Trial · NCT00946192

Fat Mediated Modulation of Reproductive and Endocrine Function in Young Athletes

NCT00946192, Phase 3, Completed, Massachusetts General Hospital; results first posted 2020-03-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Fat Mediated Modulation of Reproductive and Endocrine Function in Young Athletes. Trials, record NCT00946192. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00946192

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Fat Mediated Modulation of Reproductive and Endocrine Function in Young Athletes
NCT number: NCT00946192
Status: Completed
Phases: Phase 3
Enrollment: 121 participants, actual
Lead sponsor: Massachusetts General Hospital
Conditions: Exercise-related Amenorrhea
Interventions: Transdermal 17Beta-estradiol, progesterone, Ethinyl Estradiol + Desogestrel, Sham Comparator
First posted: 2009-07-24
Last updated: 2021-06-11
Results first posted: 2020-03-18

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Lumbar Bone Mineral Density	12 months	Change in bone density with transdermal estrogen versus oral estrogen or no estrogen in amenorrheic athletes
Secondary	Change in Total Volumetric Bone Mineral Density (Tibia)	12 months	Change in total volumetric bone density at the tibia with transdermal estrogen versus oral estrogen or no estrogen in amenorrheic athletes

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Lumbar Bone Mineral Density	12 months		g/cm^2	MEAN
SECONDARY	Change in Total Volumetric Bone Mineral Density (Tibia)	12 months		mg HA/cm^3	MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Lumbar Bone Mineral Density	Estrogen Patch	0.025	Standard Error 0.011	g/cm^2
Change in Lumbar Bone Mineral Density	Estrogen Pill	0.008	Standard Error 0.011	g/cm^2
Change in Lumbar Bone Mineral Density	Control	0.012	Standard Error 0.012	g/cm^2
Change in Total Volumetric Bone Mineral Density (Tibia)	Estrogen Patch	7.01	Standard Error 3.06	mg HA/cm^3
Change in Total Volumetric Bone Mineral Density (Tibia)	Estrogen Pill	1.17	Standard Error 3.05	mg HA/cm^3
Change in Total Volumetric Bone Mineral Density (Tibia)	Control	3.71	Standard Error 4.44	mg HA/cm^3

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Estrogen Patch	43
Overall Study	STARTED	Estrogen Pill	40
Overall Study	STARTED	Control	38
Overall Study	COMPLETED	Estrogen Patch	25
Overall Study	COMPLETED	Estrogen Pill	22
Overall Study	COMPLETED	Control	26
Overall Study	NOT COMPLETED	Estrogen Patch	18
Overall Study	NOT COMPLETED	Estrogen Pill	18
Overall Study	NOT COMPLETED	Control	12

Source ClinicalTrials.gov

Adverse events69

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headache	Nervous system disorders	Estrogen Patch	2	43	2
other	Headache	Nervous system disorders	Estrogen Pill	1	40	1
other	Headache	Nervous system disorders	Control	0	38	0
other	Dizziness	Vascular disorders	Estrogen Patch	1	43	1
other	Dizziness	Vascular disorders	Estrogen Pill	0	40	0
other	Dizziness	Vascular disorders	Control	0	38	0
other	Nausea	Gastrointestinal disorders	Estrogen Patch	0	43	0
other	Nausea	Gastrointestinal disorders	Estrogen Pill	2	40	2
other	Nausea	Gastrointestinal disorders	Control	0	38	0
other	Fatigue	General disorders	Estrogen Patch	0	43	0

1 to 10 of 69Source ClinicalTrials.gov

See all 69 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Estrogen Patch	0	43
Total, all-cause mortality	Estrogen Pill	0	40
Total, all-cause mortality	Control	0	38
Total, other adverse events	Estrogen Patch	10	43
Total, other adverse events	Estrogen Pill	13	40
Total, other adverse events	Control	1	38
Total, serious adverse events	Estrogen Patch	3	43
Total, serious adverse events	Estrogen Pill	0	40
Total, serious adverse events	Control	1	38

Source ClinicalTrials.gov

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21816790	DERIVED	PubMed
22252944	DERIVED	PubMed
28297591	DERIVED	PubMed
30301734	DERIVED	PubMed
30476179	DERIVED	PubMed
30639922	DERIVED	PubMed
31603998	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01HD060827	Fat Mediated Modulation of Reproductive and Endocrine Function in Young Athletes	MISRA, MADHUSMITA	MASSACHUSETTS GENERAL HOSPITAL	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2009 to 2013

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00946192

GET https://conductscience.org/api/trials/v1/NCT00946192/events?page=2

API reference For AI assistants