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Investigation of Female Reproductive Hormone Dynamics During Adolescence

Primary Purpose

Menstruation Disturbances

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
micronized progesterone
transdermal estradiol
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Menstruation Disturbances

Eligibility Criteria

12 Years - 16 Years (Child)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Reproductive Endocrine Unit, Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional

Arm Description

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

Outcomes

Primary Outcome Measures

Ovulation in Cycle 2
serum progesterone > 3 ng/ml or presence of corpus luteum on pelvic ultrasound

Secondary Outcome Measures

Full Information

First Posted
June 24, 2015
Last Updated
June 18, 2018
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02486757
Brief Title
Investigation of Female Reproductive Hormone Dynamics During Adolescence
Official Title
Investigation of Female Reproductive Hormone Dynamics During Adolescence
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
March 1, 2016 (Actual)
Study Completion Date
March 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menstruation Disturbances

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional
Arm Type
Experimental
Arm Description
estradiol 50 mcg transdermal patch x 7 days oral micronized progesterone 0.5 mg/kg/dose TID x 7 days
Intervention Type
Drug
Intervention Name(s)
micronized progesterone
Intervention Type
Drug
Intervention Name(s)
transdermal estradiol
Primary Outcome Measure Information:
Title
Ovulation in Cycle 2
Description
serum progesterone > 3 ng/ml or presence of corpus luteum on pelvic ultrasound
Time Frame
20-40 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet Hall, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reproductive Endocrine Unit, Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32016427
Citation
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.
Results Reference
derived
PubMed Identifier
30649404
Citation
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.
Results Reference
derived
PubMed Identifier
30289507
Citation
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.
Results Reference
derived

Learn more about this trial

Investigation of Female Reproductive Hormone Dynamics During Adolescence

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