Hirsutism

Researchers are investigating whether tirzepatide can improve ovarian dysfunction in premenopausal women with polycystic ovary syndrome (PCOS) who are overweight or have obesity. This phase IV, multi-center, randomized, double-blind, placebo-controlled trial aims to show that tirzepatide at the maximum tolerated dose is better than placebo for improving menstrual irregularity related to PCOS. The study is conducted at five sites in Germany and focuses on women aged 18 to 45 years with PCOS defined by specific criteria.

Researchers are studying how serum kisspeptin levels change throughout pregnancy in women with polycystic ovary syndrome (PCOS). This study aims to understand the relationship between kisspeptin, insulin, glucose, and testosterone levels, and to explore whether kisspeptin can predict gestational diabetes mellitus (GDM) and other pregnancy complications in PCOS patients. The study is observational and focuses on pregnancies affected by PCOS using the 2003 Rotterdam diagnostic criteria. The study includes two groups: pregnant women aged 18 to 40 diagnosed with PCOS before pregnancy, and healthy pregnant women in the same age range without PCOS. Participants will be registered for prenatal check-ups during the first trimester. This is an observational study, so no specific treatments or interventions will be given. Researchers will monitor kisspeptin and related hormone levels at different stages of pregnancy. Participants will be followed throughout pregnancy, with assessments to measure dynamic changes in serum kisspeptin over 40 weeks. The study will also evaluate how kisspeptin levels relate to the development of GDM and insulin resistance. Participants will undergo regular check-ups, laboratory tests, and hormone measurements. The study will help understand hormonal changes in PCOS pregnancies and their potential impact on complications, with a total participation time covering the full pregnancy period.

Researchers are evaluating the safety and effectiveness of baricitinib for treating severe or very severe alopecia areata, a condition causing hair loss, in children aged 6 to less than 18 years. This Phase 3 clinical trial aims to determine how well baricitinib works in this young population, with careful monitoring of outcomes related to hair regrowth and patient well-being. Participants will be randomly assigned to one of three groups: a high dose of baricitinib, a low dose of baricitinib, or a placebo. The study includes four periods: a 5-week screening phase to determine eligibility, a 36-week double-blind treatment period where participants receive their assigned treatment, an approximately 2-year long-term extension to observe longer-term effects, and a 4-week follow-up after treatment ends. Some participants may continue to receive treatment after the extension for up to 180 weeks. During the trial, children will undergo regular assessments including the Severity of Alopecia Tool (SALT) score to measure hair loss, patient-reported outcomes on scalp hair, eyebrow, and eyelash hair, as well as evaluations of anxiety, depression, and quality of life. Blood tests will monitor drug levels and immune response. Participants will be closely followed throughout the study periods to track changes and ensure safety, with the total participation lasting over two years depending on extension eligibility.

Researchers are evaluating the effectiveness of acupuncture compared to metformin, both combined with lifestyle management, in improving glucose control in women with insulin resistance and polycystic ovary syndrome (PCOS). The study aims to see if these treatments improve ovulation, hormone balance, quality of life, and symptoms of anxiety and depression, while also investigating if acupuncture has fewer side effects. They also explore whether these treatments can reverse molecular changes that may help prevent type 2 diabetes. Participants will be randomly assigned to one of three groups: lifestyle management alone, lifestyle management plus acupuncture, or lifestyle management plus metformin. Acupuncture treatments involve inserting sterile needles into specific abdominal and leg acupuncture points related to ovarian and pancreatic function, administered three times weekly for four weeks, then twice weekly for twelve weeks. Metformin is taken orally, starting at a low dose and gradually increasing to 1500 mg daily over 16 weeks. All women receive lifestyle advice on weight management, diet, and exercise at the start. During the study, participants undergo assessments at the start, after 4 months of treatment, and again 4 months post-treatment. These include blood tests measuring insulin sensitivity, glucose levels, hormone levels, and molecular markers from tissue samples. Researchers will also monitor menstrual patterns, ovulation, quality of life, mental health symptoms, eating habits, and treatment side effects. The study lasts 8 months with ongoing evaluations to determine the cost-effectiveness and overall impact of each treatment approach.

Researchers are investigating how progesterone affects luteinizing hormone (LH) pulse frequency during waking and sleep periods in mid- to late pubertal girls, both with and without hyperandrogenism (HA). The study aims to find out if progesterone reduces waking LH pulse frequency more than sleep-associated LH pulse frequency in girls without HA, and whether this effect is less in girls with HA. The study is a randomized, placebo-controlled, double-blind crossover trial involving mid- to late pubertal girls at Tanner breast stage 3 or higher but no more than 2 years after menarche. Participants will attend two 18-hour clinical research unit admissions across separate menstrual cycles, receiving either oral micronized progesterone (0.8 mg/kg at 7 AM, 3 PM, 11 PM, and 7 AM) or placebo. Blood samples will be collected every 10 minutes overnight to measure LH pulses and other hormones. After at least two months, participants will switch treatments for the second admission. Participants will be closely monitored throughout the study with frequent blood tests to characterize LH secretion patterns. The main measure is LH pulse frequency while awake, with sleep LH pulse frequency as a secondary measure. The study includes detailed hormone analysis and statistical modeling to compare effects between girls with and without HA. The total participation includes two inpatient admissions separated by at least two months.

