Understanding the pathophysiology of vasomotor symptoms (hot flushes and night sweats) that occur in perimenopause, menopause, and postmenopause life stages.
D C Deecher, K Dorries
https://pubmed.ncbi.nlm.nih.gov/18074100Actively Recruiting
Phase Not Applicable
Age: 40Years - 55Years
FEMALE
Healthy Volunteers
ID07112651
The Effects of CL25216 on Vasomotor Symptoms in Women During Perimenopause: A Randomised, Double-blind, Placebo-controlled Study
Led by ApexCPG LLC · Updated on 2025-12-05
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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 women's 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 screening/randomization 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.
CONDITIONS
Brief Title
Efficacy of CL25216 on Vasomotor Symptoms in Women During Perimenopause
Who Can Participate
Age: 40Years - 55Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Healthy overweight women with BMI between 25 and 29 kg/m2 aged 40 to 55 years
- Reports of menstrual cycle changes for at least 3 months
- Total score greater than 16 on Greene Climacteric Scale
- Intact uterus and ovaries
- Early perimenopausal status with irregular periods as per STRAW classification
- Serum FSH level greater than 20 U/L on days 3-5 of menstrual cycle
- Normal pelvic ultrasound and breast mammogram
- Normal fasting blood glucose below 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 with vital signs, ECG, and labs within normal range or clinically acceptable
You will not qualify if you...
- History of cerebrovascular disease, thrombo-embolic disorders, heart attack, angina, or thrombophlebitis within last 5 years
- Daily use of anticoagulant or antiplatelet drugs
- Hormonal or herbal treatments within previous 6 months
- COVID-19 treatment within last 3 months or positive test during study
- Ovarian cysts 4 cm or larger or other pelvic pathology on ultrasound
- Major life stressors, depression, or medications impacting steroid hormones
- Active gall bladder disease or recent gynecological or breast surgery
- History of breast, endometrial, or other gynecological cancers, or cancer within last 5 years
- Abnormal ECG
- Pregnant or breastfeeding
- Hypersensitivity to study product or components
- Recent blood donation or loss within 90 days
- Use of recreational drugs
- Clinically significant illnesses interfering with study
- Participation in another investigational drug study within 30 days
- High blood pressure at screening (≥160/100 mmHg)
- Progressive systemic or autoimmune diseases
- Significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies
- 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
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 105 days
Participants take one capsule a day after breakfast for 105 days, either CL25216 250 mg or placebo, to evaluate effects on vasomotor symptoms during perimenopause.
Visits on Day 1, 35, 70, and 105 for assessments
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
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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Efficacy and safety of a special extract of Rheum rhaponticum (ERr 731) in perimenopausal women with climacteric complaints: a 12-week randomized, double-blind, placebo-controlled trial.
Marianne Heger, Boris M Ventskovskiy, Irina Borzenko...
https://pubmed.ncbi.nlm.nih.gov/16894335Hormone changes associated with the menopausal transition.
H I Su, E W Freeman
https://pubmed.ncbi.nlm.nih.gov/19942836The Menopause Transition: Signs, Symptoms, and Management Options.
Nanette Santoro, Cassandra Roeca, Brandilyn A Peters...
https://pubmed.ncbi.nlm.nih.gov/33095879Perimenopause: From Research to Practice.
Nanette Santoro
https://pubmed.ncbi.nlm.nih.gov/26653408