Inositol Supplementation to Treat PCOS (INSUPP-PCOS)

Launched by MILTON S. HERSHEY MEDICAL CENTER · Mar 4, 2019

Keywords

ClinConnect Summary

The INSUPP-PCOS clinical trial is studying whether Inositol, a dietary supplement, can help improve symptoms related to Polycystic Ovary Syndrome (PCOS) in women. PCOS can cause issues like irregular menstrual cycles, high levels of male hormones, and problems with insulin and blood sugar. The goal of this study is to see if Inositol can help women with these symptoms, particularly those who have not been having regular menstrual periods or have certain ultrasound findings related to PCOS.

Women between the ages of 18 and 40 who have irregular menstrual cycles, high testosterone levels, and specific ultrasound results showing signs of PCOS may qualify to participate. However, women with certain medical conditions, like high levels of prolactin or thyroid issues, or those taking specific medications, will not be eligible. If you choose to participate, you'll receive the Inositol supplement or a placebo (a non-active substance) to compare results. This trial is currently recruiting participants, and being part of it could contribute to better understanding and treatment options for PCOS in the future.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women with chronic anovulation or oligomenorrhea defined as spontaneous intermenstrual periods of greater than or equal to 45 days or a total of less than or equal to 8 menses per year.
• • Women with Hyperandrogenism defined as a total testosterone greater than 50 ng/dL or a free androgen index greater than 10.
• • Women with Polycystic Ovaries on Ultrasound defined as either 12 or more follicles measuring 2-9 mm in diameter or increased ovarian volume greater than 10 cm.
• Exclusion Criteria:
• • Women with Hyperprolactinemia defined as 2 prolactin levels at least one week apart greater than 30 ng/mL.
• • Women with known 21-hydroxylase deficiency or other enzyme deficiency leading to the congenital adrenal hyperplasia.
• • Women with elevated FSH levels greater than 10 mIU/mL.
• • Women with uncorrected thyroid disease as per ASRM guidelines for nonpregnant subjects (TSH less than 0.45 mIU/mL or greater than 4.5 MIU/mL).
• • Women with a suspected adrenal or ovarian tumor secreting androgens
• • Women with Cushing's syndrome
• • Women on confounding medications which affect ovarian function including metformin, hormonal contraceptives or other medications for type 2 diabetes
• • Women with medical conditions that are contraindications to OTC inositol or previous allergic reactions to the supplement or to the placebo maltodextrin or inulin.