Efficacy of CL25216 on Vasomotor Symptoms in Women During Perimenopause

NCT07112651 | Recruiting

• 1 other identifier: APX/VMS/CL25216/25
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Vasomotor Symptoms

Outcome Measures

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.

  Day 1, 35, 70, and 105

Secondary Outcomes (19)

• Change from baseline to the end of the study period in: GCS sub-scale psychological symptoms

  Day 1, 35, 70, and 105

• Change from baseline to the end of the study period in: GCS sub-scale scores: somatic/ physical symptoms

  Day 1, 35, 70, and 105

• Change from baseline to the end of the study period in: GCS sub-scale scores: vasomotor symptoms.

  Day 1, 35, 70, and 105

• Change from baseline to the end of the study period in: Resting Metabolic Rate (RMR)

  Day 1, and 105

• Change from baseline to the end of the study period in: Positive and Negative Affect Schedule (PANAS-X)

  Day 1, 35, 70, and 105

Study Arms (2)

CL25216

EXPERIMENTAL

250 mg to take one capsule a day after breakfast for 105 days

Dietary Supplement: CL25216

Placebo

OTHER

One capsule a day after breakfast for 105 days

Dietary Supplement: Placebo

Interventions

CL25216 DIETARY_SUPPLEMENT

250mg to take one capsule a day after breakfast for 105 days

CL25216

Placebo DIETARY_SUPPLEMENT

One capsule a day after breakfast for 105 days

Placebo

Eligibility Criteria

• Age: 40 Years - 55 Years
• Gender Eligibility Details: Healthy overweight women aged between 40 to 55 years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ApexCPG LLC: lead

Study Sites (1)

Shree Hospitals

Vijayawada, India

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• Su HI, Freeman EW. Hormone changes associated with the menopausal transition. Minerva Ginecol. 2009 Dec;61(6):483-9.

  PMID: 19942836 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Central Study Contacts

Mr. T.V.N. Rao

CONTACT

+91 8331015069; tvnrao.apex@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2025
• First Posted: August 8, 2025
• Study Start: November 24, 2025
• Primary Completion (Estimated): June 12, 2026
• Study Completion (Estimated): June 12, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)