Long-term Use of Mifepristone in the Treatment of Adenomyosis
- Conditions
- AdenomyosisMifepristone
- Interventions
- Registration Number
- NCT05151016
- Brief Summary
The design was a prospective, randomized, positive-control, parallel-group, multicenter clinical trial. The study included a randomized, parallel-group treatment for 24 weeks in 140 subjects from eight hospitals in seven cities across the country who were diagnosed with Adenomyosis and associated symptoms (dysmenorrhea, with or without heavy menstrual flow) , the subjects were randomly assigned to the following two groups:
1. Study Group: mifepristone tablets, 10 mg, 1 tablet daily, taken orally (beginning on the third day of Menstruation) for 24 weeks;
2. Control Group: dafinil (Triptorelin Acetate) , 3.75 mg, first injection on the third day of menstruation, followed by intramuscular injection every 28 days for 24 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 140
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description mifepristone mifepristone mifepristone tablets，10mg，One tablet daily, oral treatment Triptorelin Acetate Triptorelin Acetate dafinil, 3.75 mg, first injection on the third day of menstruation, followed by intramuscular injection every 28 days for 24 weeks.
- Primary Outcome Measures
Name Time Method Change from Baseline in Pain on the Visual Analogue Scale (VAS) at week 24 Baseline and Week 24 The VAS is the most commonly used instrument assessing pain in clinical practice. It reflects the patient's subjective perception of pain. Possible scores range from 0 (no pain) to 10 (worst possible pain). The last observation carry forward was used for missing data.
Change=(Week 24 Score - Baseline Score)
- Secondary Outcome Measures
Name Time Method Pictorial blood loss assessment chart（PBAC） Baseline and week 24 Recording the use of tampons and sanitary towels by placing a tally mark under the day next to the box. Record clots by indicating whether they are the size of a 1p or 50pcoin in the clots/ flooding row under the relevant day. E.g. under day1 you may say 50p\*1 and 1p\*3. Record any incidences of flooding by placing a tally mark in the clots/ flooding row under the relevant day. A lightly stained towel (pic 1) will score 1 point, a moderately stained towel (pic 2) 5 points, a towel which is saturated with blood(pic 3) will score 20 points. A lightly stained tampon (pic 4) will score 1 point, a moderately stained tampon (pic 5) 5 points and a tampon that is fully saturated will score 10 points. A clot the size of 1p scores 1 point, a 50p sized clot scores 5 pointsand flooding also scores 5 points. Finally, total up the scores. A score of100 or greater may indicate a heavy period.
Change=Week 24 Score - Baseline ScoreChange from baseline in CA125 at week 24 Baseline and week 24 CA125 is measured in micrograms per liter. Change=(Week 24 Hemoglobin Content - Baseline Hemoglobin Content)
Change from baseline in hemoglobin at week 24 Baseline and week 24 Hemoglobin, measured in grams per liter, reflects a patient's level of menstrual blood loss.
Change=(Week 24 Hemoglobin Content - Baseline Hemoglobin Content)Change from baseline in uterine size at week 24 Baseline and week 24 Uterine size usually reflects the size of the adenomyosis lesion, and is measured in cubic centimeters.
Change=(Week 24 Uterine Size - Baseline Uterine Size)\*0.5236
Trial Locations
- Locations (1)
Women's Hospital of Zhejiang Medical University
🇨🇳Hangzhou, Zhejiang, China