Effect of Intravaginal Prasterone on Symptoms of VVA in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer

Effect of Intravaginal Prasterone (DHEA) on Moderate to Severe Symptoms of Vulvovaginal Atrophy Due to Menopause, in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer - (Placebo-Controlled, Double Blind and Randomized Phase III Study)

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03740945

Enrollment

Registered

2018-11-14

Start date

2018-11-06

Completion date

2019-12-05

Last updated

2020-07-31

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

Conditions

Vaginal Atrophy in Breast Cancer Patients

Keywords

Vulvovaginal atrophy (VVA), Vaginal atrophy, Atrophic vaginitis, Prasterone, DHEA, Intrarosa, Breast cancer, Aromatase inhibitor

Brief summary

The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on moderate to severe (MS) and most bothersome symptoms (MBS) of vulvovaginal atrophy (VVA) due to natural, surgical or treatment-induced menopause, in women with breast cancer who are under treatment with an aromatase inhibitor.

Interventions

DRUGPlacebo

Daily administration of one placebo vaginal ovule at bedtime

DRUGPrasterone (DHEA)

Daily administration of one prasterone vaginal ovule at bedtime

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 80 Years

Healthy volunteers

Inclusion criteria

Main criteria: 1. Natural, surgically- or treatment-induced postmenopausal women (non hysterectomized or hysterectomized) with breast cancer (stage 1 or 2) who is currently under treatment with an aromatase inhibitor and will remain on that treatment for the duration of the study. 2. Women between 30 and 80 years of age 3. Women having ≤5% of superficial cells on vaginal smear at baseline 4. Women having a vaginal pH above 5 at baseline 5. Women who have self-identified moderate or severe symptom(s) of vaginal atrophy

Exclusion criteria

Main criteria: 1. Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication 2. The administration of any investigational drug within 30 days of screening visit

Design outcomes

Primary

Measure	Time frame
Change from Baseline to Week 12 in the Percentage of Superficial Cells	12 weeks
Change from Baseline to Week 12 in the Percentage of Parabasal Cells	12 weeks
Change from Baseline to Week 12 in Vaginal pH	12 weeks
Change from Baseline to Week 12 in Moderate/Severe VVA symptom being Most Bothersome (MBS)	12 weeks

Secondary

Measure	Time frame	Description
Change from Baseline to Week 12 on satisfaction domain of FSFI	12 weeks	Individual domain score will be obtained by adding the scores of the individual questions that comprise the domain and multiplying the sum by the domain factor.
Change from Baseline to Week 12 on orgasm domain of FSFI	12 weeks	Individual domain score will be obtained by adding the scores of the individual questions that comprise the domain and multiplying the sum by the domain factor.
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions	12 weeks	Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy.
Change from Baseline to Week 12 in Moderate/Severe VVA symptom (not most bothersome)	12 weeks	—
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity	12 weeks	Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy.
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color	12 weeks	Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy.
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness	12 weeks	Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy.
Change from Baseline to Week 12 on arousal/lubrication domain of Female Sexual Function Index (FSFI) questionnaire	12 weeks	Individual domain score will be obtained by adding the scores of the individual questions that comprise the domain and multiplying the sum by the domain factor.
Change from Baseline to Week 12 on subjective arousal domain of FSFI	12 weeks	Individual domain score will be obtained by adding the scores of the individual questions that comprise the domain and multiplying the sum by the domain factor.
Change from Baseline to Week 12 on desire domain of FSFI	12 weeks	Individual domain score will be obtained by adding the scores of the individual questions that comprise the domain and multiplying the sum by the domain factor.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026