NCT01023178

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

January 20, 2017

Completed
Last Updated

January 20, 2017

Status Verified

November 1, 2016

Enrollment Period

6.3 years

First QC Date

November 30, 2009

Results QC Date

July 16, 2014

Last Update Submit

November 28, 2016

Conditions

Ovarian Failure, Premature

Outcome Measures

Primary Outcomes (1)

  • 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.

    end of study (up to 2 years)

Study Arms (3)

Vivelle-Dot

ACTIVE COMPARATOR

17Beta Estradiol - transdermal

Drug: 17Beta Estradiol - transdermalDrug: Progesterone, micronized

Premarin

ACTIVE COMPARATOR

Conjugated estrogens

Drug: Conjugated estrogensDrug: Progesterone, micronized

Estrace

ACTIVE COMPARATOR

17beta Estradiol

Drug: 17beta EstradiolDrug: Progesterone, micronized

Interventions

17beta EstradiolDRUG

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

Also known as: Estrace
Estrace
Conjugated estrogensDRUG

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

Also known as: Premarin
Premarin
17Beta Estradiol - transdermalDRUG

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

Also known as: Vivelle-Dot
Vivelle-Dot
Progesterone, micronizedDRUG

Given starting at 18 months

Also known as: Prometrium
EstracePremarinVivelle-Dot

Eligibility Criteria

Age12 Years - 18 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Outpatients
  • age \>=12 years to 17.99 years old

You may not qualify if:

  • spontaneous menses
  • significant concurrent medical problem including:
  • Liver function tests (LFTs) 3 times normal
  • clotting disorder
  • ongoing cancer treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

  • 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.

    PMID: 24982681DERIVED

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Interventions

EstradiolEstrogens, Conjugated (USP)Progesterone

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPregnenedionesPregnenesPregnanesCorpus Luteum HormonesProgesterone Congeners

Results Point of Contact

Title
Sejal Shah MD
Organization
Stanford University
sshah2@stanford.edu
6507235791

Study Officials

  • Darrell M Wilson

    Stanford University

    PRINCIPAL INVESTIGATOR

  • E Kirk Neely

    Stanford University

    STUDY DIRECTOR

  • Sejal Shah

    Stanford University

    SUB INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

November 30, 2009

First Posted

December 2, 2009

Study Start

February 1, 2007

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

January 20, 2017

Results First Posted

January 20, 2017

Record last verified: 2016-11

Locations

US(1)