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 8-14.5 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 |
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Reproductive Physiological Processes Pediatrics Adolescent Health Adolescent Developement |
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 |
Actual Study Start Date : | December 19, 2019 |
Estimated Primary Completion Date : | December 31, 2022 |
Estimated Study Completion Date : | December 31, 2022 |
Group/Cohort |
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Post-menarche girls
Healthy, early post-menarchal girls age 10-14
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Ages Eligible for Study: | 8 Years to 15 Years (Child) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Part 2 - Post-menarche cycle tracking:
INCLUSION CRITERIA:
Biochemical criteria: normal thyroid hormone, prolactin, and testosterone levels
EXCLUSION CRITERIA:
Anemia (defined as hemoglobin <12.0 g/dl)
--Participants with hemoglobin between 11.5 g/dl and 12.0 g/dl may still participate by providing dried blood spots, or no more than 18ml of blood during any given interval.
In some cases, particularly in those participants with short menstrual cycle lengths, the participant may have her first cycle monitoring visit before the results from all the laboratory tests from the screening visit are available. Some of these tests take > 5-7 days to complete. The tests are necessary for eligibility but are not related to participant safety. If the results are abnormal, the participant will be withdrawn from the study at that time.
If a potential participant meets all eligibility criteria for Part 1 during the initial phone screening, she and at least one parent or guardian will verbally assent and consent, respectively, to receive regular communications from the study team (i.e. monthly phone calls, emails, and text messages. The purpose of these communications is follow-up with the participant to determine when she can enroll in Part 2 of the study. She will not participate in any clinical study procedures in Part 2 as detailed below until she has her first period, at which time she and/or her parent or guardian will notify the study team. This will allow study staff to enroll girls at the desired (young) gynecological age and allow initial study visits to be scheduled in alignment with the girls' menstrual cycles.
Contact: NIEHS Join A Study Recruitment Group | (855) 696-4347 | myniehs@nih.gov |
United States, North Carolina | |
NIEHS Clinical Research Unit (CRU) | Recruiting |
Research Triangle Park, North Carolina, United States, 27709 | |
Contact: NIEHS Join A Study Recruitment Group 855-696-4347 myniehs@nih.gov |
Principal Investigator: | Natalie D Shaw, M.D. | National Institute of Environmental Health Sciences (NIEHS) |
Tracking Information | |||||
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First Submitted Date | June 13, 2019 | ||||
First Posted Date | June 14, 2019 | ||||
Last Update Posted Date | April 20, 2021 | ||||
Actual Study Start Date | December 19, 2019 | ||||
Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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).
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Reproductive Axis Maturation in the Early Post-Menarchal Years | ||||
Official Title | Reproductive Axis Maturation in the Early Post-Menarchal Years: A Pilot Study | ||||
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 8-14.5 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. |
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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. | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Healthy early post-menarchal girls age 8 less than or equal to 15 years. | ||||
Condition |
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Intervention | Not Provided | ||||
Study Groups/Cohorts | Post-menarche girls
Healthy, early post-menarchal girls age 10-14
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
75 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | December 31, 2022 | ||||
Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Part 2 - Post-menarche cycle tracking: INCLUSION CRITERIA:
Biochemical criteria: normal thyroid hormone, prolactin, and testosterone levels EXCLUSION CRITERIA:
In some cases, particularly in those participants with short menstrual cycle lengths, the participant may have her first cycle monitoring visit before the results from all the laboratory tests from the screening visit are available. Some of these tests take > 5-7 days to complete. The tests are necessary for eligibility but are not related to participant safety. If the results are abnormal, the participant will be withdrawn from the study at that time. If a potential participant meets all eligibility criteria for Part 1 during the initial phone screening, she and at least one parent or guardian will verbally assent and consent, respectively, to receive regular communications from the study team (i.e. monthly phone calls, emails, and text messages. The purpose of these communications is follow-up with the participant to determine when she can enroll in Part 2 of the study. She will not participate in any clinical study procedures in Part 2 as detailed below until she has her first period, at which time she and/or her parent or guardian will notify the study team. This will allow study staff to enroll girls at the desired (young) gynecological age and allow initial study visits to be scheduled in alignment with the girls' menstrual cycles. |
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Sex/Gender |
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Ages | 8 Years to 15 Years (Child) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts |
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Listed Location Countries | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03986021 | ||||
Other Study ID Numbers | 190110 19-E-0110 |
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Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement | Not Provided | ||||
Responsible Party | National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) ) | ||||
Study Sponsor | National Institute of Environmental Health Sciences (NIEHS) | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | National Institutes of Health Clinical Center (CC) | ||||
Verification Date | April 16, 2021 |