Research Triangle Park, NCNCT03986021Now EnrollingIRB Ready

Reproductive Physiological Processes Clinical Trial in Research Triangle Park, NC

Access cutting-edge reproductive physiological processes treatment through this clinical trial at a research site in Research Triangle Park. Study-provided care at no cost to qualified participants.

Sponsored by National Institute of Environmental Health Sciences (NIEHS)

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Expert Care in Research Triangle Park

Access reproductive physiological processes specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related reproductive physiological processes treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Research Triangle Park

    Convenient for NC residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Research Triangle Park site if eligible
  4. 4Begin participation

About This Reproductive Physiological Processes Study in Research Triangle Park

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).

Sponsor: National Institute of Environmental Health Sciences (NIEHS)

Who Can Participate

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Research Triangle Park?

Yes, this clinical trial (NCT03986021) has an active research site in Research Triangle Park, NC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Reproductive Physiological Processes Treatment Options in Research Triangle Park, NC

If you're searching for reproductive physiological processes treatment options in Research Triangle Park, NC, this clinical trial (NCT03986021) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Research Triangle Park research site is actively enrolling participants for this clinical trial. You'll receive care from experienced reproductive physiological processes specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all reproductive physiological processes clinical trials near you to find additional studies recruiting in your area.

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