NCT00224094

Brief Summary

This study compares the effects of 12 weeks of treatment with transdermal versus oral estrogen therapy on testsoterone levels and thyroid tests in healthy, naturally menopausal women.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

October 15, 2012

Status Verified

October 1, 2012

Enrollment Period

1.3 years

First QC Date

September 14, 2005

Last Update Submit

October 11, 2012

Conditions

Menopause

Keywords

MenopauseTestosteroneAndrogensSex Hormone Binding GlobulinThyroid functionCortisol

Outcome Measures

Primary Outcomes (1)

  • Compare the effects of a 12-week course of oral CEE to a 12-week course of transdermal estradiol on free testosterone concentrations in menopausal women.

    12 weeks

Secondary Outcomes (2)

  • Compare the effects of oral versus transdermal ERT on thyroid binding globulin concentrations and tests of thyroid function.

    12 weeks

  • Compare the effects of oral versus transdermal ERT on cortisol binding globulin and total and free cortisol concentrations.

    12 weeks

Study Arms (2)

Sequence A

EXPERIMENTAL

Oral ERT then transdermal ERT

Drug: Premarin® (oral) vs. Alora® (transdermal)

Sequence B

EXPERIMENTAL

Transdermal ERT then oral ERT

Drug: Premarin® (oral) vs. Alora® (transdermal)

Interventions

Premarin® (oral) vs. Alora® (transdermal)DRUG
Sequence ASequence B

Eligibility Criteria

Age42 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy
  • Naturally menopausal women
  • Aged 42-70 years
  • Currently using combination estrogen-progestin replacement therapy

You may not qualify if:

  • Women with contraindications to HRT use, including:Unexplained vaginal bleeding, liver disease, breast or endometrial cancer, venous thromboembolic events
  • Thyroid disease
  • Adrenal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Interventions

Estrogens, Conjugated (USP)Administration, Cutaneous

Intervention Hierarchy (Ancestors)

Estradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAdministration, TopicalDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Jan L Shifren, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

January 1, 2002

Primary Completion

May 1, 2003

Last Updated

October 15, 2012

Record last verified: 2012-10

Locations

US(1)