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

NCT01023178 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-01-20

Study results available
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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.

Conditions

  • Ovarian Failure, Premature

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

Sponsors & Collaborators

Principal Investigators

  • Darrell M Wilson · Stanford University

  • E Kirk Neely · Stanford University

  • Sejal Shah · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01023178 on ClinicalTrials.gov