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Comparison of Transdermal and Oral Estrogens in Adolescent Girls With Ovarian Failure

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ClinicalTrials.gov Identifier: NCT01023178
Recruitment Status : Completed
First Posted : December 2, 2009
Results First Posted : January 20, 2017
Last Update Posted : January 20, 2017
Sponsor:
Information provided by (Responsible Party):
Darrell M Wilson, Stanford University

Tracking Information
First Submitted Date  ICMJE November 30, 2009
First Posted Date  ICMJE December 2, 2009
Results First Submitted Date  ICMJE July 16, 2014
Results First Posted Date  ICMJE January 20, 2017
Last Update Posted Date January 20, 2017
Study Start Date  ICMJE February 2007
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2016)
Estradiol [ Time Frame: end of study (up to 2 years) ]
Estradiol blood levels at end of study compared across groups to determine effect of dosing methods. Significance of levels depends on the stage of puberty and goals of therapy.
Original Primary Outcome Measures  ICMJE
 (submitted: November 30, 2009)
biologic markers [ Time Frame: 2 years ]
Change History Complete list of historical versions of study NCT01023178 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2009)
  • growth [ Time Frame: 2 years ]
  • feminization [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Transdermal and Oral Estrogens in Adolescent Girls With Ovarian Failure
Official Title  ICMJE Comparison of Transdermal and Oral Estrogens in Adolescents With Ovarian Failure
Brief Summary To directly compare the safety (by laboratory evaluation) and efficacy (feminization and growth) of three commonly used estrogen preparations in adolescent patients with ovarian failure, either due to congenital causes (Turner syndrome) or medical therapies. We hypothesize that transdermal estrogen will have equivalent efficacy and a more favorable safety profile in comparison with conventional oral estrogen replacement.
Detailed Description Treatment with transdermal 17beta(17β) estradiol resulted in higher estradiol levels and more effective feminization compared to oral conjugated equine estrogen but did not result in an otherwise different biochemical profile in this limited number of heterogeneous patients. OBE (oral beta estradiol) and TBE (transdermal beta estradiol) provide safe and effective alternatives to OCEE (oral conjugated equine estrogen) to induce puberty in girls, but larger prospective randomized trials are required.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Failure, Premature
Intervention  ICMJE
  • Drug: 17beta Estradiol
    Oral pill given daily at increasing doses every 6 months for 18 months.
    Other Name: Estrace
  • Drug: Conjugated estrogens
    Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months
    Other Name: Premarin
  • Drug: 17Beta Estradiol - transdermal
    Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months
    Other Name: Vivelle-Dot
  • Drug: Progesterone, micronized
    Given starting at 18 months
    Other Name: Prometrium
Study Arms  ICMJE
  • Active Comparator: Vivelle-Dot
    17Beta Estradiol - transdermal
    Interventions:
    • Drug: 17Beta Estradiol - transdermal
    • Drug: Progesterone, micronized
  • Active Comparator: Premarin
    Conjugated estrogens
    Interventions:
    • Drug: Conjugated estrogens
    • Drug: Progesterone, micronized
  • Active Comparator: Estrace
    17beta Estradiol
    Interventions:
    • Drug: 17beta Estradiol
    • Drug: Progesterone, micronized
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2013)
20
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2009)
60
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: in whom initiation of estrogen therapy has been recommended due to ovarian failure

  • Outpatients
  • age >=12 years to 17.99 years old

Exclusion Criteria:

  • spontaneous menses
  • significant concurrent medical problem including:
  • Liver function tests (LFTs) 3 times normal
  • clotting disorder
  • ongoing cancer treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01023178
Other Study ID Numbers  ICMJE SU-10272009-4262
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Darrell M Wilson, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Darrell M Wilson Stanford University
Study Director: E Kirk Neely Stanford University
Sub-Investigator: Sejal Shah Stanford University
PRS Account Stanford University
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP