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

• Status: Unknown status
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hartford Hospital
• Treatments: Estradiol

Criteria

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