Actively Recruiting
Reproductive Axis Maturation in the Early Post-Menarchal Years
Led by National Institute of Environmental Health Sciences (NIEHS) · Updated on 2026-05-01
400
Participants Needed
1
Research Sites
497 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)....
CONDITIONS
Official Title
Reproductive Axis Maturation in the Early Post-Menarchal Years
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Girls aged 8 to 14.5 years with some breast development who have not yet started menstruating
- Girls aged 10 to 14.5 years within 6 months after their first period with normal thyroid, prolactin, and testosterone levels
- Girls aged 11 to 17.5 years approximately 2 to 5 years post-menarchal with normal thyroid hormone and prolactin
- Girls aged 8 to 14 years who have a mother or sister with PCOS
- Women aged 18 to 34 years with a PCOS diagnosis, at least 3 years post-menarchal with irregular cycles and signs of high androgen levels
- Healthy women aged 18 to 34 years, at least 3 years post-menarchal with regular menstrual cycles every 21-35 days
- Mothers of pediatric participants aged 18 to 65 years
You will not qualify if you...
- Taking or planning to take medications affecting reproductive hormones within the next 1-3 years (e.g., birth control pills, biotin supplements)
- Planning to move more than 60 miles from the clinical research unit within the study period
- Having chronic medical conditions such as diabetes, congenital adrenal hyperplasia, cystic fibrosis, sickle cell disease, inflammatory bowel disease, juvenile rheumatoid arthritis, or lupus
- Having a first-degree relative with PCOS, premature ovarian insufficiency, hypogonadotropic hypogonadism, or other pubertal development disorders (except for girls at genetic risk for PCOS)
- Excessive exercise defined as running more than 20 miles per week or equivalent
- Pregnancy
- Anemia defined as hemoglobin less than 12.0 g/dl (participants with hemoglobin between 11.5 and 12.0 g/dl may participate with limited blood draw)
- For healthy control women, diagnosis of PCOS or first-degree relative with the disorder
AI-Screening
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Trial Site Locations
Total: 1 location
1
NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina, United States, 27709
Actively Recruiting
Research Team
N
NIEHS Join A Study Recruitment Group
CONTACT
N
Natalie D Shaw, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
7
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