Study of CL25216 Effects on Hot Flashes and Other Menopausal Symptoms in Women Aged 40 to 55

What this Trial Is About

Researchers are evaluating the effects of CL25216 on vasomotor symptoms in women during perimenopause. This study includes 80 healthy overweight women aged 40 to 55 years who have experienced changes in their menstrual cycle for at least three months. The purpose is to assess whether CL25216 can influence symptoms such as hot flashes and related quality of life measures during this transition phase in womens health. Participants will be randomly assigned to receive either 250 mg of CL25216 or a placebo, taken as one capsule daily after breakfast for 105 days. The study is designed as a double-blind, placebo-controlled trial with equal numbers in each group. Safety evaluations include monitoring vital signs and adverse events, along with routine laboratory tests of blood, urine, and clinical chemistry conducted at screeningrandomization and at the end of the treatment period. During the study, participants will undergo regular assessments using various tools like the Greene Climacteric Scale to measure vasomotor and psychological symptoms on days 1, 35, 70, and 105. Other evaluations include metabolic rate, mood, quality of life, sexual function, body weight, skin condition, and hormone levels. These comprehensive measures will help researchers understand the effects and safety of the study treatment over the intervention period.

Efficacy of CL25216 on Vasomotor Symptoms in Women During Perimenopause