NCT07112651

Efficacy of CL25216 on Vasomotor Symptoms in Women During Perimenopause

The Effects of CL25216 on Vasomotor Symptoms in Women During Perimenopause: a Randomised, Double-blind, Placebo-controlled Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: ApexCPG LLC · Industry
• Sex: Female
• Age: 40 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is to evaluate the effects of CL25216 on vasomotor symptoms in women during Perimenopause. Enrolled subjects will receive either CL25216 - 250 mg/day or placebo.

Detailed description

The purpose of this study is to evaluate the effects of CL25216 on vasomotor symptoms in women during perimenopause. A total of 80 female aged between40-55 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer-generated randomization list. The subjects will be assigned to either CL25216 - 250 mg or placebo arms at 1:1ratio. The subjects will be instructed to take one capsule a day after breakfast for 105 days. Apart from primary and secondary outcomes, the study will also record the vital signs and adverse events to evaluate the herbal composition safety and tolerability. The safety assessment of the CL25216 will also include routine laboratory investigations on blood, urine and clinical chemistry at Screening/Randomisation visit and the final visit of the intervention.

Conditions

• Vasomotor Symptoms

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	CL25216	250mg to take one capsule a day after breakfast for 105 days
DIETARY_SUPPLEMENT	Placebo	One capsule a day after breakfast for 105 days

Timeline

• Start date: 2025-11-24
• Primary completion: 2026-06-12
• Completion: 2026-06-12
• First posted: 2025-08-08
• Last updated: 2025-12-05

Locations

1 site across 1 country: India