Trial · NCT01422408
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Symptom Scores of Vaginal Dryness | Baseline and 4 weeks | Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Primary | Change in Symptom Scores of Dyspareunia | Baseline and 4 weeks | Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Secondary | Change in Symptom Scores of Vaginal Itching | Baseline and 4 weeks | Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Secondary | Change in Total Vaginal Index Score. | Baseline and 4 weeks | Change in total vaginal index score. The total vaginal index score is a numerical value ranging from zero to twelve, comprised of the three components of vaginal dryness, vaginal itching, and dyspareunia graded on an ordinal scale of zero to four added together. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -12 to +12; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints. |
| Secondary | Number of Patients Experiencing Toxicities | Over 4 weeks | Toxicity data will be reported as descriptive data as the percentage of patients experiencing reported side effects. Toxicity and safety analyses will be conducted using the safety analysis set. |
| Secondary | Change in Vaginal Dryness Symptom Scores by Age Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Dryness and Age) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Secondary | Change in Dyspareunia Symptom Scores by Age Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Dyspareunia and Age) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Secondary | Change in Vaginal Itching Symptom Scores by Age Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Itching and Age) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Secondary | Change in Vaginal Dryness Symptom Scores by Menopause Status Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Dryness and Menopause status) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Secondary | Change in Dyspareunia Symptom Scores by Menopause Status Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Dyspareunia and Menopause status) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Secondary | Change in Vaginal Itching Symptom Scores by Menopause Status Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Itching and Menopause status) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Secondary | Change in Vaginal Dryness Symptom Scores by Current Endocrine Therapy Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Dryness and current endocrine therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Secondary | Change in Dyspareunia Symptom Scores by Current Endocrine Therapy Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Dyspareunia and current endocrine therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Secondary | Change in Vaginal Itching Symptom Scores by Current Endocrine Therapy Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Itching and current endocrine therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Secondary | Change in Vaginal Dryness Symptom Scores by Prior Cytotoxic Therapy Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Dryness and prior cytotoxic therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Secondary | Change in Dyspareunia Symptom Scores by Prior Cytotoxic Therapy Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Dyspareunia and prior cytotoxic therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Secondary | Change in Vaginal Itching Symptom Scores by Prior Cytotoxic Therapy Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Itching and prior cytotoxic therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Secondary | Change in Vaginal Dryness Symptom Scores by Indication for Endocrine Therapy Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Dryness and Indications) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Secondary | Change in Dyspareunia Symptom Scores by Indication for Endocrine Therapy Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Dyspareunia and Indications) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
| Secondary | Change in Vaginal Itching Symptom Scores by Indication for Endocrine Therapy Characteristics | Baseline and 4 weeks | Association of response in symptoms with characteristics of the subject population (Itching and Indications) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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