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

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ClinicalTrials.gov Identifier: NCT03740945
Recruitment Status : Not yet recruiting
First Posted : November 14, 2018
Last Update Posted : March 8, 2019
Sponsor:
Collaborator:
AMAG Pharmaceuticals, Inc.
Information provided by (Responsible Party):
EndoCeutics Inc.

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.

Condition or disease Intervention/treatment Phase
Vaginal Atrophy in Breast Cancer Patients Drug: Placebo Drug: Prasterone (DHEA) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Prasterone

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo vaginal ovule daily for 12 weeks
Drug: Placebo
Daily administration of one placebo vaginal ovule at bedtime

Experimental: Prasterone
Prasterone (DHEA) vaginal ovule daily for 12 weeks
Drug: Prasterone (DHEA)
Daily administration of one prasterone vaginal ovule at bedtime
Other Name: Intrarosa




Primary Outcome Measures :
  1. Change from Baseline to Week 12 in the Percentage of Superficial Cells [ Time Frame: 12 weeks ]
  2. Change from Baseline to Week 12 in the Percentage of Parabasal Cells [ Time Frame: 12 weeks ]
  3. Change from Baseline to Week 12 in Vaginal pH [ Time Frame: 12 weeks ]
  4. Change from Baseline to Week 12 in Moderate/Severe VVA symptom being Most Bothersome (MBS) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change from Baseline to Week 12 in Moderate/Severe VVA symptom (not most bothersome) [ Time Frame: 12 weeks ]
  2. Change from Baseline to Week 12 on arousal/lubrication domain of Female Sexual Function Index (FSFI) questionnaire [ Time Frame: 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.

  3. Change from Baseline to Week 12 on subjective arousal domain of FSFI [ Time Frame: 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.

  4. Change from Baseline to Week 12 on desire domain of FSFI [ Time Frame: 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.

  5. Change from Baseline to Week 12 on satisfaction domain of FSFI [ Time Frame: 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.

  6. Change from Baseline to Week 12 on orgasm domain of FSFI [ Time Frame: 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.

  7. Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions [ Time Frame: 12 weeks ]
    Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy.

  8. Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness [ Time Frame: 12 weeks ]
    Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy.

  9. Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity [ Time Frame: 12 weeks ]
    Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy.

  10. Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color [ Time Frame: 12 weeks ]
    Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy.



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740945


Contacts
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Contact: Isabelle Côté 1-855-653-0033 ext 204 isabelle.cote@endoceutics.com

Sponsors and Collaborators
EndoCeutics Inc.
AMAG Pharmaceuticals, Inc.
Investigators
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Study Chair: Claude Labrie, M.D., Ph.D. Endoceutics, Inc., Quebec, Canada
Principal Investigator: David F Archer, M.D. Jones Institute, Norfolk VA 23507
Principal Investigator: Sheryl Kingsberg, Ph.D. MacDonald Women's Hospital, Cleveland, OH 44106 USA

Publications of Results:

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Responsible Party: EndoCeutics Inc.
ClinicalTrials.gov Identifier: NCT03740945     History of Changes
Other Study ID Numbers: ERC-260
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by EndoCeutics Inc.:
Vulvovaginal atrophy (VVA)
Vaginal atrophy
Atrophic vaginitis
Prasterone
DHEA
Intrarosa
Breast cancer
Aromatase inhibitor

Additional relevant MeSH terms:
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Breast Neoplasms
Atrophy
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pathological Conditions, Anatomical
Aromatase Inhibitors
Dehydroepiandrosterone
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors