Tokyo, Nov. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059653) titled 'E4-YBONE Study: Estetrol and Bone Metabolism in Young Women' on Nov. 15.
Study Type:
Observational
Primary Sponsor:
Institute - Yokohama city University
Condition:
Condition - Dysmenorrhea
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the efficacy and safety of an E4-containing LEP formulation on bone metabolism in young women.
Basic objectives2 - Safety
Eligibility:
Age-lower limit - 15
years-old
=
Gender - Female
Key inclusion criteria - Patients diagnosed with dysmenorrhea
Female patients aged 15 to 22 years who are at least 3 years after menarche
Patients who can provide written informed consent
Key exclusion criteria - Patients with a history of treatment with low-dose estrogen-progestin preparations for dysmenorrhea
Patients with a history of treatment with hormonal agents other than LEP preparations
Patients with a history of treatment with bone metabolism drugs
Patients with contraindications to estetrol-containing low-dose LEP preparations
Target Size - 80
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 30 Day
Anticipated trial start date - 2025 Year 12 Month 01 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068236
Disclaimer: Curated by HT Syndication.
