Comparison of Hormonal Therapy: Mediating Hot Flashes Tapering Regimens for Mediating Hot Flashes
Status unconfirmed · Not applicable
Conditions studied: Hot Flashes, Night Sweats
In brief
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.
Key facts
- Study ID
- NCT00547001
- Run by
- Hartford Hospital
- People needed
- 235
- Starts
- 2007-08-01
- Expected to finish
- 2009-11-01
- Last updated by the study team
- 2008-07-18
Who can join
Age: 35 and older, up to 70. Sex: female. Healthy volunteers: accepted.
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
Where it is running
- Hartford Hospital — Hartford, Connecticut, United States (enrolling)
Full record on ClinicalTrials.gov
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