drugset / Trial / NCT02486757

Investigation of Female Reproductive Hormone Dynamics During Adolescence

NCT02486757

Phase 0 Completed 9 enrolled Massachusetts General Hospital
NaSingle-groupOpen-labelBasic science

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.

Timeline

Start
2015-04
Primary completion
2016-03-01
Completion
2016-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Estradiol Other / unclassified 50 ug Other
Subject Progesterone Other / unclassified 0.5 mg/kg Oral

Indications