Exploring the Impact of Study drug on PCOS: Insights from Our Recent Phase III Clinical Study

Introduction

Polycystic Ovary Syndrome (PCOS) is a common endocrine disorder affecting women of reproductive age, characterized by irregular menstrual cycles, hyperandrogenism, and polycystic ovaries. Symptoms include weight gain, acne, hirsutism, and infertility, along with metabolic disturbances like insulin resistance and dyslipidemia

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Purpose of the Study

To evaluate the efficacy and safety of a Study drug in improving clinical and biological parameters in women with PCOS. The study aimed to determine if the Study drug could alleviate symptoms and enhance the overall quality of life by improving gut health and hormonal balance.

What we did?

Change in PCOSQ Score: The study measured the change in the Polycystic Ovary Syndrome Questionnaire (PCOSQ) score from baseline to Day 90 to assess the effectiveness of the Study drug in improving the quality of life for women with PCOS.

  • Change in PCOSQ score at intermediate time points.
  • Change in scores assessing physical symptoms like hair growth and acne.
  • Change in blood sugar levels and HbA1c.
  • Change in hormone levels, including FSH, LH, estradiol, and testosterone.
  • Change in lipid profile parameters, such as triglycerides, total cholesterol, LDL, and HDL.


Number of participants who experienced adverse events and those who discontinued the study drug

Conclusion

  • The primary outcome measure showed a significant improvement in the PCOSQ score from baseline to Day 90, indicating the effectiveness of the Study drug in enhancing the quality of life for women with PCOS.
  • Secondary outcome measures demonstrated improvements in various clinical and biological parameters, including hormonal balance, insulin sensitivity, and lipid profiles.
  • Safety endpoints were monitored, with a record of participants who experienced adverse events and those who discontinued the study drug.
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Potential Benefits of Probiotics in Managing PCOS

  • Improved Insulin Sensitivity: Probiotics may help enhance insulin sensitivity, a key factor in managing PCOS.

  • Reduced Inflammation: Probiotics can reduce systemic inflammation, which is often elevated in women with PCOS.

  • Hormonal Balance: By supporting gut health, probiotics might help balance hormones, including reducing excess androgen levels.

  • Weight Management: Certain probiotic strains may aid in weight loss and maintenance, beneficial for many women with PCOS.

  • Mood Regulation: Probiotics may improve mood and reduce anxiety, often associated with PCOS

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