NCT02486757

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Apr 2015

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

December 24, 2018

Completed
Last Updated

December 24, 2018

Status Verified

June 1, 2018

Enrollment Period

11 months

First QC Date

June 24, 2015

Results QC Date

June 18, 2018

Last Update Submit

June 18, 2018

Conditions

Menstruation Disturbances

Outcome Measures

Primary Outcomes (1)

  • Ovulation in Cycle 2

    serum progesterone \> 3 ng/ml or presence of corpus luteum on pelvic ultrasound

    20-40 days

Study Arms (1)

Interventional

EXPERIMENTAL

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

Drug: micronized progesteroneDrug: transdermal estradiol

Interventions

micronized progesteroneDRUG
Interventional
transdermal estradiolDRUG
Interventional

Eligibility Criteria

Age12 Years - 16 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • no more than 3 ½ years postmenarchal

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive Endocrine Unit, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (3)

  • 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.

    PMID: 32016427DERIVED

  • 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.

    PMID: 30649404DERIVED

  • 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.

    PMID: 30289507DERIVED

MeSH Terms

Conditions

Menstruation Disturbances

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Results Point of Contact

Title
Dr. Natalie Shaw
Organization
Massachusetts General Hospital
natalie.shaw@nih.gov

Study Officials

  • Janet Hall, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

June 24, 2015

First Posted

July 1, 2015

Study Start

April 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

December 24, 2018

Results First Posted

December 24, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)