Efficacy of CL25216 on Vasomotor Symptoms in Women During Perimenopause

Official title

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

Overview

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.

Interventions

• 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

Primary outcome measures

• Change from baseline to the end of the study period in: Scores of Greene Climacteric Scale (GCS) [Time frame: Day 1, 35, 70, and 105]

Secondary outcome measures (12)

• Change from baseline to the end of the study period in: GCS sub-scale psychological symptoms [Time frame: Day 1, 35, 70, and 105]
• Change from baseline to the end of the study period in: GCS sub-scale scores: somatic/ physical symptoms [Time frame: Day 1, 35, 70, and 105]
• Change from baseline to the end of the study period in: GCS sub-scale scores: vasomotor symptoms. [Time frame: Day 1, 35, 70, and 105]
• Change from baseline to the end of the study period in: Resting Metabolic Rate (RMR) [Time frame: Day 1, and 105]
• Change from baseline to the end of the study period in: Positive and Negative Affect Schedule (PANAS-X) [Time frame: Day 1, 35, 70, and 105]
• Change from baseline to the end of the study period in: Quality of life questionnaire (Short Form -36) [Time frame: Day 1, 35, 70, and 105]
• Change from baseline to the end of the study period in: Sexual Function - Female Sexual Function Index (FSFI) [Time frame: Day 1, 35, 70, and 105]
• Change from baseline to the end of the study period in: The Hot Flush Weekly Weighted Score (HFWWS) [Time frame: Day 1, 35, 70, and 105]
• Change from baseline to the end of the study period in: Bodyweight [Time frame: Day 1, 35, 70, and 105]
• Change from baseline to the end of the study period in: BMI [Time frame: Day 1, 35, 70, and 105]
• Change from baseline to the end of the study period in: Scores of subjective self-assessments on hair quality [Time frame: Day 1, 35, 70, and 105]
• Change from baseline to the end of the study period in: Skin wrinkle assessment [Time frame: Day 1, 35, 70, and 105]

Eligibility criteria

Inclusion criteria

• 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.
• Subjects with normal pelvic TVS and breast mammogram.
• Subjects with normal fasting blood glucose level (<125 mg/dl).
• Subject understands the study procedures and provides signed informed consent to participate in the study.
• Subjects with normal blood thyroid profile.
• Females of childbearing potential who are sexually active must agree to use adequate contraception and can neither be pregnant nor lactating from screening throughout the duration of the study.
• Clinical screening including vital signs, electrocardiogram (ECG) and laboratory evaluations (including clinical chemistry, haematology, and complete urinalysis) within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator.

Exclusion criteria

• 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.
• Chronic or acute life stressors relating to a major life change, experiencing depression and/or receiving medication for such illness or disorders, receiving statins or other drugs known to impact on steroid hormone levels.
• Subjects having active gall bladder disease, gynaecological or breast surgery in the last 6 months.
• History of breast, endometrial, other gynaecological cancer at any time or other cancer within the last 5 years.
• Subjects with abnormal ECG.
• Pregnant and breast feeding female.
• History of hypersensitivity reactions attributed to investigational product (IP) or its components or related products.
• Donation/loss of blood 1 unit or 350 mL within 90 days prior to receiving the first dose of study medication.
• Use of any recreational drugs (cocaine, amphetamine, barbiturates, benzodiazepines, cannabinoids, and morphine).
• History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol.
• Participated in a clinical study with an investigational drug or biologic within the last 30 days.
• Any condition that in opinion of the investigator, does not justify the subjects" participation in the study.
• Subjects with a high blood pressure at screening (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥ 100 mmHg).
• Subjects with progressive systemic diseases (e.g. tuberculosis, leucosis, collagenosis, multiple sclerosis, AIDS, HIV infections, Hepatitis B surface antigen or Hepatitis C virus (HCV) antibodies or other auto-immune diseases).
• Evidence or history of clinically significant (in the judgment of the Investigator) haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies, hypothyroidism.
• High alcohol intake (>2 standard drinks per day), smokers (>5 cigarettes per day).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Health services research

Study locations

India · 1 center

• Shree Hospitals — Vijayawada

Publications

• Deecher DC, Dorries K. Understanding the pathophysiology of vasomotor symptoms (hot flushes and night sweats) that occur in perimenopause, menopause, and postmenopause life stages. Arch Womens Ment Health. 2007;10(6):247-57. doi: 10.1007/s00737-007-0209-5. Epub 2007 Dec 12. PMID 18074100
• Heger M, Ventskovskiy BM, Borzenko I, Kneis KC, Rettenberger R, Kaszkin-Bettag M, Heger PW. 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. Menopause. 2006 Sep-Oct;13(5):744-59. doi: 10.1097/01.gme.0000240632.08182.e4. PMID 16894335
• Su HI, Freeman EW. Hormone changes associated with the menopausal transition. Minerva Ginecol. 2009 Dec;61(6):483-9. PMID 19942836
• Santoro N, Roeca C, Peters BA, Neal-Perry G. The Menopause Transition: Signs, Symptoms, and Management Options. J Clin Endocrinol Metab. 2021 Jan 1;106(1):1-15. doi: 10.1210/clinem/dgaa764. PMID 33095879
• Santoro N. Perimenopause: From Research to Practice. J Womens Health (Larchmt). 2016 Apr;25(4):332-9. doi: 10.1089/jwh.2015.5556. Epub 2015 Dec 10. PMID 26653408

Identifiers

NCT: NCT07112651 · APX/VMS/CL25216/25

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