CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 121 enrolled
Drug / intervention
Transdermal 17Beta-estradiol, progesterone +2 moredrug
Likely dose
Transdermal 17Beta-estradiol, progesterone 100 mcgfrom 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/NCT00946192
NCT00946192Phase 3Completed
CompareCT.gov

Fat Mediated Modulation of Reproductive and Endocrine Function in Young Athletes

Massachusetts General Hospital·interventional·Posted Jul 24, 2009·Updated Jun 11, 2021

In Brief

A Phase 3 clinical trial evaluating Transdermal 17Beta-estradiol, progesterone, Ethinyl Estradiol + Desogestrel, and 1 other intervention for Exercise-related Amenorrhea. Completed, enrolled 121 participants across 1 site.

Detailed Summary

One aim of this study is to determine changes in body composition and hormones that differentiate athletes who stop getting their periods versus those who continue to get their periods and non-athletes. The second aim of this study is to determine whether transdermal or oral estrogen (versus no estrogen) is effective in increasing bone density and improving bone microarchitecture in adolescent athletes who are not getting their periods and are thus estrogen deficient. The investigators hypothesize that transdermal estrogen will be more effective than oral estrogen or no estrogen in improving bone health in amenorrheic adolescent athletes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsExercise-related Amenorrhea
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 24, 2009
Enrollment StartMay 1, 2009
Primary CompletionFeb 1, 2020
Study CompletionApr 1, 2021
TodayJul 2, 2026
Enrollment to primary: 10.8 yearsPosted 16.9 years ago

Interventions

Transdermal 17Beta-estradiol, progesteronedrug

100 mcg/day 17Beta-estradiol; transdermal twice weekly application for 12 months (with cyclic micronized progesterone pills (Prometrium): 200 mg taken orally daily Day 1 to Day 12 each month) + Elemental calcium 1200 mg and Vit D 400 IU taken orally daily

Ethinyl Estradiol + Desogestreldrug

Oral ethinyl estradiol (0.03 mg) + desogestrel (0.15 mg) + Elemental calcium 1200 mg and Vit D 400 IU taken once daily

Sham Comparatordietary

Elemental calcium 1200 mg and Vit D 400 IU taken orally daily