Clinical trial

Inositol Supplementation to Treat Polycystic Ovary Syndrome: A Double Blind Dose Ranging RCT (INSUPP-PCOS)

Name

Study00010252

Description

To determine if Inositol, a dietary supplement, will improve ovarian and adrenal androgen excess in women with Polycystic Ovarian Syndrome(PCOS).

Trial arms

Trial start

2020-01-24

Estimated PCD

2024-08-31

Trial end

2024-08-31

Status

Recruiting

Phase

Early phase I

Treatment

Placebo

Arms:

Placebo Treatment bid

Other names:

maltodextrin and inulin

Inositol

1gm/bid, 2gm/bid or 3gm/bid of Inositol powder

Arms:

Active Treatment with Inositol 1gm/bid, Active Treatment with Inositol 2 gm/bid, Active Treatment with Inositol 3 gm/bid

Size

128

Primary endpoint

Change in total testosterone

baseline and 3 months

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Placebo Group; Active Treatment with Inositol 1gm/bid; Active Treatment with Inositol 2gm/bid; Active Treatment with Inositol 3gm/ bid', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 128, 'type': 'ESTIMATED'}}

Updated at

2024-02-07

1 organization

1 product

6 indications

Organization

Milton S. Hershey Medical Center

Product

Inositol

Indication

Polycystic Ovary Syndrome

Indication