Health Condition 1: E282- Polycystic ovarian syndrome
Conditions
Interventions
Intervention1: Mirror PCOS Advanced Care Tablets: Subjects will receive Mirror-PCOS Advanced Care Tablets, 1 tablet orally once daily after breakfast for a total duration of 30 consecutive days.
Contr
Sponsors
Miror Therapeutics Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age and Sex: Female participants aged 18–35 years at the time of informed consent. 2. Diagnosis- Clinically diagnosed with Polycystic Ovary Syndrome (PCOS) based on Rotterdam 2003 criteria. 3. General Health: Subjects with stable general health, without any acute illness or uncontrolled chronic condition that could interfere with study outcomes. 4. Contraception: If sexually active, willing to use a reliable non-hormonal contraceptive method during the study and provide a negative urine pregnancy test at Baseline. 5. Compliance: Willing and able to comply with the study requirements, including completing all scheduled visits, laboratory assessments, and questionnaires. 6. Informed Consent: Capable of understanding the study requirements and providing written informed consent prior to participation.
Exclusion criteria
Exclusion criteria: 1. Pregnancy and Lactation: Pregnant or breastfeeding women. 2. Recent Surgery or Trauma: History of recent major surgery, hepatic failure, or significant trauma within the last 3 months. 3. Concurrent Illness: Presence of major systemic illnesses including: o Bronchial asthma, o Hematological disorders, o Malignancies, o Cardiovascular disease, o Carcinoma, o Severe renal or hepatic dysfunction. Protocol No.: CTSRS/2521 Confidential Page 16 of 35 Ver./Date: 1.0/01 Sep 2025 4. Medication Use: o Current or recent (within 3 months) use of hormonal contraceptives, anti-androgens, ovulation induction agents, or insulin-sensitizing drugs (e.g., metformin, pioglitazone). o Current participation in another interventional drug study or use of investigational products within the past 3 months. 5. Allergies: Known allergy or intolerance to any of the investigational product ingredients. 6. Other Endocrine Disorders: Presence of other causes of anovulation/hyperandrogenism such as: o Non-classical congenital adrenal hyperplasia, o Cushing’s syndrome, o Hyperprolactinemia, o Androgen-secreting neoplasms, o Thyroid dysfunction. 7. Substance Use: Current smokers, alcohol or substance abuse that could interfere with adherence to study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Metabolic-Mean change in fasting blood glucose (milligrams per deciliter) from Baseline visit to Day Thirty. Reproductive or Ovarian- Mean change in antral follicle count and ovarian volume (cubic centimeters) by pelvic ultrasound from Screening or Baseline to Day Thirty. Stress Axis Biomarker- Mean change in serum cortisol (micrograms per deciliter) from Screening or Baseline to Day Thirty.Timepoint: Screening (Day –7 to 0), Baseline (Day 0), Day 15 ±2 Days, Day 30 ±2 Days (EOS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Nutritional and Functional Status- Change in Subject Global Assessment score from Screening or Baseline to Day Thirty. Quality of Life- Change in World Health Organization Quality of Life BREF domain scores from Screening or Baseline to Day Thirty. Safety and Tolerability- Incidence, severity, seriousness, and relationship of adverse events and serious adverse events recorded across Thirty days. Proportion of subjects discontinuing due to adverse events. Clinically significant changes in laboratory safety parameters including fasting blood glucose, cortisol, and ultrasound findings.Timepoint: Screening (Day –7 to 0), Baseline (Day 0), Day 15 ±2 Days, Day 30 ±2 Days (EOS) | — |
Countries
India
Contacts
Public ContactMs Arpita Malgi
Samahitha Research Solutions
Outcome results
None listed