Effect of Intravaginal Prasterone on Symptoms of Genitourinary Syndrome of Menopause (GSM) in Women in Menopause With Previous Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2027-01-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Women With Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intravaginal Prasterone

Group Type EXPERIMENTAL

Prasterone (DHEA)

Intervention Type DRUG

Prasterone 6.5 mg vaginal tablets

Interventions

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Prasterone (DHEA)

Prasterone 6.5 mg vaginal tablets

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No