MJR-35 long-term study

Phase 3

Completed

• Conditions: Dysmenorrhea

• Registration Number: JPRN-jRCT2080223493
• Lead Sponsor: MOCHIDA PHARMACEUTICAL CO., LTD.

Brief Summary

This study showed favorable tolerability of the long-term use of MJR-35 to patients with dysmenorrhea and a sustainable pain relief effect.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-27
• Study Completion: 2019-05-31
• Results First Posted: 2020-04-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: Female
• Target Recruitment: 147

Inclusion Criteria

(1)Patients who have a painful symptom (lower abdominal pain or lumber pain) that were considered to be originated in dysmenorrhea in a degree of 3 points or more of dysmenorrhea score
(2)Patients diagnosed with dysmenorrhea
(3)Regular menstrual cycle length within 38 days

Exclusion Criteria

(1)Patient with a complication of submucosal myoma
(2)Patients with a complication of lower abdominal pain or lumber pain which they can not judge whether due to dysmenorrhea or not
(3)Patients with a remarkable uterus swelling
(4)Patients with undiagnosed abnormal genital bleeding, endometrial polyp, uterine deformity or endometrial hyperplasia
(5)Patients with severe anemia
etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified