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Vaginal DHEA for Vaginal Symptoms: A Phase III Randomized, Double Blind, Placebo- Controlled Trial
Provider Data DescriptionDataset NCT01376349-D1-Dataset.csv (consort) is one of 6 datasets associated with PubMed ID 28921241. This dataset contains information regarding whether patients were included in the primary analysis.
At the time of publication, 353 (Placebo=118; DHEA 3.25 mg=123; DHEA 6.5 mg=112) patients were used in the primary analysis. The updated data in NCT01376349-D1-Dataset includes a variable ?endpoint? which identifies which patients are currently evaluable for the primary endpoint based on updated data. This includes 344 (Placebo=108; DHEA 3.25 mg=123; DHEA 6.5 mg=113).
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Dehydroepiandrosterone (DHEA) may help relieve vaginal symptoms in female cancer survivors.
PURPOSE: This randomized phase III trial studies DHEA to see how well it works compared to placebo in treating postmenopausal cancer survivors with vaginal symptoms.
ConditionsBreast Cancer Gynecologic Cancer
Intervention TypeDrug: prasterone Other: placebo
Arms InterventionArm I low dose DHEA - Experimental Arm II high dose DHEA - Experimental Arm III placebo - Placebo Comparator
Collaborator(s)National Cancer Institute (NCI) Mayo Clinic
Age Range18 Years and older (Adult, Older Adult)