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

Ovarian Failure, Premature Clinical Trial

Official title:

Comparison of Transdermal and Oral Estrogens in Adolescents With Ovarian Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01023178
• Other study ID #: SU-10272009-4262
• Secondary ID: 8225
• Status: Completed
• Phase: N/A
• First received: November 30, 2009
• Last updated: December 2, 2013
• Start date: February 2007
• Est. completion date: June 2013

Study information

• Verified date: December 2013
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years to 18 Years

Eligibility

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:

• LFTs 3 times normal

• clotting disorder

• ongoing cancer treatment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Failure, Premature
• Primary Ovarian Insufficiency

Intervention

Drug:
• 17beta Estradiol
Oral pill given daily at increasing doses every 6 months for 18 months.
• Conjugated estrogens
Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months
• 17Beta Estradiol - transdermal
Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months
• Progesterone, micronized
Given starting at 18 months

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	biologic markers		2 years	Yes
Secondary	growth		2 years	No
Secondary	feminization		2 years	No