Breast Cancer and Intrauterine Contraception

NCT05148910 | Unknown

• 1 other identifier: 26272819.3.0000.0068
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer; Contraception

Keywords

breast cancer; contraception; intrauterine device

Outcome Measures

Primary Outcomes (9)

• Continuity

  Number of women that decide to continue using the method assigned

  3 months

• Continuity

  Number of women that decide to continue using the method assigned

  6 months

• Continuity

  Number of women that decide to continue using the method assigned

  12 months

• Subjects' Satisfaction

  Number of women who are satisfied with the method assigned

  3 months

• Subjects' Satisfaction

  Number of women who are satisfied with the method assigned

  6 months

• Subjects' Satisfaction

  A likert Scale including the question "Are you satisfied with the IUD?" and the answers: extremely satisfied; very satisfied; a little satisfied; neither satisfied nor dissatisfied; a little dissatisfied; very dissatisfied; extremely dissatisfied

  12 months

• Bleeding pattern

  Number of days of bleeding, punctuation through pictorial assessment blood chart

  3 months

• Bleeding pattern

  Number of days of bleeding, punctuation through pictorial assessment blood chart

  6 months

• Bleeding pattern

  Number of days of bleeding, punctuation through pictorial assessment blood chart

  12 months

Secondary Outcomes (17)

• Quality of life (SF-36)

  12 months

• Quality of life (EORTC QLQ-C30)

  12 months

• Complete blood count

  Baseline

• Complete blood count

  6 months

• Complete blood count

  12 months

Study Arms (2)

Copper IUD (TCu380A)

ACTIVE COMPARATOR

Women receiving an intrauterine device (IUD) containing 380mm² of copper.

Device: Copper IUD (TCu380A)

Silver and copper IUD (TCu380Ag)

EXPERIMENTAL

Women receiving an intrauterine device (IUD) containing 380mm² of copper with a silver core.

Device: Silver and copper IUD (TCu380Ag)

Interventions

Silver and copper IUD (TCu380Ag) DEVICE

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

Silver and copper IUD (TCu380Ag)

Copper IUD (TCu380A) DEVICE

An intrauterine device containing 380mm² of copper.

Copper IUD (TCu380A)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women diagnosed with breast carcinoma through histopathological study
• At least one vaginal sexual intercourse in life
• Wish to use intrauterine contraception

You may not qualify if:

• Currently pregnant women
• Postmenopausal women
• Hysterectomized and/or bilaterally ovariectomized women
• Abortion less than four weeks
• Childbirth less than six weeks
• Known endometrial cavity changes
• Severe anemia (hemoglobin \< 8 g/dL)
• Severe thrombocytopenia
• Acute purulent cervicitis
• Current endometritis
• Acute pelvic inflammatory disease
• Genital tuberculosis
• Genital bleeding of unknown cause
• Cervical or endometrial cancer
• Wilson's disease

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Edson Santos Ferreira-Filho: collaborator
• Nilson Roberto de Melo: collaborator
• Isabel Cristina Esposito Sorpreso: collaborator
• José Maria Soares Júnior: collaborator
• José Roberto Filassi: collaborator
• Kátia Cândido Carvalho: collaborator
• Walter da Silva Pinheiro: collaborator

Study Sites (1)

Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo

São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Edmund C Baracat, PhD

  Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose M Soares Junior, PhD

CONTACT

551126617621; jsoares415@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: December 8, 2021
• Study Start: August 6, 2020
• Primary Completion: September 10, 2022
• Study Completion: December 31, 2022
• Last Updated: December 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)