Trial · NCT01121211

Hormonal Factors in the Treatment of Anorexia Nervosa

NCT01121211, Phase 2, Completed, Massachusetts General Hospital; results first posted 2017-04-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Hormonal Factors in the Treatment of Anorexia Nervosa. Trials, record NCT01121211. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01121211

On this page

Trial

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

Title: Hormonal Factors in the Treatment of Anorexia Nervosa
NCT number: NCT01121211
Status: Completed
Phases: Phase 2
Enrollment: 90 participants, actual
Lead sponsor: Massachusetts General Hospital
Conditions: Anorexia Nervosa, Eating Disorder, Anxiety, Depression
Interventions: Testosterone, Placebo
First posted: 2010-05-12
Last updated: 2020-09-02
Results first posted: 2017-04-26

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Weight	Baseline, 24 Weeks	Weight in kilograms
Primary	Change From Baseline in Depression Symptom Severity	Baseline, 24 weeks	Hamilton Depression Rating Scale (HAM-D) (Higher score = greater depression symptom severity; Score Range 0 - ≥ 23)

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 From Baseline in Weight	Baseline, 24 Weeks	All subjects who received at least one dose of study medication	kilograms	MEAN
PRIMARY	Change From Baseline in Depression Symptom Severity	Baseline, 24 weeks	All subjects who received at least one dose of study medication	HAM-D score on a scale	MEAN

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Spread	Units
Change From Baseline in Weight	Testosterone	0.1	Standard Deviation 2.7	kilograms
Change From Baseline in Weight	Placebo	1.5	Standard Deviation 3.2	kilograms
Change From Baseline in Depression Symptom Severity	Testosterone	-3	Standard Deviation 5	HAM-D score on a scale
Change From Baseline in Depression Symptom Severity	Placebo	-3	Standard Deviation 5	HAM-D score on a scale

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Testosterone	43
Overall Study	STARTED	Placebo	47
Overall Study	COMPLETED	Testosterone	32
Overall Study	COMPLETED	Placebo	35
Overall Study	NOT COMPLETED	Testosterone	11
Overall Study	NOT COMPLETED	Placebo	12

Source ClinicalTrials.gov

Adverse events16

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	Acne or Increase in acne	Skin and subcutaneous tissue disorders	Testosterone	14	43	24
other	Acne or Increase in acne	Skin and subcutaneous tissue disorders	Placebo	18	47	24
other	Patch site irritation	Skin and subcutaneous tissue disorders	Testosterone	12	43	12
other	Patch site irritation	Skin and subcutaneous tissue disorders	Placebo	15	47	15
other	Oily skin or Increase in oily skin	Skin and subcutaneous tissue disorders	Testosterone	3	43	3
other	Oily skin or Increase in oily skin	Skin and subcutaneous tissue disorders	Placebo	2	47	3
other	Hirsutism or Increased hair growth	Skin and subcutaneous tissue disorders	Testosterone	9	43	15
other	Hirsutism or Increased hair growth	Skin and subcutaneous tissue disorders	Placebo	10	47	15
other	Depilation	Skin and subcutaneous tissue disorders	Testosterone	2	43	2
other	Depilation	Skin and subcutaneous tissue disorders	Placebo	4	47	5

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Testosterone	0	43
Total, all-cause mortality	Placebo	0	47
Total, other adverse events	Testosterone	33	43
Total, other adverse events	Placebo	33	47
Total, serious adverse events	Testosterone	4	43
Total, serious adverse events	Placebo	1	47

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
31219558	DERIVED	PubMed
36798485	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
R01MH083657	Hormonal Factors in the Treatment of Anorexia Nervosa	KLIBANSKI, ANNE	MASSACHUSETTS GENERAL HOSPITAL	NATIONAL INSTITUTE OF MENTAL HEALTH	2010 to 2014

Source NIH RePORTER

Trial comparisons2

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

Comparison	Source
Testosterone vs Placebo: deaths from any cause	Trial comparisons
Testosterone vs Placebo: serious adverse events	Trial comparisons

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/NCT01121211

GET https://conductscience.org/api/trials/v1/NCT01121211/registered

API reference For AI assistants