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Intrarosa 6.5 mg pessary

DRUG2 trials

Sponsors

Istituto Europeo Di Oncologia S.r.l., Universitair Ziekenhuis Gent

Conditions

Breast cancer patients on endocrine therapy (AI or SERM) with symptoms of vulvovaginal atrophyPostmenopausal women with previous breast cancer or currently under anti-oesterogenic therapy (aromatase inhibitor +/- LHRH analogue) presenting vulvarvaginal or urinary bothersome symptoms (genitourinary syndrome).

Phase 3

PROPOSE: Effect of Intravaginal Prasterone on Genitourinary Syndrome in Women in Menopause with previous Breast Cancer or currently under treatment with endocrine therapy for Breast Cancer with aromatase inhibitor +/- LHRHa
RecruitingCTIS2023-506211-18-00
Istituto Europeo Di Oncologia S.r.l.Postmenopausal women with previous breast cancer or currently under anti-oesterogenic therapy (aromatase inhibitor +/- LHRH analogue) presenting vulvar, vaginal or urinary bothersome symptoms (genitourinary syndrome).
Start: 2025-01-09Target: 95Updated: 2025-11-25

Phase 4

A randomized active-controlled trial for vulvovaGinal atRophy in breAst Cancer patients on Endocrine therapy (GRACE-trial)
RecruitingCTIS2024-510845-33-00
Universitair Ziekenhuis GentBreast cancer patients on endocrine therapy (AI or SERM) with symptoms of vulvovaginal atrophy
Start: 2025-06-23Target: 190Updated: 2025-06-20