Recruiting

Hormonal Therapy

Sponsor:

Hartford Hospital

Code:

NCT00547001

Conditions

Hot Flashes

Night Sweats

Eligibility Criteria

Sex: Female

Age: 35 - 70

Healthy Volunteers: Accepted

Interventions

Estradiol

Study Details

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.

Conditions

Hot Flashes

Night Sweats

Study ID

NCT00547001

Start date

Aug, 2007

Status verified date

Jul, 2008

Completion date

Nov, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 35 - 70

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

235 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 1

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.

placebo comparator: 2

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.

no intervention: 3

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.

Interventions

Estradiol

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

Primary outcome measure

  • 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. [ Time Frame: During the tapering and post taper time period. ]

Central Contacts and Locations

Central contacts

Anna Lynne Hosig, RN

860-545-1005LHOSIG@harthosp.org

Peter F. Schnatz, D.O.

860-545-4054pschnat@harthosp.org

Locations

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06102

Contacts

Margarita Garcia

860-545-2196

More Information

Sponsor

Hartford Hospital

Last update posted

Jul 18, 2008

Last verified

Jul, 2008

Keywords

  • Menopause
  • Hot flashes
  • vasomotor symptoms
  • tapering regimen
  • hormonal therapy
  • Other menopausal symptoms including mood changes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hartford Hospital on 2008-07-18.