Vaginal Prasterone In Vaginal Atrophy In Breast Cancer Survivors

NCT04705883 | Completed Phase 4

• 1 other identifier: Versión 4- 20/09/2020
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

VAGINAL PRASTERONE in the treatment of VAGINAL ATROPHY IN PATIENTS WITH BREAST CANCER TREATMENT WITH AROMATASE INHIBITORS (VIBRA STUDY)

Conditions

Vulvar Atrophy; Breast Cancer; Genitourinary Syndrome of Menopause

Keywords

Breast Cancer; Genitourinary Syndrome of Menopause

Outcome Measures

Primary Outcomes (1)

• Estradiol

  Ultrasensitive blood estradiol, serum levels measured in pg/ml

  12 months

Secondary Outcomes (5)

• Vaginal pH

  12 months

• Vaginal maturation index

  12 months

• Vaginal health index

  12 months

• Female Sexual Function Index

  12 months

• Social Functioning Questionnaire

  12 months

Study Arms (1)

Prasterone

OTHER

10 patients will be treated using prasterone during 6 months.

Drug: Prasterone (DHEA), Micronized

Interventions

Prasterone (DHEA), Micronized DRUG

Vaginal prasterone 6,5mg/24h first month, next 5 months 6,5mg/48h, vaginal administration.

Also known as: Intrarosa

Prasterone

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast cancer treated with anti-hormonal therapy based on inhibitors of aromatase (IA) (letrozole, anastrozole or exemestane) ± analogues of the GnRH (aGnRH)
• Menopause (natural or induced) and signs / symptoms of vulvovaginal atrophy
• Cytology and / or determination of Human Papillomavirus (HPV) negative
• Intention or willingness to have sex

You may not qualify if:

• To have received topical hormonal treatment in the last 6 months or Have used vaginal moisturizers and / or lubricants during the 30 days prior to the study treatment
• To have received treatment with laser, radiofrequency, hyaluronic acid, etc. in the vagina during the last two years at the beginning of the study
• To Have: an active infection of the genital tract; an intraepithelial neoplasm of the cervix, vagina or vulva; suspected of suffering or having been treated for cancer of the genital tract; suffer a genital prolapse of II degree or greater

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Camil Castelo-Branco

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 12, 2021
• Study Start: September 1, 2020
• Primary Completion: November 8, 2021
• Study Completion: December 1, 2021
• Last Updated: February 22, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)