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NCT06654570
Effects of Vaginal Estrogen on Serum Estradiol During Aromatase Inhibitor Therapy in Breast Cancer Patients with Vulvovaginal Atrophy: a Prospective Trial
Phase 2 trial testing Intravaginal estrogen during adjuvant letrozole in Breast Cancer in 20 participants. Completed in 10 October 2024.
10 October 2024
Quick facts
| Lead sponsor | Helsinki University Central Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 8 April 2020 |
| Primary completion | 10 October 2024 |
| Estimated completion | 10 October 2024 |
| Sites | 1 location across Finland |
Drugs / interventions tested
- Intravaginal estrogen during adjuvant letrozole — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Helsinki University Central Hospital
Who can join
51 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Effects of vaginal estrogen on serum estradiol during aromatase inhibitor therapy in breast cancer patients with vulvovaginal atrophy: a prospective trial.
Faltinová M, Vehmanen L, Lyytinen H, Savolainen-Peltonen H, et al · · 2025 · cited 1× · PMID 39729211 · DOI 10.1007/s10549-024-07564-8
Verify or expand the search:
- PubMed search for NCT06654570
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06654570 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Helsinki University Central Hospital
- Last refreshed: 23 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06654570.
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