 17-beta estradiol and 17-beta estradiol in Genetic Disorder and Turner Syndrome, sponsored by Novo Nordisk A/S. Completed at 28 sites in Spain. Open to female participants. Per ClinicalTrials.gov, last updated 2017-02-28.

Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 14 years 2 months after the study started (first participant enrolled Jul 1998, registered Oct 2012).
Phase
Phase 3
Study type
Interventional
Enrollment
50
Allocation
Randomized
Sex
Female
01

Study 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.

02

Conditions studied

03

In context

Turner Syndrome

115 studies on the registry are indexed under Turner Syndrome; 33 are open to participants now.

This study's enrollment of 50 is below the median of 65 across 51 interventional studies indexed under Turner Syndrome.

Browse Turner Syndrome studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Individual dose

    Drug: 17-beta estradiol

  • Experimental
    Fixed dose

    Drug: 17-beta estradiol

Interventions

  • Drug17-beta estradiol

    5-15 mcg/kg daily for 2 years. Dose readjusted every 3 months. Administered orally

  • Drug17-beta estradiol

    0.2 mcg daily for 12 months, dose escalated to 0.5 mcg daily for 12 months. Administered orally

06

What researchers measure

Primary outcomes

  1. Pubertal stage assesed by Tanner score

  2. FSH (Follicle Stimulating Hormone) levels

Secondary outcomes

  1. Height velocity

  2. Pubertal stage assessed by Tanner score: Breast, pubic hair, axillary hair

  3. Adverse events

07

Study locations

28 sites
  • Novo Nordisk Investigational Site
    Alicante, 03010, Spain
  • Novo Nordisk Investigational Site
    Badajoz, 06080, Spain
  • Novo Nordisk Investigational Site
    Baracaldo, 48903, Spain
  • Novo Nordisk Investigational Site
    Cáceres, 10002, Spain
  • Novo Nordisk Investigational Site
    Córdoba, 14004, Spain
  • Novo Nordisk Investigational Site
    El Palmar, 30120, Spain
  • Novo Nordisk Investigational Site
    Elche, 3203, Spain
  • Novo Nordisk Investigational Site
    Esplugues Llobregat, 08950, Spain
  • Novo Nordisk Investigational Site
    Granada, 18012, Spain
  • Novo Nordisk Investigational Site
    Jaén, 23007, Spain
  • Novo Nordisk Investigational Site
    La Laguna, 38320, Spain
  • Novo Nordisk Investigational Site
    Las Palmas, 35016, Spain
  • Novo Nordisk Investigational Site
    Madrid, 28007, Spain
  • Novo Nordisk Investigational Site
    Madrid, 28009, Spain
  • Novo Nordisk Investigational Site
    Madrid, 28034, Spain
  • Novo Nordisk Investigational Site
    Madrid, 28040, Spain
  • Novo Nordisk Investigational Site
    Madrid, 28041, Spain
  • Novo Nordisk Investigational Site
    Madrid, 28046, Spain
  • Novo Nordisk Investigational Site
    Málaga, 29011, Spain
  • Novo Nordisk Investigational Site
    Salamanca, 37007, Spain
  • Novo Nordisk Investigational Site
    Santa Cruz de Tenerife, 38010, Spain
  • Novo Nordisk Investigational Site
    Santander, 39008, Spain
  • Novo Nordisk Investigational Site
    Santiago de Compostela, 15705, Spain
  • Novo Nordisk Investigational Site
    Sevilla, 41013, Spain
  • Novo Nordisk Investigational Site
    Tarrasa, 08227, Spain
  • Novo Nordisk Investigational Site
    Valencia, 46026, Spain
  • Novo Nordisk Investigational Site
    Valladolid, 47011, Spain
  • Novo Nordisk Investigational Site
    Zaragoza, 50009, Spain
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01710696
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Oct 19, 2012
Start date
Jul 23, 1998
Primary completion
Jul 26, 2004
Completion
Jul 26, 2004
Last update
Feb 28, 2017

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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