CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 9 enrolled
Drug / intervention
micronized progesterone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02486757
NCT02486757Early Ph 1Completed

Investigation of Female Reproductive Hormone Dynamics During Adolescence

Massachusetts General Hospital·interventional·Posted Jul 1, 2015·Updated Dec 24, 2018

In Brief

A Early Phase 1 clinical trial evaluating micronized progesterone and transdermal estradiol for Menstruation Disturbances. Completed, enrolled 9 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 1, 2015
Enrollment StartApr 1, 2015
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.0 years ago

Interventions

micronized progesteronedrug

transdermal estradioldrug