GRACE-trial: A randomized active-controlled trial for vulvovaginal atrophy in breast cancer patients on endocrine therapy

Phase 1

• Conditions: Breast cancer patients on endocrine therapy (AI or SERM) with symptoms of vulvovaginal atrophy; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-001921-31-BE
• Lead Sponsor: niversity Hospital Ghent

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-27
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 190

Inclusion Criteria

• Breast cancer patient
• Current endocrine therapy (AI or SERM)
• Postmenopausal status, defined by:
o 12 months amenorrhoe or
o 6 months amenorrhoe and FSH level of >40 mIU/mL or
o >6 weeks after bilateral oophorectomy or
o Induced postmenopause (ovarian function suppression using GnRH-analogue)
• Presence of one or more symptoms of vulvovaginal atrophy (dyspareunia, dryness, irritation)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 63
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 127

Exclusion Criteria

• A history of vulvar or vaginal surgery
• Current other vulvar or vaginal disease
• Recent use of antibiotics/antifungals/corticosteroids (less than 1 month)
• Current use of vaginal hormonal treatment or vaginal moisturizer
o Inclusion is possible after a washout period of 4 weeks

Study & Design

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