NCT03986021

Reproductive Axis Maturation in the Early Post-Menarchal Years

Recruiting now Last updated 14 April 2026

What this trial tests

trial in Reproductive Physiological Processes in 400 participants. Currently enrolling.

Timeline

19 December 2019

Primary endpoint
1 July 2029

1 July 2029

Quick facts

Lead sponsor	National Institute of Environmental Health Sciences (NIEHS)
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	400
Start date	19 December 2019
Primary completion	1 July 2029
Estimated completion	1 July 2029
Sites	1 location across United States

Conditions studied

• Reproductive Physiological Processes — all drugs for Reproductive Physiological Processes →
• Pediatrics — all drugs for Pediatrics →
• Adolescent Health — all drugs for Adolescent Health →
• Adolescent Development — all drugs for Adolescent Development →

Sponsor

National Institute of Environmental Health Sciences (NIEHS)

Who can join

Adults 8 to 65, female only, with Reproductive Physiological Processes or Pediatrics. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.