Reproductive Axis Maturation in the Early Post-Menarchal Years

NCT03986021 | Recruiting

• 2 other identifiers: 19011019-E-0110
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Pediatrics; Reproductive Physiological Processes; Adolescent Health; Adolescent Development

Keywords

Menarche; Adolescent; Physiology; Hormones; Natural History

Outcome Measures

Primary Outcomes (1)

• To determine the time from menarche to regular ovulatory cycles, defined as two consecutive ovulatory cycles in girls of variable genetic risk for PCOS

  We hypothesize that the temporal sequence of reproductive maturation will consist of anovulatory cycles (representing a time of unopposed estrogen exposure), ovulatory cycles with a short luteal phase (estrogen with low progesterone exposure), and finally, ovulatory cycles with a normal luteal phase length (estrogen action fully counterbalanced by progesterone action)

  Defined as two consecutive ovulatory cycles with normal (10-14 day) luteal phase length during the first two post-menarchal years

Study Arms (7)

At-risk girls

Girls with first degree relative diagnosed with Polycystic Ovary Syndrome (PCOS) age 8-\<15

early post-menarche girls

Healthy, early post-menarchal girls age 8-\<15

Healthy control women

Women age \>18-34 without PCOS at least 3-years post-menarchal with regular menstrual cycles every 21-35 days

late post-menarche girls

Late post-menarchal girls age 11-\<17.5 (gynecological age 2-5)

Mothers of pediatric study participants

Mothers age 18-65 whose daughter has provided at least one vaginal swab sample for the First Period study.

pre-menarche girls

Healthy, pre-menarchal girls age 8-\<14.5

Women with PCOS

Women diagnosed with PCOS \>18-34 at least 3-years post-menarchal with irregular menstrual cycles

Eligibility Criteria

• Age: 8 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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
• 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

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (1)

NIEHS Clinical Research Unit (CRU)

Research Triangle Park, North Carolina, 27709, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Natalie D Shaw, M.D.

  National Institute of Environmental Health Sciences (NIEHS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

NIEHS Join A Study Recruitment Group

CONTACT

(855) 696-4347; myniehs@nih.gov

Natalie D Shaw, M.D.

CONTACT

(984) 287-3716; natalie.shaw@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: June 14, 2019
• Study Start: December 19, 2019
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-02-20

Locations

US (1)