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Trial Title:
Effect of Intravaginal Prasterone on Symptoms of Genitourinary Syndrome of Menopause (GSM) in Women in Menopause with Previous Breast Cancer
NCT ID:
NCT06611514
Condition:
Women with Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Dehydroepiandrosterone
Conditions: Keywords:
genitourinary syndrome
prasterone
breast cancer
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Prasterone (DHEA)
Description:
Prasterone 6.5 mg vaginal tablets
Arm group label:
intravaginal Prasterone
Summary:
The goal of this interventional study is to evaluate the effect of Intravaginal
Prasterone for the treatment of moderate to severe symptoms of genitourinary syndrome
(GSM) due to natural, surgical or treatment-induced menopause and the effect on the
quality of life, including sexual function and mood well-being, in women with Breast
Cancer. A sample size of 95 patients will be needed to show that the proportion of women
showing symptom improvement is greater than 50%. Subjects will be followed up at four
weeks and twelve weeks of treatment. One and three-month outcomes will be provided after
the end of treatment. Comparison between menopausal women with previous breast cancer
that have finished hormonal therapy or with ER negative breast cancer and women currently
under endocrine therapy with AIs will be performed.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically confirmed breast cancer, completely excised
- Natural or iatrogenic menopausal status
- No evidence of distant metastasis
- Self-identified moderate to severe symptoms of genitourinary syndrome
- Normal kidney and liver function
- Written Informed Consent signed and dated by patient
- Negative Papanicolau (Pap) Smear Cytology Test within 1 year prior to enrollment
Exclusion Criteria:
- Vaginal or uterine bleeding of unknown origin
- Current diagnosis of any non-breast malignancy
- Metastatic disease
- Currently on chemiotherapy
- Currently on treatment with tamoxifen
- Mentally incompetent or evidence of active substance or alcohol abuse
- Endometrial hyperplasia
- Pregnancy or lactation
- Currently use of other vaginal therapy for the same purpose (if present, they have
to be stopped 15 days before baseline visit)
- Clinically significant metabolic or endocrine disease not controlled by medication
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
European Institute of Oncology
Address:
City:
Milan
Zip:
20141
Country:
Italy
Contact:
Last name:
SILVIA MARTELLA
Phone:
0039 02 943742104
Email:
silvia.martella@ieo.it
Contact backup:
Last name:
SILVIA MARTELLA
Start date:
October 1, 2024
Completion date:
January 1, 2027
Lead sponsor:
Agency:
European Institute of Oncology
Agency class:
Other
Source:
European Institute of Oncology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06611514
