Clinical Trial: Adenomyosis and Ulipristal Acetate

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Pilot Phase II, Randomized , and Control in Double Blind Placebo Effectiveness a 3 Months on Bleeding Fibroids Treatment With ULIPRISTAL ACETATE 10 mg/Day in Patients Suffering From Symptomatic Endome

Brief Summary: Evaluation of efficiency of selective progesterone receptor modulators (SPRM) (Ulipristal acetate) on bleeding control and pain for patients with adenomyosis and wish to keep fertility.

Detailed Summary:

After inclusion according to criteria, 2 arms : placebo and Ulipristal acetate (UA) 10mg with randomisation, 1 patient with placebo for 3 patients with UA.

48 patients will be included in this trial. The end point will be the bleeding evaluated by Pictorial Blood-loss Assessment Chart (PBAC) score, the amenorrhea rate and the pain evaluated with visual analogic scale.


Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: 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) [ Time Frame: after 12 weeks of treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Evolution of the PBAC score over 28 days compared to pre-treatment score (J1) [ Time Frame: at week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment ]
  • Percentage of patients with uterine bleeding control estimated by a score of PBAC < 75 on 28 days [ Time Frame: at week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1) ]
  • 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; [ Time Frame: at Day 29 ]
  • percentage of patients with amenorrhea estimated by a score of PBAC ≤2 on 28 days [ Time Frame: to week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1) ]
  • Evolution of the PBAC score calculated from the sum on the 28 days during the treatment period for the first day of amenorrhea [ Time Frame: for the first day of amenorrhea after the treatment ]
  • Evolution of pain through a Visual scale analogue between J1 and S5 (J29) S13 (J85) and M6 (S26 S28), [ Time Frame: between day1 (before treatment) and week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1) ]
  • 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 [ Time Frame: between day1 (before treatment) and week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1) ]
  • Evolution quality of life questionnaire with Uterine Fibroid Symptom and health related Quality of Life (UFS - QOL) questionnaire [ Time Frame: between day1 (before treatment) and week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1) ]
  • Evolution of anemia by hemoglobin and ferritin concentration and coagulation by the CAW [ Time Frame: between day1 (before treatment) and week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1) ]
  • Evaluation of the adenomyosis by MRI or ultrasound transvaginal : existence/absence, focal length/diffuse, shallow/deep [ Time Frame: Before the treatment and 6 months after beginning of the treatment ]
  • blood pressure and heart rate, respiratory rate [ Time Frame: Before the treatment and up to 6 months after beginning of the treatment ]
  • Number of participants with adverse events and their grades as assessed by CTCAE v4.0 [ Time Frame: Before the treatment and up to 6 months after beginning of the treatment ]
  • biological examinations: hemoglobin, ferritin, TCA. [ Time Frame: Before the treatment and up to 6 months after beginning of the treatment ]
    Safety assessment
  • Frequency of flashes of heat, headache, thickening of the endometrium, uterine bleeding, ovarian cyst. [ Time Frame: Before the treatment and up to 6 months after beginning of the treatment ]


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: May 29, 2015
Date Started: May 2015
Date Completion: November 2017
Last Updated: March 21, 2017
Last Verified: October 2016