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Can a simple supplement tame PCOS hormones?

NCT ID NCT03864068

Disease control Sponsor: Milton S. Hershey Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether inositol, a natural dietary supplement, can lower high testosterone levels in women with polycystic ovary syndrome (PCOS). 154 women took either a placebo or one of three doses of inositol powder for a set period. Researchers measured changes in testosterone, insulin, and glucose tolerance to see if the supplement helps control the condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Inositol (a dietary supplement)
What this could lead to
If it works, this could point toward a simple, over-the-counter supplement to help manage hormone imbalances in women with PCOS.
What could go wrong
This is a small, early-phase trial with only 154 participants. The supplement may not significantly improve symptoms, and results may not apply to all women with PCOS.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

154 people

The number who actually took part.

Started

Jan 2020

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

anovulation glucose intolerance Hyperandrogenism Insulin Resistance metabolic disease polycystic ovary syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anovulation Glucose intolerance Hyperandrogenism Insulin resistance Metabolic complication Polycystic ovary syndrome

Contacts and locations

Locations

  • Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

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