Primary DysmenorrheaPDNCT07529561
Efficacy of CL25216 on Hormonal Balance and Menstrual Health in Women With Primary Dysmenorrhea.
A study testing CL25216 in people with Primary Dysmenorrhea and Menstural Cramps, run by ApexCPG LLC at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea, Menstural Cramps
- What is being tested?
- CL25216
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- 13 Apr 2026to 10 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
- Normal vital signs, including 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.
- Subject understands the study procedures and provides signed informed consent to participate in the study
Who cannot join
- 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.
Show all 19Show fewer
- 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.
- History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
- Any condition that in opinion of the Investigator, does not justify the subjects' participation in the study.
- Subjects with a systemic disease including tuberculosis, leucosis, collagenosis, multiple sclerosis or other autoimmune diseases.
- Subject consumes significant amounts of soya products in the diet or any products containing red clover, black cohosh, omega 3 or omega 6 fatty acids or any other Ayush or homeopathic preparations that can interfere with the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
DEC Healthcare Hospital,
Nellore, Andhra Pradesh
Dr. S Sailaja, MS, 0861-2320232
About this study
Official title: The Effect of CL25216 on Hormonal Balance and Menstrual Health in Women With Primary Dysmenorrhea: A Randomized, Double-blind, Placebo Controlled Clinical Trial
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.
Read the detailed description
The purpose of this study is to evaluate the effect of CL25216 on hormonal balance and menstrual health in women with primary dysmenorrhea. A total of 80 female aged between 25-40 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 1:1 ratio. The subjects will be instructed to take one capsule a day after breakfast for 84 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 visit and the final visit of the intervention.
- Conditions
- Primary Dysmenorrhea, Menstural Cramps
- Being tested
- CL25216, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CL25216Dietary supplement
CL25216: 250mg, One capsule a day after breakfast for 84 days.
PlaceboOther
One capsule a day after breakfast for 84 days.
| Study group | Role | What they receive |
|---|---|---|
| CL25216 | Experimental | CL25216: 250mg, One capsule a day after breakfast for 84 days. Receives: Dietary Supplement: CL25216 |
| Placebo | Other | One capsule a day after breakfast for 84 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At day 1, 28, 56, and 84
Secondary outcomes (22)
Pain duration
No. of days subject experiencing the pain during menstrual cycle will be captured. As the no. of days increasing, QoL decreases.
Measured: At day 1, 28, 56, and 84
Female sexual function index
The FSFI was developed as a brief, easy-to-administer, self-report tool for assessing key dimensions or domains of sexual function and quality of life in various populations of women. Female Sexual Function Index (FSFI), a widely used tool with six domains (Arousal, Desire, Orgasm, Lubrication, Satisfaction, and Pain). The total FSFI score ranges from minimum score of 2 and maximum score of 36. Greater Scores indicates better sexual function
Measured: At day 1, 28, 56, and 84
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
Measured: At day 1, 28, 56, and 84
Bodyweight
The subject's body weight is measured using a digital weighing scale. An improvement is indicated when the body weight falls within the normal range based on the subject's demographic characteristics.
Measured: At day 1, 28, 56, and 84
BMI
Body mass index is a calculated measure by considering the weight and height of a subject. A change in BMI from overweight to normal range is a positive indicator of healthy lifestyle.
Measured: At day 1, 28, 56, and 84
Waist Circumference
Waist circumference is measured around the abdomen, just above the navel. This value is influenced by the subject's height and weight. A reduction in waist circumference indicates improvement in body weight, as well as decreased fat storage and deposition
Measured: At day 1, 28, 56, and 84
Hip Circumference
It represents the maximum circumference measured around the buttocks. This measurement is influenced by the subject's height and weight. A reduction in this value indicates improvements in body weight, as well as a decrease in fat storage and deposition
Measured: At day 1, 28, 56, and 84
Quality of life questionnaire (Short Form -36)
The 36-Item Short Form (SF-36) is a self-reported questionnaire used to assess overall health and quality of life. It consists of 8 domains, each scored on a scale from 0 to 100. Higher scores indicate a better quality of life and improved health status.
