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Study on the Effects of Spironolactone, Pioglitazone, and Metformin for Adolescent Girls and Young Women with Polycystic Ovary Syndrome (PCOS)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as polycystic ovary syndrome (PCOS), which affects adolescent girls and young adult women. PCOS is a common hormonal disorder that can cause irregular menstrual cycles, excess hair growth, acne, and sometimes difficulty with fertility. The study is testing a treatment called SPIOMET, which is a combination of three medications: spironolactone, pioglitazone, and metformin. These medications are taken in tablet form and are designed to help manage the symptoms of PCOS by normalizing ovulation, which is the release of eggs from the ovaries.

The purpose of the study is to evaluate how effective and safe SPIOMET is for treating PCOS in young women. Participants in the study will be randomly assigned to receive either the SPIOMET tablets or a placebo. The study will last for a period of time during which participants will take the medication and attend regular check-ups to monitor their health and the effects of the treatment. The study aims to see if SPIOMET can help regulate menstrual cycles and improve other symptoms associated with PCOS.

Throughout the study, various health indicators will be monitored, including weight, height, and hormone levels. Participants will also be asked about their experiences with the medication, including any side effects they may encounter. The study will help determine if SPIOMET is a viable treatment option for young women with PCOS, potentially offering a new way to manage this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on age, gynaecological age, and symptoms related to polycystic ovary syndrome (PCOS).

    Informed consent is obtained from the participant or their legal representative if the participant is a minor.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to record baseline clinical and biochemical data. This includes measurements of weight, height, and blood pressure, as well as blood tests to evaluate hormone levels and other health indicators.

  3. Step 3

    Medication administration

    Participants receive a fixed-dose combination of spironolactone, pioglitazone, and metformin (SPIOMET) in tablet form, taken orally.

    The dosage and frequency of administration are determined by the study protocol and are followed throughout the treatment period.

  4. Step 4

    Ongoing monitoring

    Regular follow-up visits are scheduled to monitor the participant's response to the medication. This includes checking ovulation rates, menstrual regularity, and any side effects.

    Additional assessments may include imaging studies and lifestyle evaluations.

  5. Step 5

    Completion of treatment

    The treatment phase concludes as per the study timeline, and a final assessment is conducted to evaluate the overall impact of the medication on ovulation and other health parameters.

  6. Step 6

    Post-treatment follow-up

    Participants may be asked to return for post-treatment evaluations to assess the long-term effects of the treatment on their health.

Who can join the trial?

5 criteria

  • Participants must be between the ages of 12.1 and 23.9 years old at the start of the study.
  • Participants should have a gynaecological age of 2 years or more. This means it has been at least 2 years since their first menstrual period.
  • Participants must show signs of androgen excess. This can be seen through physical signs like excessive hair growth (called hirsutism) or severe acne that doesn't improve with treatment. It can also be shown through blood tests that measure hormone levels, like testosterone.
  • Participants should have menstrual irregularity, which means having 8 or fewer menstrual periods in a year, or having periods that are more than 45 days apart.
  • Participants or their guardians must provide written informed consent to join the study. If the participant is a minor, both the participant's agreement and the guardian's consent are needed.

Who cannot join the trial?

10 criteria

  • Having any other serious health condition that could interfere with the study.
  • Being pregnant or planning to become pregnant during the study period.
  • Currently breastfeeding.
  • Using medications that could affect the study results.
  • Having a history of allergic reactions to the study medication.
  • Participating in another clinical trial at the same time.
  • Having a mental health condition that could affect participation.
  • Being unable to follow the study procedures for any reason.
  • Having a history of substance abuse.
  • Being under the legal age of consent without parental or guardian approval.
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Investigated drugs

  • Spironolactone

    is a medication that helps to reduce the effects of certain hormones in the body. It is often used to treat conditions like high blood pressure and heart failure, but in this trial, it is being used to help manage symptoms of polycystic ovary syndrome (PCOS) by potentially improving ovulation.

  • Pioglitazone

    is a medication that helps to control blood sugar levels. It is commonly used in the treatment of type 2 diabetes. In this trial, it is being used to see if it can help improve ovulation and other symptoms in women with PCOS.

  • Metformin

    is a medication that is also used to control blood sugar levels, especially in people with type 2 diabetes. In this trial, it is being used to help improve ovulation and manage symptoms in women with PCOS.

What is already known about the treatment

  • Spironolactone

    This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating polycystic ovary syndrome (PCOS). It is primarily used to manage conditions related to excess androgen, such as acne and hirsutism. Spironolactone works by blocking androgen receptors and inhibiting the action of male hormones at the molecular level. It is classified as a potassium-sparing diuretic and an anti-androgen.

  • Pioglitazone

    Administered orally, pioglitazone is under investigation for its role in managing PCOS. It is commonly used to improve insulin sensitivity in individuals with type 2 diabetes. The medication functions by activating peroxisome proliferator-activated receptor gamma (PPAR-γ), which helps regulate glucose and lipid metabolism. Pioglitazone is classified as a thiazolidinedione.

  • Metformin

    Taken orally, metformin is being evaluated for its potential benefits in treating PCOS. It is widely used to control blood sugar levels in people with type 2 diabetes. Metformin works by decreasing glucose production in the liver and improving insulin sensitivity. It belongs to the biguanide class of medications.

Investigated diseases

Polycystic Ovary Syndrome (PCOS) – PCOS is a hormonal disorder common among women of reproductive age. It is characterized by irregular menstrual periods, excess androgen levels, and polycystic ovaries. Women with PCOS may experience infrequent or prolonged menstrual cycles and may have difficulty with ovulation. The condition often leads to the development of small collections of fluid (follicles) in the ovaries. Over time, PCOS can contribute to various symptoms such as weight gain, acne, and excessive hair growth. The progression of PCOS can vary, with symptoms sometimes worsening or improving over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518527-29-00Protocol codeSPIOMET4HEALTHEstimated enrolment358 patientsSponsorFundacio Sant Joan De Deu

sourced from the EU Clinical Trials Register and site verification

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