Clinical trial · Interventional
Effects of Vaginal Estrogen on Serum Estradiol During Aromatase Inhibitor Therapy in Breast Cancer Patients with Vulvovaginal Atrophy: a Prospective 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)
Purpose: This study aimed to analyze changes in serum estradiol (E2) levels during concurrent vaginal estradiol therapy and adjuvant letrozole in postmenopausal breast cancer (BC) patients with vulvovaginal atrophy (VVA). Secondary objectives included assessing the effects of therapy on vaginal atrophy, quality of life (QoL) and menopause-related symptoms. Methods: Postmenopausal patients undergoing adjuvant letrozole therapy and experiencing VVA symptoms were treated with vaginal estradiol for 12 weeks. Gynecologic examination and symptom screening were conducted at baseline and after 12 weeks. Serum E2 levels were analyzed at baseline, and at two, four, eight, and 12 weeks. E2 levels were measured using both a routine liquid chromatography-tandem mass spectrometry (LC-MS/MS) method and a highly sensitive (hsE2-MS) LC-MS/MS method.
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 |
|---|---|---|---|
| Intravaginal estrogen during adjuvant letrozole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intravaginal estradiol during adjuvant letrozole
- description
- Eligible patients were treated with Vagifem® (17β-estradiol hemihydrate) 10 μg vaginal tablets for 12 weeks. Patients were instructed to insert one vaginal tablet daily using the provided applicator for 14 consecutive days, followed by one tablet twice weekly (Monday and Thursday evenings).
- interventionNames
- Drug: Intravaginal estrogen during adjuvant letrozole
Primary outcomes (1)
- measure
- Serum estradiol level
- timeFrame
- 12 weeks
- description
- The primary objective was to analyze changes in serum E2 levels using two LC-MS/MS methods during concurrent adjuvant AI therapy and intravaginal estradiol treatment. ). Blood samples were collected at baseline, prior to the initiation of study treatment, and at two, four, eight, and 12 weeks thereafter, within 24 to 60 hours of vaginal tablet administration. Serum E2 levels were measured using both a routine LC-MS/MS method (Sciex Citrine™ Triple Quad™ LC-MS/MS system, E2-MS, HUSLAB, LLOQ 10 pmol/L) and a highly sensitive LC-MS/MS method (hsE2-MS, LLOQ 5 pmol/L, CV \< 20%, LOD 1 pmol/L). The hsE2-MS method allowed for the detection of very low serum E2 concentrations, even below the LLOQ, within the range of 1-5 pmol/L, providing a precise assessment of the effect of letrozole and vaginal estrogen on E2 levels.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 51 Years
Show eligibility criteria text
Inclusion Criteria: * Eligible patients were postmenopausal women (\> 50 years old) with early-stage hormone receptor-positive BC treated with adjuvant letrozole for at least six months and developed symptoms of AV during this period. Exclusion Criteria: * Exclusion criteria included premenopausal status, recent use of local estrogen therapy within the previous three months, irregular use of letrozole, and metastatic disease.
References
Publications (0)
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