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
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.
To learn how long it takes girls to develop regular menstrual cycles after their first period.
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
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|
|Study Type :||Observational|
|Estimated Enrollment :||75 participants|
|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|
Healthy, early post-menarchal girls age 8-14 years
- 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).
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
|Contact: Imke Kirste||(984) email@example.com|
|United States, North Carolina|
|NIEHS Clinical Research Unit (CRU)||Recruiting|
|Research Triangle Park, North Carolina, United States, 27709|
|Principal Investigator:||Natalie D Shaw, M.D.||National Institute of Environmental Health Sciences (NIEHS)|