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

Not Applicable

Completed

• Conditions: Ovarian Failure, Premature
• Interventions: Drug: 17Beta Estradiol - transdermal; Drug: 17beta Estradiol; Drug: Conjugated estrogens; Drug: Progesterone, micronized

• Registration Number: NCT01023178
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2009-11-30
• Study First Submitted QC: 2009-11-30
• Study First Posted: 2009-12-02
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Results First Submitted: 2014-07-16
• Status Verified: 2016-11
• Results First Submitted QC: 2016-11-28
• Last Update Submitted: 2016-11-28
• Results First Posted: 2017-01-20
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Premarin	Progesterone, micronized	Conjugated estrogens
Vivelle-Dot	17Beta Estradiol - transdermal	17Beta Estradiol - transdermal
Estrace	17beta Estradiol	17beta Estradiol
Vivelle-Dot	Progesterone, micronized	17Beta Estradiol - transdermal
Premarin	Conjugated estrogens	Conjugated estrogens
Estrace	Progesterone, micronized	17beta Estradiol

Primary Outcome Measures

Name	Time	Method
Estradiol	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.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States