Spots Global Cancer Trial Database for Effect of Intravaginal Prasterone on Symptoms of VVA in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer
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Trial Identification
Brief Title: Effect of Intravaginal Prasterone on Symptoms of VVA in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer
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)
Study ID: NCT03740945
Study Description
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.
Detailed Description:
Eligibility
Minimum Age: 30 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Contact Details
Name: Claude Labrie, M.D., Ph.D.
Affiliation: Endoceutics, Inc., Quebec, Canada
Role: STUDY_CHAIR
Name: David F Archer, M.D.
Affiliation: Jones Institute, Norfolk VA 23507
Role: PRINCIPAL_INVESTIGATOR
Name: Sheryl Kingsberg, Ph.D.
Affiliation: MacDonald Women's Hospital, Cleveland, OH 44106 USA
Role: PRINCIPAL_INVESTIGATOR
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