Actively Recruiting

Phase Not Applicable
Age: 40Years - 55Years
FEMALE
Healthy Volunteers
NCT07112651

Efficacy of CL25216 on Vasomotor Symptoms in Women During Perimenopause

Led by ApexCPG LLC · Updated on 2025-12-05

80

Participants Needed

1

Research Sites

28 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Efficacy of CL25216 on Vasomotor Symptoms in Women During Perimenopause

Who Can Participate

Age: 40Years - 55Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy overweight women aged 40 to 55 years with changes in menstrual cycle for at least 3 months
  • Total score greater than 16 on Greene Climacteric Scale
  • Early perimenopausal with irregular periods as per STRAW classification
  • Serum FSH greater than 20 U/L on days 3-5 of menstrual cycle
  • Normal pelvic ultrasound and breast mammogram
  • Normal fasting blood glucose less than 125 mg/dl
  • Understands study procedures and provides signed informed consent
  • Normal blood thyroid profile
  • Sexually active females of childbearing potential agree to use contraception and are not pregnant or lactating
  • Clinical screening including vital signs, ECG, and lab tests within reference ranges or not clinically significant
Not Eligible

You will not qualify if you...

  • History of cerebrovascular disease, thrombo-embolic disorders, heart attack, angina, or recent thrombophlebitis
  • Use of anticoagulant or antiplatelet drugs daily
  • Hormonal treatment or herbal product use in previous 6 months
  • COVID-19 treatment in last 3 months or positive test during study
  • Ovarian cysts 4 cm or larger or other pelvic pathology
  • Major life stressors, depression, or medications affecting steroid hormones
  • Active gall bladder disease or recent gynecological/breast surgery
  • History of breast, endometrial, gynecological, or other cancer within 5 years
  • Abnormal ECG
  • Pregnant or breastfeeding females
  • Hypersensitivity to investigational product or components
  • Blood donation or loss of 1 unit/350 mL within 90 days before first dose
  • Use of recreational drugs
  • Significant medical illness interfering with study
  • Participation in other clinical studies within 30 days
  • High blood pressure at screening (systolic ≥160 mmHg or diastolic ≥100 mmHg)
  • Progressive systemic diseases or autoimmune conditions
  • Significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, malignancies, or hypothyroidism
  • High alcohol intake (>2 drinks/day) or heavy smoking (>5 cigarettes/day)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shree Hospitals

Vijayawada, India

Actively Recruiting

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Research Team

M

Mr. T.V.N. Rao

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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