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

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Cancer [C04]; Breast cancer, postmenopausal atrophic vaginitis; MedDRA version: 21.1Level: LLTClassification code 10036398Term: Postmenopausal atrophic vaginitisSystem Organ Class: 100000004872; MedDRA version: 21.1Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2019-001234-34-FI
• Lead Sponsor: HUS Syöpäkeskus

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-28
• Last Update Posted: 29 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 30

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

Premenopausal patients, patients with irregular use of Letrozole

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified