Vaginal Atrophy in Breast Cancer Patients Clinical Trial
Official title:
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)
| Verified date | July 2020 |
| Source | EndoCeutics Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | December 5, 2019 |
| Est. primary completion date | December 5, 2019 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 30 Years to 80 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| EndoCeutics Inc. | AMAG Pharmaceuticals, Inc. |
Archer DF, Labrie F, Bouchard C, Portman DJ, Koltun W, Cusan L, Labrie C, Côté I, Lavoie L, Martel C, Balser J; VVA Prasterone Group. Treatment of pain at sexual activity (dyspareunia) with intravaginal dehydroepiandrosterone (prasterone). Menopause. 2015 — View Citation
Ke Y, Labrie F, Gonthier R, Simard JN, Bergeron D, Martel C, Vaillancourt M, Montesino M, Lavoie L, Archer DF, Balser J, Moyneur E; other participating Members of the Prasterone Clinical Research Group. Serum levels of sex steroids and metabolites followi — View Citation
Labrie F, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Côté I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur É; VVA Prasterone Research Group. Efficacy of intravaginal dehydroepiandrosterone ( — View Citation
Labrie F, Archer DF, Martel C, Vaillancourt M, Montesino M. Combined data of intravaginal prasterone against vulvovaginal atrophy of menopause. Menopause. 2017 Nov;24(11):1246-1256. doi: 10.1097/GME.0000000000000910. — View Citation
Labrie F, Derogatis L, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Côté I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur É; Members of the VVA Prasterone Research Group. Effect of Intravagina — View Citation
Labrie F, Montesino M, Archer DF, Lavoie L, Beauregard A, Côté I, Martel C, Vaillancourt M, Balser J, Moyneur E; other participating Members of the Prasterone Clinical Research Group. Influence of treatment of vulvovaginal atrophy with intravaginal praste — View Citation
Martel C, Labrie F, Archer DF, Ke Y, Gonthier R, Simard JN, Lavoie L, Vaillancourt M, Montesino M, Balser J, Moyneur É; other participating members of the Prasterone Clinical Research Group. Serum steroid concentrations remain within normal postmenopausal — View Citation
Montesino M, Labrie F, Archer DF, Zerhouni J, Côté I, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Moyneur E, Balser J. Evaluation of the acceptability of intravaginal prasterone ovule administration using an applicator. Gynecol Endocrinol. 2016;32(3 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from Baseline to Week 12 in the Percentage of Superficial Cells | 12 weeks | ||
| Primary | Change from Baseline to Week 12 in the Percentage of Parabasal Cells | 12 weeks | ||
| Primary | Change from Baseline to Week 12 in Vaginal pH | 12 weeks | ||
| Primary | Change from Baseline to Week 12 in Moderate/Severe VVA symptom being Most Bothersome (MBS) | 12 weeks | ||
| Secondary | Change from Baseline to Week 12 in Moderate/Severe VVA symptom (not most bothersome) | 12 weeks | ||
| Secondary | Change from Baseline to Week 12 on arousal/lubrication domain of Female Sexual Function Index (FSFI) questionnaire | 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. | 12 weeks | |
| Secondary | Change from Baseline to Week 12 on subjective arousal domain of FSFI | 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. | 12 weeks | |
| Secondary | Change from Baseline to Week 12 on desire domain of FSFI | 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. | 12 weeks | |
| Secondary | Change from Baseline to Week 12 on satisfaction domain of FSFI | 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. | 12 weeks | |
| Secondary | Change from Baseline to Week 12 on orgasm domain of FSFI | 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. | 12 weeks | |
| Secondary | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy. | 12 weeks | |
| Secondary | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness | Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy. | 12 weeks | |
| Secondary | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy. | 12 weeks | |
| Secondary | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy. | 12 weeks |