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

Overview

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.

Full Title of Study: “Comparison of Transdermal and Oral Estrogens in Adolescents With Ovarian Failure”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2013

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.

Interventions

  • Drug: 17beta Estradiol
    • Oral pill given daily at increasing doses every 6 months for 18 months.
  • Drug: Conjugated estrogens
    • Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months
  • Drug: 17Beta Estradiol – transdermal
    • Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months
  • Drug: Progesterone, micronized
    • Given starting at 18 months

Arms, Groups and Cohorts

  • Active Comparator: Vivelle-Dot
    • 17Beta Estradiol – transdermal
  • Active Comparator: Premarin
    • Conjugated estrogens
  • Active Comparator: Estrace
    • 17beta Estradiol

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 12 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Stanford University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Darrell M Wilson, Principle Investigator – Stanford University
  • Overall Official(s)
    • Darrell M Wilson, Principal Investigator, Stanford University
    • E Kirk Neely, Study Director, Stanford University
    • Sejal Shah, Sub-Investigator, Stanford University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.