Clinical trials for Polycystic Ovarian Syndrome
There are currently 5 clinical trials investigating different treatments for Polycystic Ovarian Syndrome. These studies are testing medications such as letrozole, gonadotropins, metformin, acupuncture, tirzepatide, spironolactone, and pioglitazone to help manage symptoms like irregular periods, fertility issues, and insulin resistance in women with this condition.
Clinical trial locations
- Austria
- Denmark
- Finland
- Germany
- Italy
- Netherlands
- Norway
- Spain
- Sweden
Study on Letrozole and Gonadotropins for Women with Polycystic Ovary Syndrome (PCOS) to Improve Live Birth Rates
This trial is being conducted in the Netherlands and focuses on helping women with PCOS who wish to become pregnant. The study compares two different fertility treatments to see which one works better at increasing the chances of having a baby.
Who can participate: Women between 18 and 43 years old who have been diagnosed with PCOS and have successfully ovulated for six cycles while taking letrozole are eligible. Participants must be couples or single women who want to have a child.
Who cannot participate: Men cannot participate in this study. Women who do not have PCOS or who belong to vulnerable populations are not eligible.
What the study involves: Participants will be randomly assigned to either continue taking letrozole tablets or switch to gonadotropin injections. Letrozole is an oral medication that helps stimulate egg release, while gonadotropins are hormones given by injection that directly stimulate the ovaries. The study lasts up to eight months, during which participants will be monitored for pregnancy and live birth outcomes.
The main goal is to determine which treatment is more effective at helping women achieve a successful pregnancy resulting in a live birth. Throughout the study, participants will keep a medication diary and complete questionnaires about their quality of life and mental health. The study will also look at pregnancy complications and cost-effectiveness of the treatments.
Study on Acupuncture and Metformin for Improving Insulin Sensitivity in Women with Polycystic Ovary Syndrome
This Swedish trial explores two different approaches to improving how the body responds to insulin in women with PCOS. Many women with this condition struggle with insulin resistance, which affects blood sugar control.
Who can participate: Women aged 18 to 40 years with a PCOS diagnosis according to the Rotterdam criteria can join. Participants must have a Body Mass Index between 25 and 45 (or 23 to 37.5 for Chinese women). They should have symptoms like excessive hair growth or acne, irregular periods, and polycystic ovaries visible on ultrasound.
Who cannot participate: Women who have serious medical conditions, are pregnant or planning pregnancy during the study, or are taking medications that affect insulin sensitivity (other than metformin) cannot participate. Those with a history of allergic reactions to metformin, recent participation in other trials, drug or alcohol abuse, or certain mental health conditions are also excluded.
What the study involves: Participants will be divided into three groups. One group receives acupuncture along with lifestyle advice, another takes metformin tablets with lifestyle advice, and the third group only receives lifestyle advice. The treatment lasts four months. Throughout the study, researchers will measure insulin sensitivity using blood tests including oral glucose tolerance tests. They will also assess changes in hormone levels, metabolic markers, and quality of life.
The study investigates whether acupuncture, a traditional therapy involving thin needles inserted at specific body points, can help improve insulin sensitivity similarly to metformin, a medication commonly used for blood sugar control.
Study on Metformin and Metformin Hydrochloride for Overweight Adults with Polycystic Ovary Syndrome
This Finnish study compares two different daily doses of metformin to see if a lower dose can be just as effective as a higher dose for managing PCOS symptoms in overweight women.
Who can participate: Women aged 18 to 37 years with a PCOS diagnosis and a Body Mass Index between 25 and 40 can join. Participants must be willing to sign informed consent and follow all trial procedures.
Who cannot participate: Women outside the specified age range, those who are not overweight, and those without PCOS cannot participate. Men are also excluded from this women-only study.
What the study involves: Participants will be randomly assigned to take either 1,500 mg or 2,250 mg of metformin daily in tablet form for 48 weeks. The study will monitor various health indicators including weight changes, hormone levels like testosterone, and metabolic markers such as fasting glucose and insulin levels. Researchers will also track menstrual regularity, side effects like nausea or abdominal pain, and overall quality of life.
