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Reproductive Axis Maturation in the Early Post-Menarchal Years

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 296 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor Eligibility criteria revised
  2. Minor Eligibility criteria expanded, about 58 words
  3. Minor 19 versions Re-verified since Oct 31, 2025, no change to tracked fieldsv276-v294
  4. Minor Enrollment target: 350 to 400v275
  5. Minor Study arms: 6 to 7v274
  6. Minor 27 versions Re-verified since Sep 20, 2024, no change to tracked fieldsv247-v273
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT03986021
Lead Sponsor National Institute of Environmental Health Sciences (NIEHS)
Conditions
(from sponsor)
Reproductive Physiological Processes, Pediatrics, Adolescent Health, Adolescent Development
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov