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REVIVE: Replens vs Vaginal Estrogen for Vaginal Dryness in Breast Cancer Patients on AI Therapy
NCT01984138Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Sep 2013
- Primary completion
- Jun 2025
- Countries
- 1
- Modality
- Hormone, Biologic
- Drugs
- estradiol
- Conditions
- atrophic vaginitis
01
Overview
Phase 2, randomised, open-label trial of estradiol in atrophic vaginitis (2 arms). Primary endpoint: Number of participants that show improvement of symptoms at 4.5 years. Started Sep 2013; status: active, not recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Vaginal Estrogen
Estring (estradiol vaginal ring) or Vagifem (estradiol vaginal tablet) per patient preference.
REPLENS
Replens vaginal moisturizer applied three times each week.
03
Who it enrols
Post-menopausal women >=18 years with stage I-III ER+ breast cancer currently on adjuvant AI therapy, experiencing atrophic vaginitis symptoms, with no recent exogenous estrogen use or current vaginal infection.
04
Endpoints
Primary
Number of participants that show improvement of symptoms
Secondary
Compliance of use of Aromatase Inhibitor
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