Treatment of Women With Hyperandrogenic PCOS With Two Different Ratios of Myo-inositol:D-chiro-inositol: A Comparison

Lo.Li.Pharma

Status: Completed

Conditions: Polycystic Ovarian Syndrome (PCOS)

Treatments: Dietary Supplement: Myo-Inositol and D-Chiro-Inositol (40:1); Dietary Supplement: Myo-Inositol and D-Chiro-Inositol (3.6:1)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06715527

Ino-ratio_2024

Details and patient eligibility

About

In this study, female patients diagnosed with polycystic ovary syndrome (PCOS) will be enrolled. In particular, those with elevated testosterone or with clinical signs of hyperandrogenism, along with menstrual cycle alterations and/or polycystic ovary morphology at ultrasound, will be included in the study.

Current treatments for PCOS include insulin sensitizers (such as metformin) and hormonal contraceptives. However, they are not devoid of side effects or may not be well tolerated, often leading to therapy discontinuation. Inositol represents a valid alternative to standard treatments, as it serves both as insulin sensitizer and as second messenger of FSH in the ovaries, thus regulating glucose metabolism and supporting ovarian function. The presence of two inositol isomers, namely myo-inositol and D-chiro-inositol, in defined ratios in human tissues suggests that supplementation with both would be ideal. Despite numerous evidence available, the ratio that gives the best clinical results is still debated.

In the present clinical trial, patients will be given a dietary supplement containing myo-inositol and D-chiro-inositol in two ratios (either 40:1 or 3.6:1, respectively) for three months. Restoration of regular menstrual cycle and of hormonal status will be the primary goal of the intervention.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• PCOS according to the Rotterdam Criteria
• Clinical or biochemical hyperandrogenism

Exclusion criteria

• other causes of ovulatory disfunction (e.g., hyperprolactinemia or hypothyroidism)
• other causes of hyperandrogenism (e.g., adrenal hyperplasia or Cushing's syndrome)
• use of medications that influence ovulation
• hormonal treatments
• chronic pharmacological therapies
• use of inositol-containing supplements
• regular consumption of inositol-enriched food

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Treatment

Experimental group

Description:

Women with PCOS under oral supplementation with myo-inositol and D-chiro-inositol in 40:1 ratio

Treatment:

Dietary Supplement: Myo-Inositol and D-Chiro-Inositol (40:1)

Comparator

Active Comparator group

Description:

Women with PCOS under oral supplementation with myo-inositol and D-chiro-inositol in 3.6:1 ratio

Treatment:

Dietary Supplement: Myo-Inositol and D-Chiro-Inositol (3.6:1)