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Prospective Research of Outcomes After Salpingo-oophorectomy

NCT01948609 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2022-09-07

No results posted yet for this study

Summary

PROSper is a prospective cohort study of 100 women 35-50 years of age with BRCA 1/2 mutations who have elected to either undergo risk reducing salpingo-oophorectomy (RRSO) or nonsurgical management. The investigators will compare the change in cardiovascular health, bone health, sexual function, quality of life, and menopausal symptoms over 3 years of follow-up between women who undergo RRSO (baseline just prior to surgery) and age-matched controls that do not undergo RRSO.

The investigators hypothesis is that women who undergo a premature surgical menopause induced by RRSO have worse cardiovascular health and bone health compared with women who do not undergo RRSO.

Conditions

  • BRCA1 Gene Mutation
  • BRCA2 Gene Mutation

Sponsors & Collaborators

Principal Investigators

  • Vanessa Jacoby, MD, MAS · University of California, San Francisco

Eligibility

Min Age
35 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01948609 on ClinicalTrials.gov