Clinical trial · Interventional
Trial of Vaginal Estrogen for Urogenital Symptom Relief in Women on Aromatase Inhibitors
Trial of Vaginal Estrogen for Urogenital Symptom Relief in Women on Aromatase Inhibitors: Systemic Impact Versus Local Objective Benefits and Quality of Life
- 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)
Vagifem, is the most appropriate medication to treat bladder and vaginal symptoms such as vaginal dryness and urinary discomfort. The purpose of this research study is to see the benefit this three month vaginal estrogen tablet, Vagifem, has on the bladder, vaginal symptoms and health. The investigators also want to monitor whether the bones might be impacted by estrogen or its absence. If there is an effect on bones, it means that some estrogen may be absorbed from the tablet to affect other places in the body. The investigators are hoping to prove this is not the case. The investigators will also be measuring the quality of life of women participating in the study.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vagifem | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vagifem
- description
- Postmenopausal women diagnosed with breast cancer, are currently on an anti-estrogen called an aromatase inhibitor and you have agreed to undergo treatment with Vagifem based on your physician's recommendation.
- interventionNames
- Behavioral: Vagifem
Primary outcomes (1)
- measure
- Changes in serum estrogen levels
- timeFrame
- 12 Weeks
- description
- Changes in serum estrogen levels will be measured up to 12 weeks in post-menopausal women receiving adjuvant aromatase inhibitors during treatment with low dose vaginal estradiol 10 ug tablet, Vagifem.
Secondary outcomes (1)
- measure
- Quality of Life
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Treatment of Urogenital symptoms with Vagifem, as deemed appropriate by the treating physician 2. History of breast cancer stages 0-III 3. Currently being treated with Aromatase Inhibitors (brand not restrictive) for 3 months or longer 4. Postmenopausal women including those with medically induced menopause 5. Urogenital symptoms consistent with vaginal atrophy. 6. Age 18 years or greater 7. Able to participate in informed consent process 8. Able to read/speak English 9. Able to take daily doses of Vitamin D and Calcium Exclusion Criteria: 1. Abnormal or unexplained uterine bleeding 2. Unable to give informed consent
References
Publications (0)
Data not yet available