Measured: At day 1, 28, 56, and 84
Subjective self-assessments on hair quality
This is a subjective measurement of hair quality by considering the hair fall rate. The Highest Possible Score is 5.
Measured: At day 1, 28, 56, and 84
Skin wrinkle assessment
Visual assessment of skin wrinkles used to evaluate the appearance of skin aging and to determine the severity of wrinkles. This kind of assessment is typically done by a healthcare professional or dermatologist and involves examining the skin surface to identify and score wrinkles. Grade ranging from 0 to 9 where 0 represents no wrinkles and 9 represents deep wrinkles.
Measured: At day 1, 28, 56, and 84
Subject's self-assessment of skin Questionnaire
As the perception of the skin radiance is subjective, a self-assessment has been performed through a questionnaire. The scores range from 0 to 10, with higher scores indicating better skin quality in terms of complexion, smoothness, texture, elasticity, and hydration
Measured: At day 1, 28, 56, and 84
HOMA-IR
HOMA-IR is a simple and widely used method to estimate insulin resistance (IR) in perimenopause/menopause. HOMA-IR can be useful in assessing cardio metabolic risk
Measured: At day 1, 28, 56, and 84
Free testosterone
Testosterone in females is produced by the ovaries, adrenal gland, and peripheral conversion of precursors like DHEA/androstenedione in fat/skin cells. Decrease in testosterone level results in increased pain severity.
Measured: At day 1, 28, 56, and 84
Total testosterone
Testosterone in females is produced by the ovaries, adrenal gland, and peripheral conversion of precursors like DHEA/androstenedione in fat/skin cells. Decrease in testosterone level results in increased pain severity.
Measured: At day 1, 28, 56, and 84
Estradiol
Estradiol is the most potent and biologically active form of estrogen in humans produced majorly by ovaries, followed by adrenal. Fluctuations in this hormone impacts menstrual pain.
Measured: At day 1, 28, 56, and 84
LH
It is a hormone made by the pituitary gland that plays a key role in the reproductive system of females. Changes in LH levels cause ovulatory changes.
Measured: At day 1, 28, 56, and 84
FSH
It is a hormone produced by the pituitary gland and plays a crucial role in the reproductive systems of females. Changes in FSH results in disturbed menstrual health.
Measured: At day 1, 28, 56, and 84
LH:FSH
This marker is to evaluate the diagnosis of ovarian dysfunction. Increase in this value reflects the follicular arrest and anovulation.
Measured: At day 1, 28, 56, and 84
Anti-Mullerian hormone
AMH (Anti-Müllerian Hormone) is a marker of ovarian reserve, reflecting the number of remaining follicles in the ovaries. AMH testing could help to assess the menstrual quality of life.
Measured: At day 1, 28, 56, and 84
TNF-alpha
Tumor necrosis factor-alpha (TNF-alpha) is a potent, pro-inflammatory cytokine primarily produced by macrophages and monocytes, acting as a critical mediator of systemic inflammation. Increase in this concentration causes strong uterine contractions and pain.
Measured: At day 1, 28, 56, and 84
IL-6
Interleukin-6 (IL-6) is a key pro-inflammatory cytokine significantly elevated in the plasma and menstrual blood of women with primary dysmenorrhea. Increase in this concentration promotes uterine contractions and causes pain.
Measured: At day 1, 28, 56, and 84
GLP-1
Glucagon-like peptide-1 (GLP-1) is a crucial metabolic hormone released from intestinal L-cells upon food intake that regulates blood sugar and appetite. Increasing in GLP-1 aids in weight management and metabolism.
