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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ovarian Failure, Premature

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vivelle-Dot

17Beta Estradiol - transdermal

Group Type ACTIVE_COMPARATOR

17Beta Estradiol - transdermal

Intervention Type DRUG

Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months

Progesterone, micronized

Intervention Type DRUG

Given starting at 18 months

Premarin

Conjugated estrogens

Group Type ACTIVE_COMPARATOR

Conjugated estrogens

Intervention Type DRUG

Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months

Progesterone, micronized

Intervention Type DRUG

Given starting at 18 months

Estrace

17beta Estradiol

Group Type ACTIVE_COMPARATOR

17beta Estradiol

Intervention Type DRUG

Oral pill given daily at increasing doses every 6 months for 18 months.

Progesterone, micronized

Intervention Type DRUG

Given starting at 18 months

Interventions

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17beta Estradiol

Oral pill given daily at increasing doses every 6 months for 18 months.

Intervention Type DRUG

Conjugated estrogens

Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months

Intervention Type DRUG

17Beta Estradiol - transdermal

Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months

Intervention Type DRUG

Progesterone, micronized

Given starting at 18 months

Intervention Type DRUG

Other Intervention Names

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Estrace Premarin Vivelle-Dot Prometrium

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No