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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001921-31-BE

Enrollment

190

Registered

2021-09-27

Start date

2021-10-25

Completion date

Unknown

Last updated

2024-07-08

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

Conditions

Breast cancer patients on endocrine therapy (AI or SERM) with symptoms of vulvovaginal atrophy

Interventions

Trade Name: Oekolp Product Name: Oekolp Pharmaceutical Form: Vaginal capsule INN or Proposed INN: ESTRIOL CAS Number: 50-27-1 Concentration unit: mg milligram(s) Concentration type: equal Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Firstly, the efficacy of the different treatment regimes will be assessed. The assessment will be based on PROMs and clinical evaluations such as vaginal pH and the vaginal maturation index, the latter a direct microscopic evaluation of the vaginal epithelium. Secondly, safety of the different groups will be assessed. Although previous research already indicated no increased breast cancer recurrence, there is no direct comparative data available towards the different available treatment regimes. This will be tackled in this study. Evaluation will be done be measuring sex hormone concentrations systemically, which will be a surrogate for safety evaluation. ;Secondary Objective: The secondary objective in this study is the identification of microbial alterations after treatment initiation. Identification of these alterations can help in further understanding of the pathophysiology of vulvovaginal atrophy and potentially create opportunities for new treatment strategies towards vulvovaginal atrophy in breast cancer patients on endocrine therapy.;Primary end point(s): The primary endpoint of this study is the efficacy of the implemented treatment regimes. Efficacy will be assessed based on patient-reported outcome measurements, being two validated questionnaires: EQ5D-questionnaire (Appendix 1) and the FACT-ES questionnaire (Appendix 2). This endpoint will be assessed at three time points: at start, after 6 weeks, and at the end (after 12 weeks). ;Timepoint(s) of evaluation of this end point: at start, after 6 weeks, and at the end (after 12 weeks)	—

Measure

Time frame

Main Objective: Firstly, the efficacy of the different treatment regimes will be assessed. The assessment will be based on PROMs and clinical evaluations such as vaginal pH and the vaginal maturation index, the latter a direct microscopic evaluation of the vaginal epithelium. Secondly, safety of the different groups will be assessed. Although previous research already indicated no increased breast cancer recurrence, there is no direct comparative data available towards the different available treatment regimes. This will be tackled in this study. Evaluation will be done be measuring sex hormone concentrations systemically, which will be a surrogate for safety evaluation. ;Secondary Objective: The secondary objective in this study is the identification of microbial alterations after treatment initiation. Identification of these alterations can help in further understanding of the pathophysiology of vulvovaginal atrophy and potentially create opportunities for new treatment strategies towards vulvovaginal atrophy in breast cancer patients on endocrine therapy.;Primary end point(s): The primary endpoint of this study is the efficacy of the implemented treatment regimes. Efficacy will be assessed based on patient-reported outcome measurements, being two validated questionnaires: EQ5D-questionnaire (Appendix 1) and the FACT-ES questionnaire (Appendix 2). This endpoint will be assessed at three time points: at start, after 6 weeks, and at the end (after 12 weeks). ;Timepoint(s) of evaluation of this end point: at start, after 6 weeks, and at the end (after 12 weeks)

—

Secondary

Measure	Time frame
Secondary end point(s): The secondary endpoint is the safety of the implemented treatments. As a surrogate for safety, blood serum concentration of sex steroid hormones will be determined. This endpoint will be assessed at three time points: at start, after 6 weeks, and at the end (after 12 weeks).;Timepoint(s) of evaluation of this end point: at start, after 6 weeks, and at the end (after 12 weeks)	—

Measure

Time frame

Secondary end point(s): The secondary endpoint is the safety of the implemented treatments. As a surrogate for safety, blood serum concentration of sex steroid hormones will be determined. This endpoint will be assessed at three time points: at start, after 6 weeks, and at the end (after 12 weeks).;Timepoint(s) of evaluation of this end point: at start, after 6 weeks, and at the end (after 12 weeks)

—

Countries

Belgium

Contacts

Public ContactHIRUZ CTU

University Hospital Ghent

hiruz.ctu@uzgent.be+3293320500

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026