A randomized active-controlled trial for vulvovaGinal atRophy in breAst Cancer patients on Endocrine therapy (GRACE-trial)
Phase 1
Recruiting
- Conditions
- Breast cancer patients on endocrine therapy (AI or SERM) withsymptoms of vulvovaginal atrophyTherapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2024-510845-33-00
- Lead Sponsor
- niversitair Ziekenhuis Gent
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 190
Inclusion Criteria
Breast cancer patient, Current endocrine therapy (AI or SERM), Postmenopausal status, defined by: 12 months amenorrhoe or 6 months amenorrhoe and FSH level of >40 mIU/mL or Induced postmenopause (ovarian function suppression using GnRH-analogue) >6 weeks after bilateral oophorectomy or, Presence of one or more symptoms of vulvovaginal atrophy (dyspareunia, dryness, irritation)
Exclusion Criteria
A history of vulvar or vaginal surgery, Current other vulvar or vaginal disease (e.g. dysplasia, fungal infection,…), Recent use of antibiotics/antifungals/corticosteroids (less than 1 month), Current use of vaginal hormonal treatment or vaginal moisturizer (inclusion is possible after a washout period of 4 weeks)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method