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OpenTrials
Completed

NCT Number: NCT01023178

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

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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Key information

Conditions

Ovarian Failure, Premature Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Ovarian Diseases Primary Ovarian Insufficiency Urogenital Diseases

Age range

12 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

17beta Estradiol

Drug

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

Other names: Estrace

Conjugated estrogens

Drug

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

Other names: Premarin

17Beta Estradiol - transdermal

Drug

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

Other names: Vivelle-Dot

Progesterone, micronized

Drug

Given starting at 18 months

Other names: Prometrium

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Comparison of Transdermal and Oral Estrogens in Adolescents With Ovarian Failure

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Dec 2, 2009
Registry last updated
Jan 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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