Clinical trial · Interventional
Breast Cancer and Intrauterine Contraception
Satisfaction, Continuity, and Bleeding Patterns in Patients With Breast Cancer Using Copper and Silver Intrauterine Device (IUD) Compared to Copper IUD: a Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Contraception | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Copper IUD (TCu380A) | Device | — | UNRESOLVED |
| Silver and copper IUD (TCu380Ag) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Copper IUD (TCu380A)
- description
- Women receiving an intrauterine device (IUD) containing 380mm² of copper.
- interventionNames
- Device: Copper IUD (TCu380A)
- type
- EXPERIMENTAL
- label
- Silver and copper IUD (TCu380Ag)
- description
- Women receiving an intrauterine device (IUD) containing 380mm² of copper with a silver core.
- interventionNames
- Device: Silver and copper IUD (TCu380Ag)
Primary outcomes (9)
- measure
- Continuity
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Women diagnosed with breast carcinoma through histopathological study * At least one vaginal sexual intercourse in life * Wish to use intrauterine contraception Exclusion Criteria: * 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 * Cognitive or psychiatric disorder that makes adherence to the study protocol unfeasible * Tubal ligation * Women who do not agree to participate in the study
References
Publications (0)
Data not yet available