NCT00547001

Brief Summary

This study will evaluate whether there is a difference in the proportion of women who report a worsening severity of their hot flashes between three tapering schedules for one accepted HT/ET regimen. Secondarily, we hope to evaluate whether there is a difference in the frequency (number of occurrences per week), severity (defined as a subjective scale mild, moderate, or severe), and "Severity Index" (SI, equaling the product of both) of hot flashes between three tapering schedules for one accepted HT/ET regimen.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
235

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2007

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

July 18, 2008

Status Verified

July 1, 2008

First QC Date

October 17, 2007

Last Update Submit

July 17, 2008

Conditions

Hot FlashesNight Sweats

Keywords

MenopauseHot flashesvasomotor symptomstapering regimenhormonal therapyOther menopausal symptoms including mood changes

Outcome Measures

Primary Outcomes (1)

  • To evaluate whether there is a difference in the proportion of women who report a worsening severity of their hot flashes between three tapering schedules for one accepted HT/ET regimen.

    During the tapering and post taper time period.

Secondary Outcomes (1)

  • frequency, severity, and "Severity Index" of hot flashes.

    During the tapering and post taper time period.

Study Arms (3)

1

ACTIVE COMPARATOR

Group A will be tapered over 4 weeks, starting at baseline (week 0). Subjects in this group will take one tablet of ET daily (effective dose, 0.75 mg) for week 1, then one 0.50 mg tablet daily for week 2, then one 0.25 mg tablet daily for week 3, and finally one 0.125 mg tablet daily for week 4.

Drug: Estradiol

2

PLACEBO COMPARATOR

Group B will be administered placebo. These tablets will appear identical to those administered to subjects in Group A, but the tablets will contain no estrogen. Subjects in this group will be instructed to take one pill every day for the 4 weeks. Thus, while patients will, in effect, be stopped abruptly from their therapy, there is still the potential of a placebo effect.

Drug: Estradiol

3

NO INTERVENTION

Group C will have their therapy discontinued acutely at baseline (week 0); i.e., these subjects will not take any tablets after the 8-week stabilization phase ends. While we recognize that this group will not be blinded to the regimen they are receiving, we feel that group C will be important to include in light of the consistent decrease in vasomotor symptoms experienced by women taking placebo. Because women taking placebo have approximately a 35% decrease in vasomotor symptoms, it will be important to compare our taper regimen to the "real life" scenario of stopping medication abruptly.

Drug: Estradiol

Interventions

EstradiolDRUG

1mg during stabilization \& then a taper to 0.75mg, 0.5mg, 0.25mg, 0.125mg.

123

Eligibility Criteria

Age35 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female.
  • ages 35-70, inclusive.
  • Postmenopausal (Natural or surgical: see definitions).
  • Currently on HT/ET for at least 6 months for vasomotor symptomatology.
  • Vasomotor symptoms are currently controlled on medication .
  • An annual physical \& pelvic exam has been performed within the last 12mo
  • The patient has had a normal mammogram(BIRADS I/II) within the last 24mo

You may not qualify if:

  • Males
  • Hypertension, defined as either SBP \>140 mmHg or DBP \>90 mmHg
  • Lack of compliance (willingness to adhere to protocol)
  • Inability or unwillingness to swallow pills
  • Patients with any contraindications to HT/ET

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06102, United States

RECRUITING

MeSH Terms

Conditions

Hot Flashes

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Peter F. Schnatz, D.O.

    Hartford Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Lynne Hosig, RN

CONTACT

860-545-1005LHOSIG@harthosp.org

Peter F. Schnatz, D.O.

CONTACT

860-545-4054pschnat@harthosp.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 17, 2007

First Posted

October 19, 2007

Study Start

August 1, 2007

Study Completion

November 1, 2009

Last Updated

July 18, 2008

Record last verified: 2008-07

Locations

US(1)