Efficacy of CL25216 on Hormonal Balance and Menstrual Health in Women With Primary Dysmenorrhea.

NCT07529561 | Not Yet Recruiting

• 2 other identifiers: APX/PD/CL25216/25CTRI/2026/04/107776
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the effects of CL25216 on hormonal balance and menstrual health in women with primary dysmenorrhea. Enrolled subjects will receive either CL25216 - 250 mg/day or placebo.

Conditions

Primary Dysmenorrhea; Menstural Cramps

Outcome Measures

Primary Outcomes (1)

• Menstrual symptom Questionnaire

  The MSQ is a validated instrument designed to provide a concise assessment of menstrual pain symptoms. It consists of 25 items, each measuring the severity of climacteric symptoms on a scale from 1 (never) to 5 (always), in between 2 emans rarely, 3 means sometimes and 4 represents. The total score ranges from 29 to 125, with higher scores reflecting more severe menstrual pain symptoms.

  At day 1, 28, 56, and 84

Secondary Outcomes (22)

• Pain duration

  At day 1, 28, 56, and 84

• Female sexual function index

  At day 1, 28, 56, and 84

• Resting Metabolic Rate (RMR)

  At day 1, 28, 56, and 84

• Bodyweight

  At day 1, 28, 56, and 84

• BMI

  At day 1, 28, 56, and 84

Study Arms (2)

CL25216

EXPERIMENTAL

CL25216: 250mg, One capsule a day after breakfast for 84 days.

Dietary Supplement: CL25216

Placebo

OTHER

One capsule a day after breakfast for 84 days.

Other: Placebo

Interventions

CL25216 DIETARY_SUPPLEMENT

CL25216: 250mg, One capsule a day after breakfast for 84 days.

CL25216

Placebo OTHER

One capsule a day after breakfast for 84 days.

Placebo

Eligibility Criteria

• Age: 25 Years - 40 Years
• Gender Eligibility Details: Healthy females aged between 25-40 years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy females aged between 25-40 years with a Body Mass Index (BMI) of approximately 25 to 29 kg/m2.
• Healthy women with primary dysmenorrhea Grade 2 (measured using Verbal Multi-dimensional scoring system (VMSS)) at least for 1 day in 50 % of menstrual cycles and maximum pain intensity score ≥4 on a 10 cm VAS for at least 3 menstrual cycles before participating in the study.
• Subjects with regular menstrual cycles that typically occur between every 21-35 days (menstrual period 3-7 days) in last 6 months.
• Subjects with normal pelvic TVS and breast mammogram.
• Subjects without any chronic diseases having symptoms such as burning, itching, abnormal vaginal discharge.
• Subjects willing to provide their age of menarche and regularity in menstrual cycle.
• Subjects without any clinical history of Gynaecological disorders or ovarian pathology, pelvic pathology like pelvic inflammatory disease, tumour and fibroma or without any history of pelvic surgery (screened using pelvic transvaginal sonography (TVS))
• Subjects with normal thyroid profile
• Subjects willing not to use any analgesics 24 hrs. prior screening and throughout the study.
• Females of childbearing potential who are sexually active must agree to use adequate non-hormonal contraception during the study.
• Subject understands the study procedures and provides signed informed consent to participate in the study

You may not qualify if:

• Subjects with irregular menstrual cycle (shorter than 21 and longer than 35 days) affecting the treatment and efficacy judgment.
• Subjects with secondary dysmenorrhea (menstrual pain associated with conditions such as endometriosis, pelvic inflammatory disease, leiomyomas, Mullerian anomalies, and adenomyosis and interstitial cystitis).
• Subjects who are on related medications such as NSAIDs or hormonal contraceptive pills or intrauterine contraceptive devices in the past 3 months.
• 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 with a high blood pressure (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg) and Fasting blood glucose level \>125 mg/dl at screening.
• Subjects who had any hormonal therapy or any other herbal products in the past 3 months.
• Hypothyroidism, hyperthyroidism, hyperprolactinemia, Cushing's syndrome and congenital adrenal hyperplasia, following a special diet for the past 3 months, taking drugs affecting insulin sensitivity or lipid and hormonal profiles, including glucocorticoids, ovulation-stimulating drugs, anti-obesity, anti-diabetes, anti-hypertensive, anti-estrogenic, anti-androgenic during the last 3 months.
• Active gall bladder disease, gynaecological or breast surgery in the last 6 months.
• Subjects underwent hysterectomy or bilateral oophorectomy.
• History of breast, endometrial, other gynaecological cancer at any time or other cancer within the last 5 years.
• Smokers or tobacco users.
• Alcohol intake (\>2 standard drinks per day), or recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) or psychiatric drug users.
• Pregnant and lactating mothers.
• History of hypersensitivity reactions attributed to investigational product (IP) or its components or related products.
• History of positive hepatitis screening including Hepatitis B surface antigen or Hepatitis C virus (HCV) antibodies or subjects with human immunodeficiency virus (HIV) and /or syphilis.

Sponsors & Collaborators

• ApexCPG LLC: lead

Study Sites (1)

DEC Healthcare Hospital,

Nellore, Andhra Pradesh, India

Location

Related Publications (5)

• Ferries-Rowe E, Corey E, Archer JS. Primary Dysmenorrhea: Diagnosis and Therapy. Obstet Gynecol. 2020 Nov;136(5):1047-1058. doi: 10.1097/AOG.0000000000004096.

  PMID: 33030880 BACKGROUND

• Proctor M, Farquhar C. Diagnosis and management of dysmenorrhoea. BMJ. 2006 May 13;332(7550):1134-8. doi: 10.1136/bmj.332.7550.1134. No abstract available.

  PMID: 16690671 BACKGROUND

• Gebeyehu MB, Mekuria AB, Tefera YG, Andarge DA, Debay YB, Bejiga GS, Gebresillassie BM. Prevalence, Impact, and Management Practice of Dysmenorrhea among University of Gondar Students, Northwestern Ethiopia: A Cross-Sectional Study. Int J Reprod Med. 2017;2017:3208276. doi: 10.1155/2017/3208276. Epub 2017 May 14.

  PMID: 28589173 BACKGROUND

• Chuamoor K, Kaewmanee K, Tanmahasamut P. Dysmenorrhea among Siriraj nurses; prevalence, quality of life, and knowledge of management. J Med Assoc Thai. 2012 Aug;95(8):983-91.

  PMID: 23061300 BACKGROUND

• Chen CX, Shieh C, Draucker CB, Carpenter JS. Reasons women do not seek health care for dysmenorrhea. J Clin Nurs. 2018 Jan;27(1-2):e301-e308. doi: 10.1111/jocn.13946. Epub 2017 Sep 7.

  PMID: 28681499 BACKGROUND

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: April 8, 2026
• First Posted: April 14, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): September 10, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)