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Hormone Therapy

1 for Hot Flashes

N/A
Waitlist Available
Led By Peter F. Schnatz, D.O.
Research Sponsored by Hartford Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the tapering and post taper time period.
Awards & highlights

Study 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.

Eligible Conditions
  • Hot Flashes
  • Night Sweats

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the tapering and post taper time period.
This trial's timeline: 3 weeks for screening, Varies for treatment, and during the tapering and post taper time period. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
Secondary outcome measures
frequency, severity, and "Severity Index" of hot flashes.

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: 3Active Control1 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.
Group II: 1Active Control1 Intervention
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.
Group III: 2Placebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Hartford HospitalLead Sponsor
133 Previous Clinical Trials
18,697 Total Patients Enrolled
Peter F. Schnatz, D.O.Principal InvestigatorHartford Hospital
1 Previous Clinical Trials
120 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Comparison of Hormonal Therapy: Mediating Hot Flashes Tapering Regimens for Mediating Hot Flashes
2007. "Comparison of Hormonal Therapy: Mediating Hot Flashes Tapering Regimens for Mediating Hot Flashes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00547001.
All > Hot Flashes
~13 spots leftby May 2025
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