This is a pilot study to test whether PYC can improve climacteric symptoms for women who have experienced either surgically or medically induced menopause as part of their treatment for breast or gynecologic cancers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
4 weeks on PYC, then 4 weeks on placebo
4 weeks on PYC, then 4 weeks on placebo
4 weeks on placebo, then 4 weeks on PYC
Legacy Mt. Hood Medical Center
Gresham, Oregon, United States
RECRUITINGLegacy Good Samaritan Medical Center
Portland, Oregon, United States
RECRUITINGLegacy Meridian Park Medical Center
Tualatin, Oregon, United States
RECRUITINGMenopause Rating Scale (MRS)
The MRS will be used to evaluate the efficacy of PYC in decreasing menopausal symptoms as compared to placebo. The difference-from-baseline (DFB) score will be calculated by taking the composite MRS score at 10 weeks and 12 weeks compared to the MRS score at baseline to determine whether or not PYC reduces symptoms, if the effects last beyond actively taking PYC, and if so, how long. The purpose of multiple time point assessments is two-fold: first, some patients will be taking placebo and some will be taking active drug in the first month, and vice versa during the second month. Therefore, an assessment needs to be done at each timepoint, weeks 4 and 8. Second, we are interested in understanding how long the symptoms management may last without actively taking drug, which accounts for the 10 week and 12 week timepoints.
Time frame: The MRS will be administered at baseline, after 4 weeks, after 8 weeks, 2 week follow-up (10 weeks), and 1 month follow up (12 weeks) with the intention of calculating DFB score at each time point.
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4 weeks on placebo, then 4 weeks of PYC