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Type(s) of Cancer
Breast, Gynecological
Study Phase
Phase 3
Study Completion Date
2013-08
NCT01376349Uploaded 08-21-2021
Access via NCI by Request
PDS UID: nci-data-483
Vaginal DHEA for Vaginal Symptoms: A Phase III Randomized, Double Blind, Placebo- Controlled Trial
Provider Information
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
Drug(s)Drug: prasterone
Total Enrolled464
RandomizationRandomized
Blinding MethodDouble
Arms InterventionArm I low dose DHEA - Experimental
Arm II high dose DHEA - Experimental
Arm III placebo - Placebo Comparator
Secondary IDNCCTG-N10C1
PubMed (PMID)N/A
Collaborator(s)National Cancer Institute (NCI)
Mayo Clinic
Region(s)United States
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT01376349-D1
Data DictionaryNCT01376349-D1-Data-Dictionary_3.pdf
DATANCT01376349-D1-Dataset_3.csv
OTHERREADME.pdf
Files: NCT01376349-D2
Data DictionaryNCT01376349-D2-Data-Dictionary_3.pdf
DATANCT01376349-D2-Dataset_2.csv
OTHERREADME.pdf
Files: NCT01376349-D3
Data DictionaryNCT01376349-D3-Data-Dictionary_3.pdf
DATANCT01376349-D3-Dataset_2.csv
OTHERREADME.pdf
Files: NCT01376349-D4
Data DictionaryNCT01376349-D4-Data-Dictionary_3.pdf
DATANCT01376349-D4-Dataset_2.csv
OTHERREADME.pdf
Files: NCT01376349-D5
Data DictionaryNCT01376349-D5-Data-Dictionary_3.pdf
DATANCT01376349-D5-Dataset_2.csv
OTHERREADME.pdf
Files: NCT01376349-D6
Data DictionaryNCT01376349-D6-Data-Dictionary_2.pdf
DATANCT01376349-D6-Dataset_3.csv
OTHERREADME.pdf
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