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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 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.
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
Conditions Studied
Study Locations (1)
North Carolina
- NIEHS Clinical Research Unit (CRU) - Research Triangle Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2019-12-19 |
| Est. Completion | 2029-07-01 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03986021
The ClinicalTrials.gov registry entry for NCT03986021 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,315-participant average among 15 other Pediatrics trials with a reported enrollment target (70% lower). The listed sponsor is National Institute of Environmental Health Sciences (NIEHS), which has 145 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Pediatrics appearing as the primary indexed condition, and to 0 interventions.
NCT03986021 reports 1 study location spanning 1 distinct geographic area - top geographies include 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.
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