Researchers are studying women with polycystic ovary syndrome (PCOS) to understand how certain proteins called adipokines—specifically leptin, resistin, and omentin-1—differ among women with PCOS with and without insulin resistance, and women without PCOS. This research aims to clarify the role these proteins play in PCOS and its associated metabolic issues, such as cardiovascular risks and endometrial cancer. The study is observational and focuses on metabolic profiles across different groups of women. Participants are divided into three groups: women with PCOS and insulin resistance, women with PCOS without insulin resistance, and women without PCOS who serve as controls. The study measures the concentrations of leptin, resistin, and omentin-1 in fasting blood samples using immunoenzymatic methods (ELISA) and biochemical analysis. These measurements will be compared across the groups to assess differences. During the study, blood samples will be collected from participants to evaluate the concentrations of the selected adipokines. The primary outcomes include comparing resistin, leptin, and omentin-1 levels within six months. Statistical analysis will be done using SPSS software. The study involves women aged 18 to 45, and participation includes fasting blood tests and metabolic assessments, with no treatments administered as part of the study.

Researchers are studying how androgens, a type of sex hormone, may influence nonalcoholic fatty liver disease (NAFLD) in young women, especially those with polycystic ovary syndrome (PCOS). Women with PCOS often have high androgen levels and a higher risk of NAFLD, which can cause liver damage like inflammation or scarring. This observational study aims to compare changes in NAFLD over time between young women with and without PCOS to understand these effects better. The study will follow 150 reproductive-aged women diagnosed with metabolic associated steatohepatitis (MASH), including 125 women with PCOS and 25 without PCOS. Participants will be grouped based on their PCOS status and androgen levels, including those with hyperandrogenism, non-hyperandrogenism, and no PCOS. The research team will assess the relationship between androgen levels, liver injury, visceral fat, and lipid metabolism in these groups. Participants will be monitored over three years, with evaluations including liver stiffness measurements and assessments of visceral adipose tissue at the start and follow-up visits. The study will collect data on liver health progression and fat distribution to explore the connection between androgens and liver disease severity. This research is supported by the National Institutes of Health and conducted by experts at the University of California, San Francisco, and Duke University.

Polycystic ovary syndrome (PCOS) is a common hormone disorder in women that involves insulin resistance, high levels of male hormones, and issues with reproduction. Researchers are studying how different protein sources in meals affect blood sugar, insulin, and appetite in women with PCOS. This study focuses on comparing plant-based protein meals to animal-based protein meals to better understand their immediate effects on metabolism and appetite regulation in this group. Participants will receive two types of test meals after fasting overnight: one meal with 30% energy from plant proteins and another with 30% energy from animal proteins. Each meal contains 350 to 400 calories and must be consumed within 10 minutes. Researchers will then measure appetite and metabolic responses, including energy use and blood markers, for four hours after each meal to compare the effects of the protein sources. During the study, women with PCOS will undergo these meal challenges while researchers collect data on energy expenditure, appetite, plasma amino acids, and appetite-related biomarkers at multiple time points up to 240 minutes after eating. The study is randomized and single-masked, with careful monitoring of participants' responses. The trial aims to provide insights that may guide dietary recommendations to improve metabolic health in women with PCOS. Participation will last for the duration of the meal testing sessions.

Researchers are conducting an observational study to improve understanding of the menstrual cycle and various gynecologic health conditions such as polycystic ovary syndrome (PCOS), infertility, and breast cancer. This study focuses on reproductive health and menstrual patterns in women and aims to gather long-term data to describe these aspects epidemiologically. The study is hosted on the Apple Research app, which participants can use to find, enroll in, and take part in this research. It collects data related to menstrual cycle patterns and the prevalence of gynecologic health conditions over a period of up to 10 years. Participants will engage through the app, providing information about their menstrual cycles and health conditions. The study tracks menstrual cycle patterns and collects epidemiologic data over time, also determining the prevalence of related health issues. This observational approach allows long-term monitoring without administering treatments. The study is expected to continue through November 2029.

Researchers are evaluating the effectiveness of letrozole alone versus letrozole combined with levothyroxine for inducing ovulation in infertile women who have both polycystic ovary syndrome (PCOS) and subclinical hypothyroidism. The study aims to determine if adding levothyroxine improves ovulation rates, pregnancy rates, and live birth rates compared to letrozole alone. The trial is randomized and involves women aged 20 to 40 years with specific diagnostic criteria for PCOS and subclinical hypothyroidism. Participants are assigned to one of two groups. The first group receives letrozole starting at 2.5 mg daily from day 3 to 7 of their menstrual cycle, with doses increasing up to 7.5 mg if ovulation does not occur, for a maximum of six months or until pregnancy. The second group receives the same letrozole dosing plus daily levothyroxine starting at 25 mcg, adjusted based on thyroid-stimulating hormone (TSH) levels to reach normal ranges. Both groups have their ovulation monitored by follicular ultrasound and progesterone levels, and treatment compliance is tracked by pill counts and diaries. During the study, participants attend regular visits for ovulation assessment at the end of each menstrual cycle, with up to six cycles evaluated. Pregnancy and live birth outcomes are followed for about one year. Researchers also monitor menstrual regularity, miscarriage rates, and side effects throughout the study period. If pregnancy occurs, participants receive routine antenatal care. Safety is closely observed, and participants are followed for any multiple pregnancies. The total duration of participation can be up to one year, including treatment and follow-up.