Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT03986021 · ClinicalTrials.gov registry record

Reproductive Axis Maturation in the Early Post-Menarchal Years

A clinical trial of Pediatrics and Adolescent Development, sponsored by National Institute of Environmental Health Sciences (NIEHS).

Recruiting
Registry status
400
Enrollment target
1
Study location

NCT03986021: Recruiting study of Pediatrics and Adolescent Development, sponsored by National Institute of Environmental Health Sciences (NIEHS).

NCT03986021 is a study of Pediatrics and Adolescent Development that is actively recruiting participants, run by National Institute of Environmental Health Sciences (NIEHS). The registered enrollment target is 400 participants, below the 1,315-participant average among 15 other Pediatrics trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT03986021, a study of Pediatrics and Adolescent Development, is actively recruiting participants, sponsored by National Institute of Environmental Health Sciences (NIEHS).

RECRUITING
Registry status
400 participants
Enrollment target
1
Study location

Study 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 d

Primary Outcome

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)

Study Locations (1)

North Carolina

  • NIEHS Clinical Research Unit (CRU) - Research Triangle Park

Trial Details

FieldValue
Enrollment Target 400 participants
Start Date 2019-12-19
Est. Completion 2029-07-01

What NCT03986021 shows while recruiting

NCT03986021 is an observational study that tracks outcomes without assigning an intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 1,315-participant average among 15 other Pediatrics trials with a reported enrollment target (70% lower).

The record links to 4 conditions, with Pediatrics appearing as the primary indexed condition, and to 0 interventions.

NCT03986021 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT03986021 about?

NCT03986021 is a clinical study titled "Reproductive Axis Maturation in the Early Post-Menarchal Years". 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 resear...

What is the current status of trial NCT03986021?

This trial is currently recruiting. The enrollment target is 400 participants. The study started on 2019-12-19. Estimated completion is 2029-07-01.

What conditions does trial NCT03986021 study?

This clinical trial studies the following conditions: Pediatrics, Adolescent Development, Adolescent Health, Reproductive Physiological Processes.

Who is sponsoring clinical trial NCT03986021?

This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 145 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03986021 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Pediatrics

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03986021's enrollment target sits among peer trials

400 4th of 15 higher than 12 of 15 other Pediatrics trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pediatrics trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT01665326 · 400 participants

    Determination of CRIM Status and Longitudinal Follow-up of Individuals With Pompe Disease

  • NCT02108054 · 400 participants · NA

    Behavioral and Functional Task Development, Implementation, and Testing

  • NCT02216500 · 400 participants · NA

    Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy

  • NCT02250352 · 400 participants

    Core Biopsies for Establishing a Breast Tumor Tissue Repository

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT03986021, the US trial registry maintained by the National Library of Medicine. NCT03986021 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.