Overview
Pilot Study of Effects of Duavee® on Imaging and Blood Biomarkers In Women With Menopausal Symptoms
Status:
Terminated
Terminated
Trial end date:
2021-07-31
2021-07-31
Target enrollment:
0
0
Participant gender:
Female
Female
Summary
Pilot study to test feasibility of 6 months of Duavee® vs wait-list control in post-menopausal women symptomatic for hot flashes.Phase:
Early Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Carol Fabian, MDCollaborator:
Breast Cancer Research FoundationTreatments:
Bazedoxifene
Estrogens
Estrogens, Conjugated (USP)
Criteria
Inclusion Criteria:- Women who report vasomotor symptoms (hot flashes or night sweats)
- No menstrual periods for at least 3 months
- Must have at least one ovary (hysterectomy is permitted; bilateral salpingo-
oophorectomy is excluded).
- BMI <36 kg/m2
- Moderate risk of developing breast cancer based on having any one or more of the
following:
- First or 2nd degree relative with breast cancer
- Known carrier of moderate to high penetrance germline mutation
- Prior breast biopsy showing proliferative breast disease or multiple biopsies
- High mammographic density (Volpara® categories c or d or BIRADs density
assessment as heterogeneously or extremely dense (c or d).
- IBIS Breast Cancer Risk Evaluation Version 8 10-year relative risk of >2X that
for the population for age group.
Exclusion Criteria:
- Risk: A prior biopsy showing LCIS, DCIS, or invasive breast cancer.
- Medical Conditions:
- Have a predisposition to or prior history of thromboembolism, deep venous
thrombosis, pulmonary embolism, or stroke
- History of renal or liver disease
- Prior invasive ovarian or endometrial cancer
- Medications
- Current anticoagulant use other than low dose aspirin
- Taking systemic hormones within two months (eight weeks) prior to baseline MRI
and mammogram.
- Taking tamoxifen, raloxifene, Duavee, or any selective estrogen receptor
modulator, or an aromatase inhibitor within 12 months prior to baseline MRI and
mammogram.