Reproductive Axis Maturation in the Early Post-Menarchal Years
Recruiting
Observational Study
Reproductive Physiological ProcessesPediatricsAdolescent HealthAdolescent Development
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
8 – 65
Sex
Female
Study type
Observational
Participants needed
400 (estimated)
Sponsor
National Institute of Environmental Health Sciences (NIEHS) · NIH
Who this trial is looking for
This trial is looking for healthy girls aged 8-17.5 to learn how their menstrual cycles develop. Participants will have some medical tests and visits to help understand puberty changes and hormone health.
Are You a Good Fit for This Trial?
Must not be takingBirth control pillsBiotin supplements
I have my first period or am within 6 months of it
I show signs of puberty, like breast development
I have a healthy weight
I have a mother or sister with PCOS
I have irregular menstrual cycles
You may not be able to join if
I am taking or planning to take medications for reproductive hormones
I plan to move more than 60 miles from the study site in the next 2-3 years
I have a chronic medical condition like diabetes or lupus
I have a first-degree relative with a hormonal disorder
I exercise excessively, running more than 20 miles per week
I am pregnant
I have anemia
I have had a hormonal disorder diagnosis
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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).
Trial Locations
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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 plan…
* 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
Mothers of pediatric participants (Activities for 8 weeks / 2 menstrual cycles)
Inclusion Criteria:
* Age \>=18-65 years old
* Biological mother of A Girl's First Period participant
Exclusion Criteria:
* 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
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