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Reproductive Axis Maturation in the Early Post-Menarchal Years

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ClinicalTrials.gov Identifier: NCT03986021
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) )

Brief 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. 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

Design:

A parent or guardian 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.

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.

At home, participants will collect their urine daily to measure hormones. They will keep a diary of their periods.

The study will last about 2 years.


Condition or disease
Reproductive Physiological Processes Pediatrics Adolescent Health Adolescent Developement

Detailed Description:
The broad goal of these studies is to determine the physiologic and pathophysiologic underpinnings of irregular menstrual cycles among adolescents in the early post-menarchal period. Irregular menstruation affects > 2.5 million reproductive-age women in the US each year1. Most adult women with oligomenorrhea of unknown etiology reporting symptoms dating back to early adolescence. While a period of cycle irregularity is well-described in the first few years after menarche, a lack of understanding of the basic mechanisms of normal reproductive axis development in the post-menarchal female has hampered our ability to distinguish abnormal from normal developmental trajectories. Moreover, the commonly held belief that menstrual irregularity among teenage girls is normal has also delayed detection of pathology in reproductive development, precluding institution of early preventative strategies to curtail future reproductive morbidity.

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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reproductive Axis Maturation in the Early Post-Menarchal Years: A Pilot Study
Estimated Study Start Date : August 21, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Group/Cohort
Post-menarche girls
Healthy, early post-menarchal girls age 8-14 years



Primary Outcome Measures :
  1. To determine the time from menarche to regular ovulatory cycles, defined as two consecutive ovulatory cycles with normal (10-14 day) luteal phase length. [ Time Frame: Defined as two consecutive ovulatory cycles with normal (10-14 day) luteal phase length during the first two post-menarchal years ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 14 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy early post-menarchal girls age 8-14 years.
Criteria
  • Part 1-Pre-menarche monitoring (holding pattern):

INCLUSION CRITERIA:

  • Age 8-14 years old
  • Healthy weight, defined as having a body weight >85% of expected (EBW) and a body mass index (BMI) <99th%
  • Some breast development and body hair in pelvic region
  • Pre-menarche

EXCLUSION CRITERIA:

  • Taking or planning to take medications that affect reproductive hormones in the next 2 years (e.g. birth control pills).
  • Planning to move more than 60 miles from the CRU within the next 2 years
  • Chronic medical condition, including but not limited to diabetes mellitus, congenital adrenal hyperplasia, cystic fibrosis, sickle cell disease, inflammatory bowel disease, juvenile rheumatoid arthritis, and lupus.
  • First-degree relative with polycystic ovarian syndrome, premature ovarian insufficiency, hypogonadotropic hypogonadism, or other pubertal development disorder
  • Excessive exercise (defined as running >20 miles per week or its equivalent)
  • Pregnancy

Part 2 - Post-menarche cycle tracking:

INCLUSION CRITERIA:

  • Age 8-14 years old
  • Healthy weight, defined as having a body weight >85% of expected (EBW) and a body mass index (BMI) <99th%
  • Approximately less than or equal to 6 months post-menarchal (will typically have completed 4 or fewer menstrual cycles)

Biochemical criteria: normal thyroid hormone, prolactin, and testosterone levels

EXCLUSION CRITERIA:

  • Taking or planning to take medications that affect reproductive hormones in the next 2 years (e.g. birth control pills).
  • Planning to move more than 60 miles from the CRU within the next 2 years
  • Chronic medical condition, including but not limited to diabetes mellitus, congenital adrenal hyperplasia, cystic fibrosis, sickle cell disease, inflammatory bowel disease, juvenile rheumatoid arthritis, and lupus.
  • First-degree relative with polycystic ovarian syndrome, premature ovarian insufficiency, hypogonadotropic hypogonadism, or other pubertal development disorder
  • Excessive exercise (defined as running >20 miles per week or its equivalent)
  • Anemia (defined as hemoglobin <12.5 g/dl for Caucasians and Hispanics, < 12.0 g/dl for African Americans)
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986021


Contacts
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Contact: Imke Kirste (984) 287-4424 imke.kirste@nih.gov

Locations
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United States, North Carolina
NIEHS Clinical Research Unit (CRU) Recruiting
Research Triangle Park, North Carolina, United States, 27709
Sponsors and Collaborators
National Institute of Environmental Health Sciences (NIEHS)
Investigators
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Principal Investigator: Natalie D Shaw, M.D. National Institute of Environmental Health Sciences (NIEHS)

Additional Information:
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Responsible Party: National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier: NCT03986021     History of Changes
Other Study ID Numbers: 190110
19-E-0110
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 7, 2019

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) ):
Menarche
Adolescent
Physiology
Hormones