The goal is to determine if the lower dose provides similar benefits with potentially fewer side effects, which could lead to improved treatment strategies for women with PCOS.
Study on Tirzepatide for Women with Overweight or Obesity and Polycystic Ovary Syndrome (PCOS)
This German trial tests whether tirzepatide, a medication that helps regulate blood sugar and promotes weight loss, can help normalize menstrual cycles in women with PCOS who are overweight or have obesity.
Who can participate: Women aged 18 to 45 years with PCOS, a Body Mass Index of 27 or higher, and irregular periods can join. Participants must be at least three years past their first menstrual period, have high male hormone levels in blood tests or visible signs like excess facial hair, and be willing to use non-hormonal birth control methods throughout the study.
Who cannot participate: Women who are pregnant, planning pregnancy, or breastfeeding cannot participate. Those with type 1 or 2 diabetes, recent heart attack or stroke, severe kidney or liver disease, pancreatitis, or a personal or family history of certain thyroid cancers are also excluded. Women taking weight loss medications or who have had weight loss surgery cannot join.
What the study involves: Participants will self-inject either tirzepatide or placebo once weekly for 72 weeks (approximately 1.5 years). The dose of tirzepatide will gradually increase from 2.5 mg to a maximum of 15 mg based on individual tolerance. Throughout the study, participants must avoid hormonal contraceptives and use barrier methods like condoms instead.
Regular monitoring includes blood tests to measure hormone levels, tracking menstrual periods, measuring weight and body composition, and completing quality of life questionnaires. The main focus is on whether the medication can help establish regular menstrual cycles, defined as cycles between 21 and 35 days long or more than 8 cycles per year.
Study on the Effects of Spironolactone, Pioglitazone, and Metformin for Adolescent Girls and Young Women with Polycystic Ovary Syndrome (PCOS)
This multi-country trial taking place in Spain, Denmark, Norway, Austria, and Italy tests a combination treatment called SPIOMET for adolescent girls and young women with PCOS. The treatment combines three medications in one tablet.
Who can participate: Adolescent girls and young women between 12.1 and 23.9 years old can join if it has been at least two years since their first menstrual period. Participants must show signs of excess male hormones through physical symptoms like excessive hair growth or severe acne, or through blood tests showing high testosterone levels. They should also have menstrual irregularity, meaning eight or fewer periods per year or periods more than 45 days apart.
Who cannot participate: Those with other serious health conditions, pregnancy, plans to become pregnant during the study, or current breastfeeding cannot participate. Women using medications that could affect study results, those with allergies to the study medication, participation in another trial simultaneously, certain mental health conditions, substance abuse history, or inability to follow study procedures are also excluded.
What the study involves: Participants receive tablets containing a fixed combination of spironolactone, pioglitazone, and metformin. Spironolactone helps reduce the effects of male hormones, pioglitazone helps control blood sugar levels, and metformin also helps manage blood sugar while potentially improving ovulation.
Regular follow-up visits monitor ovulation rates, menstrual regularity, and any side effects. The study assesses weight, height, blood pressure, and hormone levels through blood tests. The main goal is to evaluate how effective and safe this three-drug combination is for normalizing ovulation and improving other PCOS symptoms in young women.
Summary
These five clinical trials represent diverse approaches to managing Polycystic Ovarian Syndrome across Europe. The studies are distributed across nine countries, with one trial taking place in multiple locations (Spain, Denmark, Norway, Austria, and Italy).
Several trials focus on metformin, either alone or in combination with other medications, reflecting its established role in PCOS treatment. The studies target different aspects of the condition: fertility and live birth rates, insulin sensitivity, weight management, and ovarian function normalization. Notably, one study specifically targets adolescent girls and young women, addressing the need for age-appropriate treatment approaches.
The trials investigate both traditional pharmaceutical approaches and alternative therapies like acupuncture. Treatment durations vary from four months to 72 weeks, with some studies focusing on short-term metabolic improvements and others on long-term reproductive outcomes. Most trials include quality of life assessments, recognizing that PCOS affects multiple aspects of women’s wellbeing beyond physical symptoms.
