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Trial record 10 of 29 for:    "Turner Syndrome" | "Estrogens"

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

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.

Condition or disease Intervention/treatment Phase
Ovarian Failure, Premature Drug: 17beta Estradiol Drug: Conjugated estrogens Drug: 17Beta Estradiol - transdermal Drug: Progesterone, micronized Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Transdermal and Oral Estrogens in Adolescents With Ovarian Failure
Study Start Date : February 2007
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013


Arm Intervention/treatment
Active Comparator: Vivelle-Dot
17Beta Estradiol - transdermal
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

Active Comparator: Premarin
Conjugated estrogens
Drug: Conjugated estrogens
Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months
Other Name: Premarin

Drug: Progesterone, micronized
Given starting at 18 months
Other Name: Prometrium

Active Comparator: Estrace
17beta Estradiol
Drug: 17beta Estradiol
Oral pill given daily at increasing doses every 6 months for 18 months.
Other Name: Estrace

Drug: Progesterone, micronized
Given starting at 18 months
Other Name: Prometrium




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01023178


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Darrell M Wilson Stanford University
Study Director: E Kirk Neely Stanford University
Sub-Investigator: Sejal Shah Stanford University

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Responsible Party: Darrell M Wilson, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01023178     History of Changes
Other Study ID Numbers: SU-10272009-4262
First Posted: December 2, 2009    Key Record Dates
Results First Posted: January 20, 2017
Last Update Posted: January 20, 2017
Last Verified: November 2016

Additional relevant MeSH terms:
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Primary Ovarian Insufficiency
Estrogens
Estrogens, Conjugated (USP)
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Estradiol
Polyestradiol phosphate
Progesterone
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Progestins