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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506211-18-00
Enrollment
95
Registered
2024-07-26
Start date
2025-01-09
Completion date
Unknown
Last updated
2025-11-25

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

Conditions

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).

Brief summary

Establish the subjective improvement of genitourinary symptoms in breast cancer women at intervals defined by the study

Detailed description

To define the role of genito-urinary syndrome on quality of life, in particular on sexual function and mood wellbeing, in women with breast cancer before, during and after the treatment, Establish an improvement in tissue trophism throught gynecological evaluation, use of validated scales (Vaginal Health Index) and determination of the maturation index on vaginal cytology, Measurement of serum estradiol at set intervals before, during and after treatment

Interventions

Sponsors

Istituto Europeo Di Oncologia S.r.l.
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Establish the subjective improvement of genitourinary symptoms in breast cancer women at intervals defined by the study

Secondary

MeasureTime frame
To define the role of genito-urinary syndrome on quality of life, in particular on sexual function and mood wellbeing, in women with breast cancer before, during and after the treatment, Establish an improvement in tissue trophism throught gynecological evaluation, use of validated scales (Vaginal Health Index) and determination of the maturation index on vaginal cytology, Measurement of serum estradiol at set intervals before, during and after treatment

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026