search
Back to results

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

Primary Purpose

Ovarian Failure, Premature

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
17beta Estradiol
Conjugated estrogens
17Beta Estradiol - transdermal
Progesterone, micronized
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Failure, Premature

Eligibility Criteria

12 Years - 18 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Vivelle-Dot

Premarin

Estrace

Arm Description

17Beta Estradiol - transdermal

Conjugated estrogens

17beta Estradiol

Outcomes

Primary Outcome Measures

Estradiol
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.

Secondary Outcome Measures

Full Information

First Posted
November 30, 2009
Last Updated
November 28, 2016
Sponsor
Stanford University
search

1. Study Identification

Unique Protocol Identification Number
NCT01023178
Brief Title
Comparison of Transdermal and Oral Estrogens in Adolescent Girls With Ovarian Failure
Official Title
Comparison of Transdermal and Oral Estrogens in Adolescents With Ovarian Failure
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Failure, Premature

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vivelle-Dot
Arm Type
Active Comparator
Arm Description
17Beta Estradiol - transdermal
Arm Title
Premarin
Arm Type
Active Comparator
Arm Description
Conjugated estrogens
Arm Title
Estrace
Arm Type
Active Comparator
Arm Description
17beta Estradiol
Intervention Type
Drug
Intervention Name(s)
17beta Estradiol
Other Intervention Name(s)
Estrace
Intervention Description
Oral pill given daily at increasing doses every 6 months for 18 months.
Intervention Type
Drug
Intervention Name(s)
Conjugated estrogens
Other Intervention Name(s)
Premarin
Intervention Description
Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months
Intervention Type
Drug
Intervention Name(s)
17Beta Estradiol - transdermal
Other Intervention Name(s)
Vivelle-Dot
Intervention Description
Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months
Intervention Type
Drug
Intervention Name(s)
Progesterone, micronized
Other Intervention Name(s)
Prometrium
Intervention Description
Given starting at 18 months
Primary Outcome Measure Information:
Title
Estradiol
Description
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.
Time Frame
end of study (up to 2 years)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darrell M Wilson
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
E Kirk Neely
Organizational Affiliation
Stanford University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sejal Shah
Organizational Affiliation
Stanford University
Official's Role
Sub-Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24982681
Citation
Shah S, Forghani N, Durham E, Neely EK. A randomized trial of transdermal and oral estrogen therapy in adolescent girls with hypogonadism. Int J Pediatr Endocrinol. 2014;2014(1):12. doi: 10.1186/1687-9856-2014-12. Epub 2014 Jun 20.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs