Tokyo, March 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060901) titled 'Effects of Menstrual Cycle-Related Sex Hormone Fluctuations on Joint Laxity and Structural Properties' on March 11.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Niigata University of Health and Welfare

Condition: Condition - healthy adult women Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to clarify the effects of menstrual cycle phases and fluctuations in sex hormone concentrations on local joint laxity (elbow joint and foot) and joint deformity in healthy adult women. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - To evaluate menstrual cycle-related variations, joint stability, and sex hormone concentrations, assessments will be conducted at two time points: the early follicular phase and the ovulatory phase. Joint stability will be evaluated using an ultrasound imaging system according to the method described in a previous study. For the elbow and foot joints, joint space distance will be measured under a standardized mechanical load using a dedicated stress device.

In addition, saliva samples will be collected using saliva collection kits, and salivary sex hormone concentrations will be measured.

Foot morphology will be assessed using a three-dimensional foot scanning system. The hallux valgus angle, fifth-toe varus angle, and medial longitudinal arch height will be measured under two conditions: weight-bearing and non-weight-bearing. Furthermore, the carrying angle of the elbow joint will be measured using a goniometer. These alignment measurements will be performed once.

Eligibility: Age-lower limit - 18 years-old = Gender - Female Key inclusion criteria - women with normal menstrual cycles Key exclusion criteria - women with menstrual irregularities or amenorrhea Target Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 16 Day Anticipated trial start date - 2026 Year 01 Month 16 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=R000069422

Disclaimer: Curated by HT Syndication.