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Breast Cancer and Intrauterine Contraception

NCT05148910 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2021-12-08

No results posted yet for this study

Summary

The present work seeks an alternative to the copper IUD for contraception in breast cancer patients, evaluating the satisfaction and continuity of the copper and silver IUD, as well as the quality of life, compared to the copper IUD, especially in the regarding the menstrual bleeding pattern of these patients and possible mechanisms that justify such differences. A randomized (1:1) controlled clinical trial is proposed. Women between 18 and 45 years of age, diagnosed with breast carcinoma through histopathological study, who have had at least one vaginal sexual intercourse in life and wish to use intrauterine contraception will be included.

Conditions

Interventions

DEVICE

Silver and copper IUD (TCu380Ag)

An intrauterine device containing 380mm² of copper with a silver core.

DEVICE

Copper IUD (TCu380A)

An intrauterine device containing 380mm² of copper.

Sponsors & Collaborators

  • Edson Santos Ferreira-Filho

    collaborator UNKNOWN

  • Nilson Roberto de Melo

    collaborator UNKNOWN

  • Isabel Cristina Esposito Sorpreso

    collaborator UNKNOWN

  • José Maria Soares Júnior

    collaborator UNKNOWN

  • José Roberto Filassi

    collaborator UNKNOWN

  • Kátia Cândido Carvalho

    collaborator UNKNOWN

  • Walter da Silva Pinheiro

    collaborator UNKNOWN

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Edmund C Baracat, PhD · Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-06
Primary Completion
2022-09-10
Completion
2022-12-31

Countries

  • Brazil

Study Locations

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Entities

Diseases

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 NCT05148910 on ClinicalTrials.gov