RecruitingNCT03986021

Reproductive Axis Maturation in the Early Post-Menarchal Years

Reproductive Axis Maturation in the Early Post-Menarchal Years: A Pilot Study


Sponsor

National Institute of Environmental Health Sciences (NIEHS)

Enrollment

400 participants

Start Date

Dec 19, 2019

Study Type

OBSERVATIONAL

Conditions

Summary

Background: Most adult women with irregular periods of unknown cause report symptoms dating back to early adolescence. This study aims to learn how girls' periods change in the 2 years after their first period. We are also looking at girls who may have a condition called PCOS. This will help researchers learn what healthy puberty looks like and how they can spot signs of hormone problems early on. Objective: To learn how long it takes girls to develop regular menstrual cycles after their first period. Eligibility: Healthy girls ages 8-14 who either (1) haven't had their first period but show signs of puberty, such as breast development and hair in the genital area; or (2) had their first period in the past 6 months Girls at risk for PCOS age 8-14 who have a mom or sister with PCOS Girls with irregular menstrual cycles age 11-17.5 To compare with the girls, we are looking at women \>=18-34 years old with PCOS, Healthy women \>= 18-34 years old without PCOS, and Mothers of pediatric participants age 18-65 Design: Both parents or guardians must allow their daughter to participate. They must attend all study visits with her. Participants will first be screened by phone. Those who qualify will be screened in person. They will have a physical exam. They will give blood and urine samples. They will have an ultrasound of their abdomen. They will fill out questionnaires. They will sit in a BOD POD for 6 minutes: This is an egg- shaped machine that takes body measurements. They have the option to provide DNA samples. Participants will have sets of visits at home or at the clinic about every 6 months. The number of visits in each set will depend on their menstrual cycle. Then they will have a final visit. Visits will include repeats of the screening tests. There are additional parts that participants may choose to be involved in depending on how involved they want to be. At home, participants will collect their urine daily to measure hormones. They will keep a diary of their periods. Adults: Women with known PCOS will complete the same Screening Visit as the girls and will collect dried urine specimens at home for 8 weeks; The Healthy control women group will complete the same Screening Visit as the girls and collect dried urine specimens at home for 2 menstrual cycles; The Mothers of pediatric participants group will complete a Screening Visit (informed consent, urine pregnancy test) and collect vaginal swab specimens at home for 2 menstrual cycles (approx. 8 weeks)....


Eligibility

Sex: FEMALEMin Age: 8 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tracks how the reproductive system matures in girls around the time of their first period (menarche), and also studies women with polycystic ovarian syndrome (PCOS). The hormonal changes that happen in early adolescence are complex, and not fully understood. By monitoring hormone levels, menstrual cycles, and ovarian activity over time, researchers hope to learn what is "normal" development — and what patterns signal problems like PCOS. The study has multiple parts for different groups: girls who haven't yet started their period, girls who recently had their first period, adolescents a few years into their menstrual cycles, adult women with PCOS, and healthy adult women as controls. Each participant group follows a specific monitoring protocol involving hormone blood tests and sometimes ultrasound. You may be eligible if you are: - A girl aged 8–17.5 during different phases of puberty - A woman aged 18–34 with a PCOS diagnosis - A healthy woman aged 18–34 with regular cycles - A biological mother (aged 18–65) of a study participant You may NOT be eligible if: - You are taking or plan to take medications that affect reproductive hormones (e.g., birth control, biotin) - You have a chronic medical condition such as diabetes, cystic fibrosis, or lupus - You are pregnant - You exercise excessively (running more than 20 miles per week) - You plan to move more than 60 miles from the study clinic Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.


Locations(1)

NIEHS Clinical Research Unit (CRU)

Research Triangle Park, North Carolina, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03986021


Related Trials