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

NCT03740945 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: ERC-260
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vaginal Atrophy in Breast Cancer Patients

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• Change from Baseline to Week 12 in Moderate/Severe VVA symptom (not most bothersome)

  12 weeks

• Change from Baseline to Week 12 on arousal/lubrication domain of Female Sexual Function Index (FSFI) questionnaire

  12 weeks

• Change from Baseline to Week 12 on subjective arousal domain of FSFI

  12 weeks

• Change from Baseline to Week 12 on desire domain of FSFI

  12 weeks

• Change from Baseline to Week 12 on satisfaction domain of FSFI

  12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo vaginal ovule daily for 12 weeks

Drug: Placebo

Prasterone

EXPERIMENTAL

Prasterone (DHEA) vaginal ovule daily for 12 weeks

Drug: Prasterone (DHEA)

Interventions

Placebo DRUG

Daily administration of one placebo vaginal ovule at bedtime

Placebo

Prasterone (DHEA) DRUG

Daily administration of one prasterone vaginal ovule at bedtime

Also known as: Intrarosa

Prasterone

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Main criteria:
• 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.
• Women between 30 and 80 years of age
• Women having ≤5% of superficial cells on vaginal smear at baseline
• Women having a vaginal pH above 5 at baseline
• Women who have self-identified moderate or severe symptom(s) of vaginal atrophy

You may not qualify if:

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

Sponsors & Collaborators

• EndoCeutics Inc.: lead
• AMAG Pharmaceuticals, Inc.: collaborator

Related Publications (8)

• 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 following 12 weeks of intravaginal 0.50% DHEA administration. J Steroid Biochem Mol Biol. 2015 Nov;154:186-96. doi: 10.1016/j.jsbmb.2015.08.016. Epub 2015 Aug 17.

  PMID: 26291918 RESULT

• Labrie F, Derogatis L, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Cote I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur E; Members of the VVA Prasterone Research Group. Effect of Intravaginal Prasterone on Sexual Dysfunction in Postmenopausal Women with Vulvovaginal Atrophy. J Sex Med. 2015 Dec;12(12):2401-12. doi: 10.1111/jsm.13045. Epub 2015 Nov 23.

  PMID: 26597311 RESULT

• Labrie F, Montesino M, Archer DF, Lavoie L, Beauregard A, Cote 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 prasterone on the male partner. Climacteric. 2015;18(6):817-25. doi: 10.3109/13697137.2015.1077508. Epub 2015 Oct 30.

  PMID: 26517756 RESULT

• Labrie F, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Cote I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur E; VVA Prasterone Research Group. Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause. Menopause. 2016 Mar;23(3):243-56. doi: 10.1097/GME.0000000000000571.

  PMID: 26731686 RESULT

• Martel C, Labrie F, Archer DF, Ke Y, Gonthier R, Simard JN, Lavoie L, Vaillancourt M, Montesino M, Balser J, Moyneur E; other participating members of the Prasterone Clinical Research Group. Serum steroid concentrations remain within normal postmenopausal values in women receiving daily 6.5mg intravaginal prasterone for 12 weeks. J Steroid Biochem Mol Biol. 2016 May;159:142-53. doi: 10.1016/j.jsbmb.2016.03.016. Epub 2016 Mar 10.

  PMID: 26972555 RESULT

• Montesino M, Labrie F, Archer DF, Zerhouni J, Cote 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):240-5. doi: 10.3109/09513590.2015.1110140. Epub 2016 Jan 6.

  PMID: 26634942 RESULT

• Archer DF, Labrie F, Bouchard C, Portman DJ, Koltun W, Cusan L, Labrie C, Cote I, Lavoie L, Martel C, Balser J; VVA Prasterone Group. Treatment of pain at sexual activity (dyspareunia) with intravaginal dehydroepiandrosterone (prasterone). Menopause. 2015 Sep;22(9):950-63. doi: 10.1097/GME.0000000000000428.

  PMID: 25734980 RESULT

• 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.

  PMID: 28640161 RESULT

MeSH Terms

Conditions

Atrophic Vaginitis; Breast Neoplasms

Interventions

Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; 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

• Claude Labrie, M.D., Ph.D.

  Endoceutics, Inc., Quebec, Canada

  STUDY CHAIR

• David F Archer, M.D.

  Jones Institute, Norfolk VA 23507

  PRINCIPAL INVESTIGATOR

• Sheryl Kingsberg, Ph.D.

  MacDonald Women's Hospital, Cleveland, OH 44106 USA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 14, 2018
• Study Start: November 6, 2018
• Primary Completion: December 5, 2019
• Study Completion: December 5, 2019
• Last Updated: July 31, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share