The study investigates effects of local estrogen therapy on serum estradiol levels in postmenopausal breast cancer patients taking an aromatase inhibitor therapy.

Effects of Vaginal Estrogens on Serum Estradiol Levels in Postmenopausal Women with Breast Cancer Taking an Aromatase Inhibitor.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001234-34-FI

Enrollment

Registered

2019-11-28

Start date

2020-04-08

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer, postmenopausal atrophic vaginitis MedDRA version: 21.1 Level: LLT Classification code 10036398 Term: Postmenopausal atrophic vaginitis System Organ Class: 100000004872 MedDRA version: 21.1 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Letrozol ratiopharm Product Name: Letrozol ratiopharm Product Code: L02BG04 Pharmaceutical Form: Tablet INN or Proposed INN: LETROZOLE CAS Number: 112809-51-5 Trade Name: Vagifem 10mcg Pr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Postmenopausal breast cancer patients on adjuvant treatment with Letrozole with athropical vaginitis. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: Premenopausal patients, patients with irregular use of Letrozole

Design outcomes

Primary

Measure	Time frame
Main Objective: Measurement of serum estradiol levels using sensitive methods during treatment with vaginal estrogen tablets and aromatase inhibitors in breast cancer patients.;Secondary Objective: Not applicable;Primary end point(s): The changes in serum estradiol levels during treatment with aromatase inhibitors and vaginal estrogen therapy.;Timepoint(s) of evaluation of this end point: Baseline levels, levels two weeks, one and three months after treatment initiation	—

Measure

Time frame

Main Objective: Measurement of serum estradiol levels using sensitive methods during treatment with vaginal estrogen tablets and aromatase inhibitors in breast cancer patients.;Secondary Objective: Not applicable;Primary end point(s): The changes in serum estradiol levels during treatment with aromatase inhibitors and vaginal estrogen therapy.;Timepoint(s) of evaluation of this end point: Baseline levels, levels two weeks, one and three months after treatment initiation

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Finland

Contacts

Public ContactSyöpäkeskus

HUS

johanna.mattson@hus.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026