Trial · NCT01817530
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month | Baseline, Final Month (last 28 days of treatment) | The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL Volume of \< 80 mL at the Final Month and a ≥50% Reduction in MBL Volume from Baseline to the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period. |
| Secondary | Percentage of Participants With a MBL Volume < 80 mL and a ≥ 50% Reduction in MBL Volume From Baseline During the Last 56 to 29 Days of Treatment | Baseline, second last 28 days of treatment (last 56 to 29 days of treatment) | The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL volume \< 80 mL and a ≥ 50% reduction in MBL volume from baseline during the last 56 to 29 days of last treatment. Baseline is defined as the last qualified menstrual cycle during the screening period. |
| Secondary | Percentage of Participants With a MBL Volume < 80 mL and a ≥ 50% Reduction in MBL Volume From Baseline During the Last 84 to 57 Days of Treatment | Baseline, third last 28 days of treatment (last 84 to 57 days of treatment) | The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL volume \< 80 mL and a ≥ 50% reduction in MBL volume from baseline during the last 84 to 57 days of last treatment. Baseline is defined as the last qualified menstrual cycle during the screening period. |
| Secondary | Percentage of Participants Who Achieved an MBL Volume of < 80 mL at the Final Month | Final Month (last 28 days of treatment) | Percentage of participants who achieved an MBL volume of \< 80 mL at the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period. |
| Secondary | Percentage of Participants With a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month | Baseline, Final Month (last 28 days of treatment) | Percentage of participants with a \>= 50% reduction from baseline in MBL to the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period. |
| Secondary | Percentage of Participants Who Achieved Amenorrhea During the Last 56 Days of Treatment | Last 56 days of treatment (after 10 days from first dose date) | Amenorrhea is defined as having 0 days of bleeding or spotting based on observed validated and nonvalidated alkaline hematin data and having 0 days of bleeding or spotting, based on imputed electronic diary data during the last 56 days of treatment. Participants needed to have at least 66 days on treatment. |
| Secondary | Percentage of Participants Who Achieved Suppression of Bleeding During the Last 56 Days of Treatment | Last 56 days of treatment (after 10 days from first dose date) | Suppression of bleeding is defined as having 0 days of bleeding based on observed validated and nonvalidated alkaline hematin data and having 0 days of bleeding (spotting is allowed) based on imputed electronic diary data during the last 56 days of treatment. |
| Secondary | Mean Change in the Number of Bleeding Days From Baseline to Month 6 | Baseline, Month 6 | The number of days with any bleeding including spotting was calculated using data collected on daily bleeding diary. Baseline is defined as the last 28 days prior to the first dose day of study drug. |
| Secondary | Mean Change in the Number of Heavy Bleeding Days From Baseline to Month 6 | Baseline, Month 6 | The number of days with heavy bleeding (either heavy or very heavy/gushing bleeding) was calculated using data collected on daily bleeding diary. Baseline is defined as the last 28 days prior to the first dose day of study drug. |
| Secondary | Change in Bleeding Severity Scores From Baseline at the Final Month | Baseline, Final Month (last 28 days of treatment) | The average bleeding score was calculated for each 28-day interval starting on Day 29 using data collected on daily bleeding diary using the Mansfield-Voda-Jorgenson (MVJ) Menstrual Bleeding Scale (1=spotting, 2 = very light bleeding, 3 = light bleeding, 4 = moderate bleeding, 5 = heavy bleeding, 6 = very heavy/gushing bleeding). Baseline is defined as the last 28 days prior to the first day of study drug. |
| Secondary | Mean Change in Hemoglobin Concentration From Baseline to Final Visit | Baseline, Final Visit during treatment period (Month 6 or early termination) | Baseline is defined as the last measurement prior to the first dose of study drug. |
| Secondary | Mean Percentage Change From Baseline in Total Fibroid Volume at Month 3, Month 6, and Final Visit | Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination) | Volume of the total fibroid volume (3 largest fibroids), as measured by transvaginal ultrasound, or transabdominal ultrasound. |
| Secondary | Mean Percentage Change From Baseline in Primary Fibroid Volume at Month 3, Month 6, and Final Visit | Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination) | Volume of the largest fibroid (primary fibroid), as measured by transvaginal ultrasound, or transabdominal ultrasound. |
| Secondary | Mean Percentage Change From Baseline in Uterine Volume at Month 3, Month 6, and Final Visit | Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination) | Uterine volume, as measured by transvaginal ultrasound or transabdominal ultrasound. |
| Secondary | Percentage of Participants With ≥ 25% Reduction From Baseline in Total Fibroid Volume at Month 3, Month 6, and Final Visit | Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination) | Total fibroid volume (3 largest fibroids) was measured by transvaginal ultrasound, or transabdominal ultrasound. |
| Secondary | Percentage of Participants With ≥ 25% Reduction From Baseline in Primary Fibroid Volume at Month 3, Month 6, and Final Visit | Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination) | Volume of the largest fibroid (primary fibroid) was measured by transvaginal ultrasound or transabdominal ultrasound. |
| Secondary | Percentage of Participants With ≥ 25% Reduction From Baseline in Uterine Volume at Month 3, Month 6, and Final Visit | Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination) | Uterine volume was measured by transvaginal ultrasound or transabdominal ultrasound. |
| Secondary | Change From Baseline to Each Month in Non-Bleeding Uterine Fibroids Symptom (NBUFSQ) Questionnaire | Baseline, Days 1-28, Days 29-56, Days 57-84, Days 85-112, Days 113-140, Days 141-168, Final Month of treatment, Post-treatment (PT) Days 1-28, PT Days 29-56, PT Days 57-84, PT Days 85-112, PT Days 113-140, PT Days 141-168 | The NBUFSQ (8 items) is a brief patient-reported daily diary that assesses non-bleeding symptoms experienced by women with uterine fibroids. It includes 6 items, asking women to rate their symptoms (abdominal/pelvic pain, pressure, and cramping, back pain, bloating, and urinary problems) in the past 24 hours using an 11-point numeric response scale that ranges from 0 (i.e., no symptom) to 10 (i.e., worst possible symptom) and 2 items to address urinary frequency during the daytime and at night. Data presented in the sum of scores to the 6 symptom questions, ranging from 0 (no symptoms) to 60 (worst possible symptoms). Baseline is defined as the last 28 days prior to the first day of study drug. Final Month is defined as the last 28 days prior to and including the last dose date of study drug. |
| Secondary | Percentage of Participants Who Successfully Avoided Surgical or Invasive Procedures for Uterine Fibroids | Month 6 | The percentage of participants who successfully avoided surgical or invasive procedures for Uterine Fibroids was assessed. |
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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