Clinical trial · Observational
Menstrual Cycle Maintenance and Quality of Life: A Prospective Study
NCT00589654CI-TRIAL-00116032active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
Very little is known about the incidence, onset, time course, and symptomatology of premature menopause induced by breast cancer therapy. No prospective study exists. The purpose of the present study is to identify determinants of treatment-related amenorrhea nad its effect on quality of life in a cohort of youg breast cancer patients.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Amenorrhea | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Menstrual Cycle | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 1
- interventionNames
- Other: Questionnaire
Primary outcomes (1)
- measure
- The overall goal of the proposed research is to recruit and follow young breast cancer patients aged 45 and younger, in order to examine menstrual cycle maintenance.
- timeFrame
- Conclusion of the study
Secondary outcomes (1)
- measure
- Examine possible predictors of treatment-related amenorrhea including age, smoking history, race, and treatment variables
- timeFrame
- Conclusion of study
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Non-institutional (community dwelling) woman of any race * Between 18-45 years at the first screening visit * Have regular menstrual cycles * Diagnosed with invasive breast cancer stage I, II, III within the previous eight months * Have physician agreement for patient participation Exclusion Criteria: * No menstrual bleeding cycles * Psychiatric or psychologic abnormality precluding the informed consent process or which would decrease compliance * Previous malignancy (excepting basal and squamous skin cancer and stage 0 cervical cancer) * Stage IV breast malignancy * Residency outside United States * No telephone
References
Publications (0)
Data not yet available
No reference posted for this study.