Local prasterone for the treatment of vaginal atrophy

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001077-79-ES

Enrollment

Registered

2020-06-12

Start date

2020-10-16

Completion date

Unknown

Last updated

2026-01-27

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

Conditions

Vaginal atrophy

Interventions

Trade Name: Intrarosa Product Name: intrarosa Product Code: EMEA/H/C/004138 Pharmaceutical Form: Pessary

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1 CM treated with anti-hormonal therapy based on inhibitors of aromatase (IA) (letrozole, anastrozole or exemestane) ± analogues of the GnRH (aGnRH) 2 Menopause (natural or induced) and signs / symptoms of vulvovaginal atrophy 3 Cytology and / or determination of Human Papillomavirus (HPV) negative 4 Intention or willingness to have sex 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 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1 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 2 to have received treatment with laser, radiofrequency, hyaluronic acid, etc. in the vagina during the last two years at the beginning of the study 3 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

Design outcomes

Primary

Measure	Time frame
Main Objective: Verify a clinical improvement of AVV without increasing levels of ultrasensitive blood estradiol in breast cancer survivors treated with aromatase inhibitors by administering vaginal prasterone.;Secondary Objective: a. Report improvement of symptoms, sexual function and quality of life b. Verify a decrease in vaginal pH c. Confirm an improvement in the maturational index of the vaginal epithelium d. Demonstrate the non-modification of serum estrogen levels by determination of ultrasensitive estradiol;Primary end point(s): Ultrasensitive estradiol plasma levels;Timepoint(s) of evaluation of this end point: Basal, 15 days & months 1, 3, 6	—

Measure

Time frame

Main Objective: Verify a clinical improvement of AVV without increasing levels of ultrasensitive blood estradiol in breast cancer survivors treated with aromatase inhibitors by administering vaginal prasterone.;Secondary Objective: a. Report improvement of symptoms, sexual function and quality of life b. Verify a decrease in vaginal pH c. Confirm an improvement in the maturational index of the vaginal epithelium d. Demonstrate the non-modification of serum estrogen levels by determination of ultrasensitive estradiol;Primary end point(s): Ultrasensitive estradiol plasma levels;Timepoint(s) of evaluation of this end point: Basal, 15 days & months 1, 3, 6

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Secondary

Measure	Time frame
Secondary end point(s): vaginal pH vaginal cytological sampling to determine the maturational index. Questionnaires: Visual Analog Scale (VAS) to assess the symptoms of AVV Female Sexual Function Index Quality of life Short Form 12 (SF-12) Likert scale of satisfaction with treatment: from 0 to 5. 0 indicates that the patient is not at all satisfied with the treatment; 5 indicates maximum satisfaction.;Timepoint(s) of evaluation of this end point: Basal, 15 days & months 1, 3, 6	—

Measure

Time frame

Secondary end point(s): vaginal pH vaginal cytological sampling to determine the maturational index. Questionnaires: Visual Analog Scale (VAS) to assess the symptoms of AVV Female Sexual Function Index Quality of life Short Form 12 (SF-12) Likert scale of satisfaction with treatment: from 0 to 5. 0 indicates that the patient is not at all satisfied with the treatment; 5 indicates maximum satisfaction.;Timepoint(s) of evaluation of this end point: Basal, 15 days & months 1, 3, 6

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Countries

Spain

Contacts

Public ContactSecretaria de Ginecologia Clínic

Fundació CLínic Recerca Biomèdica

secgine@clinic.cat34392275436

Outcome results

None listed

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