Measured: At day 1, 28, 56, and 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start13 Apr 2026 (estimated)
- Primary completion10 Sep 2026 (estimated)
- Study completion10 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ApexCPG LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529561
- Sponsor's protocol ID
- APX/PD/CL25216/25
- Other IDs
- CTRI/2026/04/107776
- Acronym
- PD
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33030880Proctor 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.
PubMed 16690671Gebeyehu 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.
PubMed 28589173Chuamoor 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.
PubMed 23061300Chen 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.
PubMed 28681499
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of CL25216 on Hormonal Balance and Menstrual Health in Women With Primary Dysmenorrhea: A Randomized, Double-blind, Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07529561
- Acronym / sponsor ID
- PD / APX/PD/CL25216/25
- Conditions
- Primary Dysmenorrhea, Menstural Cramps
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- ApexCPG LLCIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2026 (estimated)
- Primary completion
- 10 Sep 2026 (estimated)
- Study completion
- 10 Sep 2026 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to evaluate the effect of CL25216 on hormonal balance and menstrual health in women with primary dysmenorrhea. A total of 80 female aged between 25-40 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 1:1 ratio. The subjects will be instructed to take one capsule a day after breakfast for 84 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 visit and the final visit of the intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CL25216 | Experimental | Dietary Supplement: CL25216CL25216: 250mg, One capsule a day after breakfast for 84 days. |
| Placebo | Other | Other: PlaceboOne capsule a day after breakfast for 84 days. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CL25216CL25216: 250mg, One capsule a day after breakfast for 84 days. | Dietary supplement | CL25216 |
| PlaceboOne capsule a day after breakfast for 84 days. | Other | Placebo |
Primary outcome
Menstrual symptom Questionnaire
Time frame: At day 1, 28, 56, and 84
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.
22 secondary outcomes
Pain duration
Time frame: At day 1, 28, 56, and 84
Female sexual function index
Time frame: At day 1, 28, 56, and 84
Resting Metabolic Rate (RMR)
Time frame: At day 1, 28, 56, and 84
Bodyweight
Time frame: At day 1, 28, 56, and 84
BMI
Time frame: At day 1, 28, 56, and 84
Waist Circumference
Time frame: At day 1, 28, 56, and 84
Hip Circumference
Time frame: At day 1, 28, 56, and 84
Quality of life questionnaire (Short Form -36)
Time frame: At day 1, 28, 56, and 84
Subjective self-assessments on hair quality
Time frame: At day 1, 28, 56, and 84
Skin wrinkle assessment
Time frame: At day 1, 28, 56, and 84
Subject's self-assessment of skin Questionnaire
Time frame: At day 1, 28, 56, and 84
HOMA-IR
Time frame: At day 1, 28, 56, and 84
Free testosterone
Time frame: At day 1, 28, 56, and 84
Total testosterone
Time frame: At day 1, 28, 56, and 84
Estradiol
Time frame: At day 1, 28, 56, and 84
LH
Time frame: At day 1, 28, 56, and 84
FSH
Time frame: At day 1, 28, 56, and 84
LH:FSH
Time frame: At day 1, 28, 56, and 84
Anti-Mullerian hormone
Time frame: At day 1, 28, 56, and 84
TNF-alpha
Time frame: At day 1, 28, 56, and 84
IL-6
Time frame: At day 1, 28, 56, and 84
GLP-1
Time frame: At day 1, 28, 56, and 84
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Background: PubMed 33030880Ferries-Rowe E, Corey E, Archer JS. Primary Dysmenorrhea: Diagnosis and Therapy. Obstet Gynecol. 2020 Nov;136(5):1047-1058. doi: 10.1097/AOG.0000000000004096.
- Background: PubMed 16690671Proctor 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.
- Background: PubMed 28589173Gebeyehu 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.
- Background: PubMed 23061300Chuamoor 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.
- Background: PubMed 28681499Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CL25216 in people with Primary Dysmenorrhea and Menstural Cramps, run by ApexCPG LLC at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menstrual symptom Questionnaire (time frame: At day 1, 28, 56, and 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07529561, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.