Reproductive Axis Maturation in the Early Post-Menarchal Years

Launched by NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES (NIEHS) · Jun 13, 2019

Keywords

ClinConnect Summary

This clinical trial, called "Reproductive Axis Maturation in the Early Post-Menarchal Years," is studying how girls' menstrual cycles develop in the two years after they get their first period. The researchers want to understand what normal puberty looks like and how to identify any hormone-related issues early, especially in girls who might be at risk for a condition known as PCOS (polycystic ovary syndrome). Girls aged 8 to 17.5 who either have not started their periods yet or have recently started are being invited to participate, particularly those with family members who have PCOS or those experiencing irregular cycles.

Participants will need to attend several study visits with a parent or guardian and will undergo some health checks like physical exams and blood tests. They'll also keep track of their periods and collect urine samples at home to measure hormone levels. The trial aims to provide valuable insights into menstrual health and development during adolescence, which could help in identifying potential health issues sooner. If you think your daughter might be eligible, participating in this study could contribute to important research while also helping her understand her own body better.

Gender

FEMALE

Eligibility criteria

• * Part 1 - Pre-menarche monitoring ("holding pattern"):
• Inclusion Criteria:
• • Age 8-14.5 years old
• • Healthy weight, defined as having a body weight \>85% of expected (EBW) and a body mass index (BMI) \<99th percentile
• • Some breast development
• • Pre-menarche
• Exclusion Criteria:
• • Taking or planning to take medications that affect reproductive hormones in the next 2 to 3 years (e.g. birth control pills, biotin supplements).
• • Planning to move more than 60 miles from the CRU within the next 2 to 3 years
• • Chronic medical condition, including but not limited to diabetes mellitus, congenital adrenal hyperplasia, cystic fibrosis, sickle cell disease, inflammatory bowel disease, juvenile rheumatoid arthritis, and lupus.
• • First-degree relative with polycystic ovarian syndrome, premature ovarian insufficiency, hypogonadotropic hypogonadism, or other pubertal development disorder
• • Excessive exercise (defined as running \>20 miles per week or its equivalent)
• • Pregnancy
• Part 2 - Post-menarche cycle tracking:
• Inclusion Criteria:
• • Age at menarche 10-14.5 years old
• • Healthy weight, defined as having a body weight \>85% of expected (EBW) and a body mass index (BMI) \<99th percentile
• • Approximately \< 6 months post-menarchal (will typically have completed 4 or fewer menstrual cycles)
• • Biochemical criteria: normal thyroid hormone, prolactin, and testosterone levels
• Exclusion Criteria:
• • Taking or planning to take medications that affect reproductive hormones in the next 2 to 3 years (e.g. birth control pills, biotin supplements).
• • Planning to move more than 60 miles from the CRU within the next 2 to 3 years
• • Chronic medical condition, including but not limited to diabetes mellitus, congenital adrenal hyperplasia, cystic fibrosis, sickle cell disease, inflammatory bowel disease, juvenile rheumatoid arthritis, and lupus.
• • First-degree relative with polycystic ovarian syndrome, premature ovarian insufficiency, hypogonadotropic hypogonadism, or other pubertal development disorder
• • Excessive exercise (defined as running \>20 miles per week or its equivalent)
• • Anemia (defined as hemoglobin \<12.0 g/dl)
• • --Participants with hemoglobin between 11.5 g/dl and 12.0 g/dl may still participate by providing dried blood spots, or no more than 18 ml of blood during any given interval.
• • Pregnancy
• • Part 3 - Intensive monitoring of ovarian follicle growth
• Inclusion Criteria:
• • Age at menarche 10-14.5 years old
• • Healthy weight, defined as having a body weight \>85% of expected (EBW) and a body mass index (BMI) \<99th percentile
• • Within 1 year of menarche
• • Biochemical criteria: normal thyroid hormone, prolactin, and testosterone levels
• Exclusion Criteria:
• • Taking or planning to take medications that affect reproductive hormones in the next 1-2 years (e.g. birth control pills, biotin supplements).
• • Planning to move more than 60 miles from the CRU within the next year
• • Chronic medical condition, including but not limited to diabetes mellitus, congenital adrenal hyperplasia, cystic fibrosis, sickle cell disease, inflammatory bowel disease, juvenile rheumatoid arthritis, and lupus.
• • First-degree relative with polycystic ovarian syndrome, premature ovarian insufficiency, hypogonadotropic hypogonadism, or other pubertal development disorder
• • Excessive exercise (defined as running \>20 miles per week or its equivalent)
• • Anemia (defined as hemoglobin \<12.0 g/dl)
• • --Participants with hemoglobin between 11.5 g/dl and 12.0 g/dl may still participate by providing dried blood spots, or no more than 18 ml of blood during any given interval.
• • Pregnancy
• Part 4 - Late Post-menarche cycle tracking:
• Inclusion Criteria:
• • Age 11-17.5 years old
• • Approximately 2-5 years post-menarchal
• • Biochemical criteria: normal thyroid hormone and prolactin
• Exclusion Criteria:
• • Taking or planning to take medications that affect reproductive hormones in the next 2 to 3 years (e.g. birth control pills, biotin supplements).
• • Planning to move more than 60 miles from the CRU within the next 6 months
• • Chronic medical condition, including but not limited to diabetes mellitus, congenital adrenal hyperplasia, cystic fibrosis, sickle cell disease, inflammatory bowel disease, juvenile rheumatoid arthritis, and lupus.
• • Anemia (defined as hemoglobin \<12.0 g/dl)
• • --Participants with hemoglobin between 11.5 g/dl and 12.0 g/dl may still participate by providing dried blood spots, or no more than 18 ml of blood during any given interval.
• • Pregnancy
• • Adolescent girls, at-risk daughters, or sisters of women with PCOS
• • The girls with mothers or sisters with PCOS group will complete the Screening Visit and Parts 1-3. The same inclusion and exclusion criteria apply for Parts 1, 2, and 3 as stated above except that these individuals must have a first-degree relative with PCOS and they can have high androgen levels, excess body hair, and severe acne at screening.
• • Women with known PCOS (activities for 8 weeks only)
• Inclusion Criteria:
• • Age \>=18-34 years old
• • PCOS diagnosis
• • at least 3-years post-menarchal with irregular menstrual cycles
• • Biochemical (blood) or clinical signs of high androgen levels
• Exclusion Criteria:
• • Cannot be taking any medications that affect reproductive or metabolic hormones (e.g. birth control pill, biotin supplements, spironolactone, metformin).
• • Chronic medical condition, including but not limited to diabetes mellitus, congenital adrenal hyperplasia, cystic fibrosis, sickle cell disease, inflammatory bowel disease, juvenile rheumatoid arthritis, and lupus.
• • Pregnancy
• • Healthy control women (Activities x 2 menstrual cycles)
• Inclusion Criteria:
• • Age \>=18-34 years old
• • at least 3-years post-menarchal with regular menstrual cycles every 21-35 days
• Exclusion Criteria:
• • Cannot be taking any medications that affect reproductive or metabolic hormones (e.g. birth control pill, biotin supplements, spironolactone, metformin).
• • Chronic medical condition, including but not limited to diabetes mellitus, congenital adrenal hyperplasia, cystic fibrosis, sickle cell disease, inflammatory bowel disease, juvenile rheumatoid arthritis, and lupus.
• • PCOS diagnosis or first-degree relative with disorder
• • Pregnancy