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Investigation of Female Reproductive Hormone Dynamics During Adolescence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02486757
Recruitment Status : Completed
First Posted : July 1, 2015
Results First Posted : December 24, 2018
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Janet E. Hall, MD, Massachusetts General Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Menstruation Disturbances Drug: micronized progesterone Drug: transdermal estradiol Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Investigation of Female Reproductive Hormone Dynamics During Adolescence
Study Start Date : April 2015
Actual Primary Completion Date : March 1, 2016
Actual Study Completion Date : March 1, 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Interventional
estradiol 50 mcg transdermal patch x 7 days oral micronized progesterone 0.5 mg/kg/dose TID x 7 days
 Drug: micronized progesterone
Drug: transdermal estradiol


Outcome Measures
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Primary Outcome Measures :
  1. Ovulation in Cycle 2 [ Time Frame: 20-40 days ]
    serum progesterone > 3 ng/ml or presence of corpus luteum on pelvic ultrasound


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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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): NCT02486757


Locations
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United States, Massachusetts
Reproductive Endocrine Unit, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Janet Hall, MD Massachusetts General Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Janet E. Hall, MD, Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02486757    
Other Study ID Numbers: 2013P-000513
First Posted: July 1, 2015    Key Record Dates
Results First Posted: December 24, 2018
Last Update Posted: December 24, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Menstruation Disturbances
Pathologic Processes
Estradiol
Progesterone
Estrogens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Progestins