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Investigation of Female Reproductive Hormone Dynamics During Adolescence

NCT ID: NCT02486757

Last Updated: 2018-12-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-03-01

Brief Summary

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Irregular menstrual cycles are common in girls for several years after their first menstrual period. The cause of abnormal menstrual cycles during this time is not well-understood. The purpose of this study is to: 1) monitor girls during a menstrual cycle (with blood and urine sampling and serial pelvic ultrasounds) to identify those girls who do not ovulate (release of an egg from the ovary), and 2) determine whether cycles can be corrected by treating girls with a short course of low-dose estrogen and progesterone.

Detailed Description

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Conditions

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Menstruation Disturbances

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Interventional

estradiol 50 mcg transdermal patch x 7 days oral micronized progesterone 0.5 mg/kg/dose TID x 7 days

Group Type EXPERIMENTAL

micronized progesterone

Intervention Type DRUG

transdermal estradiol

Intervention Type DRUG

Interventions

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micronized progesterone

Intervention Type DRUG

transdermal estradiol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* no more than 3 ½ years postmenarchal

Exclusion Criteria

* Subjects currently on or previously treated with medications that may affect reproductive hormones (eg birth control pills).
* Subjects with severe acne or hirsutism
* Subjects who exercise excessively (running \> 20 miles/week or its equivalent)
* Subjects with any of the following medical conditions: diabetes, hypertension, hyperlipidemia, valvular heart disease, lupus, rheumatoid arthritis, migraine headaches with aura, undiagnosed breast mass, inflammatory bowel disease, gallbladder disease, sickle cell disease, or thrombophilia.
* Current smoker
* History of deep venous thrombosis or pulmonary embolism in subject or first-degree relative
Minimum Eligible Age

12 Years

Maximum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Janet E. Hall, MD

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Janet Hall, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Reproductive Endocrine Unit, Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Ortega MT, Carlson L, McGrath JA, Kangarloo T, Adams JM, Sluss PM, Lambert-Messerlian G, Shaw ND. AMH is Higher Across the Menstrual Cycle in Early Postmenarchal Girls than in Ovulatory Women. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1762-71. doi: 10.1210/clinem/dgaa059.

Reference Type DERIVED
PMID: 32016427 (View on PubMed)

Sun BZ, Kangarloo T, Adams JM, Sluss P, Chandler DW, Zava DT, McGrath JA, Umbach DM, Shaw ND. The Relationship Between Progesterone, Sleep, and LH and FSH Secretory Dynamics in Early Postmenarchal Girls. J Clin Endocrinol Metab. 2019 Jun 1;104(6):2184-2194. doi: 10.1210/jc.2018-02400.

Reference Type DERIVED
PMID: 30649404 (View on PubMed)

Sun BZ, Kangarloo T, Adams JM, Sluss PM, Welt CK, Chandler DW, Zava DT, McGrath JA, Umbach DM, Hall JE, Shaw ND. Healthy Post-Menarchal Adolescent Girls Demonstrate Multi-Level Reproductive Axis Immaturity. J Clin Endocrinol Metab. 2019 Feb 1;104(2):613-623. doi: 10.1210/jc.2018-00595.

Reference Type DERIVED
PMID: 30289507 (View on PubMed)

Other Identifiers

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2013P-000513

Identifier Type: -

Identifier Source: org_study_id