Comparison of Hormonal Therapy: Mediating Hot Flashes Tapering Regimens for Mediating Hot Flashes

  • STATUS
    Recruiting
  • participants needed
    235
  • sponsor
    Hartford Hospital
Updated on 7 November 2020
endocrine therapy
hormone therapy
estradiol
pelvic examination
mammogram
flashes

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.

Description

A Comparison of Hormonal Therapy: Tapering Regimens for Mediating Hot Flashes Clinicians have been asking for years whether a tapering dose of HT would make a difference in the frequency and severity of vasomotor symptoms after menopausal women stop HT therapy. This planned randomized, placebo-controlled trial (RCT) seeks 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. 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. All participants will be randomized to one of the three arms (taper arm, placebo arm, and "cold turkey" arm). Each patient's gynecologist will be aware of the patient's involvement in the study and will assist by providing baseline safety information. All patients will be taken off their current HT/ET regimen and will be placed on study medication (1 mg of Estradiol PO every day for 8 weeks, "stabilization" phase). After the 8-week stabilization period, all participants will begin the therapy corresponding to the arm to which they were randomized. Each patient in the taper or placebo arm will take one capsule per day. The patients in the "cold turkey" arm will discontinued acutely after the stabilization. The patients will keep a diary of the number and frequency of symptoms during the study. Patients will be contacted by phone to confirm that they are completing their diaries and that they have not developed side effects or complications that could force their discontinuation from the study. Patients will be followed for several additional weeks, after discontinuation from treatment or placebo, to monitor for symptoms. At the end of the study, our coordinator will contact the patient to assure that Medroxyprogesterone acetate, MPA, was taken properly by those women who have a uterus. They will also confirm that no other symptoms, complications, or questions have arisen. At that time, they will be able to return to their prior therapy as deemed appropriate by them and their physician. Patients will be recruited by invitation upon presenting for care to their physician. With invitations at recruitment, all patients will be given a study form. Reasons for ineligibility or refusal will be noted. After expressing interest, the physician or practice of record will sign a form acknowledging that their patient has had an annual physical exam (including pelvic exam) within the last 12 months and that a mammogram has been reported as negative (BIRADS I or II) within the last 24 months. An appointment will be made with one of our study personnel or coordinators. The patient will bring the signed form to this visit. At this enrollment / consent visit, their eligibility criteria will be reviewed. All patients will sign the informed consent, and be randomized to a group.

Details
Condition Hot flushes
Treatment Estradiol
Clinical Study IdentifierNCT00547001
SponsorHartford Hospital
Last Modified on7 November 2020

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