Reproductive Axis Maturation in the Early Post-Menarchal Years

Part of paid clinical trials in Research Triangle Park, North Carolina.

Sponsor
National Institute of Environmental Health Sciences (NIEHS)
Study ID
NCT03986021
Status
Recruiting
Apply to this trial

Conditions

  • Adolescent Development
  • Adolescent Health
  • Pediatrics
  • Reproductive Physiological Processes

Eligibility Criteria

Sex
FEMALE
Age
8 Years - 65 Years
Healthy Volunteers
Accepted

Study Details

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).

Key Dates

Start date
Dec 19, 2019
Status verified
Feb 2026
Primary completion
Jul 1, 2029
Completion
Jul 1, 2029

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: At-risk girls
    Girls with first degree relative diagnosed with Polycystic Ovary Syndrome (PCOS) age 8-\<15
  • Arm: early post-menarche girls
    Healthy, early post-menarchal girls age 8-\<15
  • Arm: Healthy control women
    Women age \>18-34 without PCOS at least 3-years post-menarchal with regular menstrual cycles every 21-35 days
  • Arm: late post-menarche girls
    Late post-menarchal girls age 11-\<17.5 (gynecological age 2-5)
  • Arm: Mothers of pediatric study participants
    Mothers age 18-65 whose daughter has provided at least one vaginal swab sample for the First Period study.
  • Arm: pre-menarche girls
    Healthy, pre-menarchal girls age 8-\<14.5
  • Arm: Women with PCOS
    Women diagnosed with PCOS \>18-34 at least 3-years post-menarchal with irregular menstrual cycles

Primary Outcome Measure

To determine the time from menarche to regular ovulatory cycles, defined as two consecutive ovulatory cycles in girls of variable genetic risk for PCOS [ Time Frame: Defined as two consecutive ovulatory cycles with normal (10-14 day) luteal phase length during the first two post-menarchal years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NIEHS Clinical Research Unit (CRU)Research Triangle ParkNorth Carolina27709
NIEHS Join A Study Recruitment Group
[email protected]
855-696-4347

Find similar trials in Research Triangle Park, NC

By research site
NIEHS Clinical Research Unit (CRU)· Research Triangle Park, NC

Related Studies