Girls' period patterns under the microscope: a quest to decode healthy puberty
NCT ID NCT03986021
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 7 times
Summary
This study follows healthy girls ages 8-14 and teens with irregular periods to learn how their menstrual cycles become regular after their first period. Researchers also include girls at risk for PCOS and compare them to women with and without PCOS. The goal is to understand normal puberty and find early signs of hormone problems.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2019
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Healthy early post-menarchal girls age 8-\<15 years; PCOS women and girls with first degree relatives with PCOS; Healthy women 18-34 years; Late post-menarchal girls age 11-\<17.5; healthy pre-menarchal girls age 8-\<14.5; mothers of pediatric participants age 18-65
- Ages
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8 to 65 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Contacts and locations
Locations
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NIEHS Clinical Research Unit (CRU)
RECRUITINGResearch Triangle Park, North Carolina, 27709, United States
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