Clinical study on VAMHA and MYRHA Tablets in Polycystic ovary syndrome

Phase 2

Conditions: Health Condition 1: E282- Polycystic ovarian syndrome

Registration Number: CTRI/2022/12/048147

Lead Sponsor: Gynoveda Femtech Pvt. Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Female patients diagnosed with PCOS by presence of two of the of the three Rotterdam criteria: Oligomenorrhoea, anovulation; Hyperandrogenism (high total testosterone levels); and the observation of polycystic ovaries by USG.

2. Subjects not immediately (at the time of screening) requiring Hormone therapy for the treatment of PCOS

3. Subjects who were willing to follow the procedures as per the study protocol and voluntarily signing informed consent form.

Exclusion Criteria

1. Subjects with excessive menstrual bleeding

2. Subjects having organic causes of menstrual abnormalities like uterine myeloma, pelvic inflammatory disease adenomyosis, polyps, fibroids, endometriosis, cervical erosion (as diagnosed by USG lower abdomen and pelvis).

3. Subjects having clinical and/or biochemical signs of severe hyperandrogenism

4. Subjects having systematic illness like uncontrolled hypertension, uncontrolled diabetes mellitus, renal disease, tuberculosis, liver disorder, coagulation disorder, Hirsutism, Addisonâ??s disease and/or Cushing disease.

5. Subjects with uncontrolled Hyper or Hypothyroidism

6. Subjects with raised Prolactin levels

7. Subjects with one year of history of child birth

8. History of genitor-urinary surgery, and/or other major medical or surgical diseases; which can affect or related with study outcomes.

9. Use of corticosteroids or hormones or hormonal drugs within last 1 months of screening visit.

10. Use of any other investigational drug within 1 month prior to screening visit.

11. Subjects having known hypersensitivity to any ingredient of the study drug.

12. Any other condition which in the opinion of investigator would have placed the subject at risk or would have influenced the conduct of study or interpretation of results

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of subjects achieving regular menstruation and adequate menstrual flow and duration (frequency, duration, and quantity)Timepoint: Screening visit (up to day 7), Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180

Secondary Outcome Measures

Name	Time	Method
1.Number of subjects achieving ovulation (Urine Ovulation test) <br/ ><br>2.Change in symptoms associated with irregular menstruation <br/ ><br>3.Change in polycystic ovary as observed in the USG <br/ ><br>4.Change in AMH level <br/ ><br>5.Change in total sr. testosterone levels <br/ ><br>6.Requirement of hormone therapy <br/ ><br>7.Change in metabolic profile (HbA1c and Serum insulin). <br/ ><br>8.Change in body Weight, BMI, Waist circumference, Hip Circumference, Waist Hip Ratio <br/ ><br>9.Change in skin health condition (acne, pigmentation, glow etc) <br/ ><br>10.Global assessment for overall change by subjects and investigator <br/ ><br>11.Post-treatment assessment of tolerability of study drugs <br/ ><br>12.Changes in laboratory parameters <br/ ><br>Timepoint: Screening visit (up to day 7), Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180