Efficacy of CL25216 on Vasomotor Symptoms in Women During Perimenopause
ConditionVasomotor Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-55
SponsorApexCPG LLC
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy overweight women (BMI: 25-29 kg/m2) aged between 40 to 55 years with reports of changes in their menstrual cycle for at least 3 months.
Participants needed to have a total score of greater than 16 on the Greene Climacteric Scale (GCS), have an intact uterus and ovaries.
Early Perimenopausal Women according "The Stages of Reproductive Aging Workshop (STRAW) Classification (-2)" irregular periods without skipping menstrual cycles and more than seven days difference in length of consecutive cycles.
Subjects with serum FSH >20 U/L on 3-5 days of menstrual cycle.
Disqualifiers
History of cerebrovascular disease, thrombo-embolic disorders, heart attack, or angina at any time or thrombophlebitis within the last 5 years, on anti-coagulant or anti-platelet drugs daily for any conditions.
Subjects who had received hormonal treatment or any other herbal products in the previous 6 months.
Subjects underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded.
Subjects diagnosed with ovarian cysts ≥ 4 cm or any underlying pathology in pelvic ultrasonography (USG) performed during screening.
Trial design
Design model
Parallel
Treatments tested in this trial
CL25216
Dietary supplement250mg to take one capsule a day after breakfast for 105 days
Placebo
Dietary supplementOne capsule a day after breakfast for 105 days
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: CL25216Experimental treatment 1 intervention
Group B: PlaceboOther 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline to the end of the study period in: Scores of Greene Climacteric Scale (GCS)
The Greene Scale is a validated instrument designed to provide a concise assessment of menopause symptoms. It consists of 21 items, each measuring the severity of climacteric symptoms on a scale from 0 (none) to 3 (severe), where 1 indicates mild and 2 indicates moderate symptoms. The total score ranges from 0 to 63, with higher scores reflecting more severe climacteric symptoms.
Time frame
Day 1, 35, 70, and 105Secondary outcomes
1
Change from baseline to the end of the study period in: GCS sub-scale psychological symptoms
Psychological score is calculated from 1 to 11 items of GCS, ranges from 0 - 33, with higher scores reflecting more severe climacteric symptoms.
Time frame
Day 1, 35, 70, and 1052
Change from baseline to the end of the study period in: GCS sub-scale scores: somatic/ physical symptoms
Somatic/ physical symptoms score is calculated from 12 to 18 items of GCS, ranges from 0 - 21, with higher scores reflecting more severe climacteric symptoms.
Time frame
Day 1, 35, 70, and 1053
Change from baseline to the end of the study period in: GCS sub-scale scores: vasomotor symptoms.
Vasomotor symptoms score is calculated from 19 to 21 items of GCS, ranges from 0 - 9, with higher scores reflecting more severe climacteric symptoms.
Time frame
Day 1, 35, 70, and 1054
Change from baseline to the end of the study period in: Resting Metabolic Rate (RMR)
RMR reflects the caloric expenditure necessary for life, without accounting for physical activity or digestion, measured by using metabolic analyzer. Increase in RMR is a sign of improved metabolism
Time frame
Day 1, and 105Sponsors and contacts
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Source ClinicalTrials.gov