NCT04379024

Brief Summary

Pilot study to test feasibility of 6 months of Duavee® vs wait-list control in post-menopausal women symptomatic for hot flashes.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
25 days until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

October 29, 2021

Status Verified

March 1, 2021

Enrollment Period

1.2 years

First QC Date

May 3, 2020

Last Update Submit

October 22, 2021

Conditions

Focus of Study is Healthy Women at Risk for Breast Cancer

Keywords

ImagingBiomarkers

Outcome Measures

Primary Outcomes (1)

  • Number of potential participants who consent to enrollment

    Trial design is acceptable to potential subjects, as evidenced by participation

    Enrollment

Secondary Outcomes (2)

  • Change in breast background parenchymal enhancement (BPE)

    6 months

  • Change in fibroglandular volume (FGV)

    6 months

Study Arms (2)

Immediate active agent

EXPERIMENTAL

Duavee. One capsule daily for 6 months (+/- 1 month) of Duavee (Bazedoxifene 20 mg plus conjugated estrogens 0.45 mg)

Drug: DUAVEE 0.45Mg-20Mg Tablet

Delayed active agent

OTHER

No intervention for first 6 months. Then option to receive daily Duavee for 6 months.

Drug: DUAVEE 0.45Mg-20Mg Tablet

Interventions

DUAVEE 0.45Mg-20Mg TabletDRUG

One capsule daily for 6 months (+/- 1 month)

Also known as: Bazedoxifene 20 mg plus conjugated estrogens 0.45 mg
Delayed active agentImmediate active agent

Eligibility Criteria

Age45 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160-7820, United States

Location

Related Publications (1)

  • Fabian CJ, Nye L, Powers KR, Nydegger JL, Kreutzjans AL, Phillips TA, Metheny T, Winblad O, Zalles CM, Hagan CR, Goodman ML, Gajewski BJ, Koestler DC, Chalise P, Kimler BF. Effect of Bazedoxifene and Conjugated Estrogen (Duavee) on Breast Cancer Risk Biomarkers in High-Risk Women: A Pilot Study. Cancer Prev Res (Phila). 2019 Oct;12(10):711-720. doi: 10.1158/1940-6207.CAPR-19-0315. Epub 2019 Aug 16.

    PMID: 31420361BACKGROUND

MeSH Terms

Interventions

bazedoxifeneEstrogens, Conjugated (USP)

Intervention Hierarchy (Ancestors)

Estradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Carol J Fabian, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Randomization assignment is masked to all roles prior to randomization. Subsequent to randomization, agent is dispensed open-label.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized to active agent or wait-list control.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 3, 2020

First Posted

May 7, 2020

Study Start

June 1, 2020

Primary Completion

July 30, 2021

Study Completion

July 31, 2021

Last Updated

October 29, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)