Trial · NCT02587000
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of patients with a control uterine bleeding estimated by a score of Pictorial Blood-loss Assessment Chart (PABC) < 75 of 28 days to the discontinuation of the study (S13) | after 12 weeks of treatment | |
| Secondary | Evolution of the PBAC score over 28 days compared to pre-treatment score (J1) | at week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment | |
| Secondary | Percentage of patients with uterine bleeding control estimated by a score of PBAC < 75 on 28 days | at week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1) | |
| Secondary | Evolution of the PBAC score calculated from the sum on the 28 days during the treatment period for the first day of control of uterine bleeding; | at Day 29 | |
| Secondary | percentage of patients with amenorrhea estimated by a score of PBAC ≤2 on 28 days | to week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1) | |
| Secondary | Evolution of the PBAC score calculated from the sum on the 28 days during the treatment period for the first day of amenorrhea | for the first day of amenorrhea after the treatment | |
| Secondary | Evolution of pain through a Visual scale analogue between J1 and S5 (J29) S13 (J85) and M6 (S26 S28), | between day1 (before treatment) and week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1) | |
| Secondary | Evolution of analgesics using between each visit (number of days of treatment and the percentage of patients without analgesic over each period of 28 days of collection of the PBAC) and by bearing the information provided by the investigator | between day1 (before treatment) and week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1) | |
| Secondary | Evolution quality of life questionnaire with Uterine Fibroid Symptom and health related Quality of Life (UFS - QOL) questionnaire | between day1 (before treatment) and week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1) | |
| Secondary | Evolution of anemia by hemoglobin and ferritin concentration and coagulation by the CAW | between day1 (before treatment) and week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1) | |
| Secondary | Evaluation of the adenomyosis by MRI or ultrasound transvaginal : existence/absence, focal length/diffuse, shallow/deep | Before the treatment and 6 months after beginning of the treatment | |
| Secondary | blood pressure and heart rate, respiratory rate | Before the treatment and up to 6 months after beginning of the treatment | |
| Secondary | Number of participants with adverse events and their grades as assessed by CTCAE v4.0 | Before the treatment and up to 6 months after beginning of the treatment | |
| Secondary | biological examinations: hemoglobin, ferritin, TCA. | Before the treatment and up to 6 months after beginning of the treatment | Safety assessment |
| Secondary | Frequency of flashes of heat, headache, thickening of the endometrium, uterine bleeding, ovarian cyst. | Before the treatment and up to 6 months after beginning of the treatment |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT02587000/registered