NCT01376349

Clinical Trial Information


Trial Number: NCT01376349 (ClinicalTrials.gov)
Disease Type:
  • Breast Neoplasm - Miscellaneous
  • Reproductive System Neoplasm, Female - Miscellaneous
Trial Title:
Vaginal DHEA for Vaginal Symptoms: A Phase III Randomized, Double Blind, Placebo- Controlled Trial
Study ID:
NCCTG-N10C1
Images are available?:
No
Is this a NCI-MATCH Trial?:
No


Datasets Linked to Trial

Title Description
NCT01376349-D6 Dataset NCT01376349-D6-Dataset.csv (AE) is one of 6 datasets associated with PubMed ID 28921241. This dataset contains all reported adverse events during treatment.
NCT01376349-D5 Dataset NCT01376349-D5-Dataset.csv (table3) is one of 6 datasets associated with PubMed ID 28921241. This dataset contains information that will allow you to reproduce Table 3. Mean scores and change from baseline for select Female Sexual Function Index (FSFI) subscales and quality of life (QOL).
NCT01376349-D4 Dataset NCT01376349-D4-Dataset.csv (table2) is one of 6 datasets associated with PubMed ID 28921241. This dataset contains information that will allow you to reproduce Table 2. Change from Baseline to 12 weeks in self-reported side effects. Negative changes indicate worsening symptoms.
NCT01376349-D3 Dataset NCT01376349-D3-Dataset.csv (table1) is one of 6 datasets associated with PubMed ID 28921241. This dataset contains information that will allow you to reproduce Table 1. Baseline demographic and treatment characteristics.
NCT01376349-D2 Dataset NCT01376349-D2-Dataset.csv (figure2) is one of 6 datasets associated with PubMed ID 28921241. This dataset contains information that will allow you to reproduce Figure 2, the mean change in severity of dryness or dyspareunia over 12 weeks.
NCT01376349-D1 Dataset 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).