CompletedNCT01121211Updated Sep 2, 2020Results posted

Hormonal Factors in the Treatment of Anorexia Nervosa

A Phase 2 interventional study of Testosterone and Placebo in Anorexia Nervosa, Eating Disorder and Anxiety, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-09-02.

Sponsored by Massachusetts General Hospital · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 90
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: Female

Study summary

The investigators are investigating whether a hormone that is naturally produced by the human body, called testosterone, can help improve weight, disordered eating, depression, and anxiety. The investigators hypothesize that testosterone will be a novel and effective endocrine-targeted therapy for patients with anorexia nervosa.

Conditions studied

Anorexia Nervosa
Eating Disorder
Anxiety
Depression

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Keywords

Testosterone
Hormones
Mental Health

In context

Anorexia

411 studies on the registry are indexed under Anorexia; 67 are open to participants now.

This study's enrollment of 90 is above the median of 41 across 287 interventional studies indexed under Anorexia.

Browse Anorexia studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: Female
Accepts healthy volunteers: No

Inclusion criteria

Age 18- 45 years; if participating in the neuroimaging sub study, age 18-40
Meet DSM-IV criteria for AN (restricting or binge/purge type, BMI 15-17.5) OR meet criteria for sub-threshold AN, i.e., all DSM-IV criteria except that patients can have a BMI of \<18.5 kg/m2 with or without amenorrhea.
Free T below the median for healthy women of reproductive age
All participants will be required to have a treatment team in place that consists of (at least) a primary care physician and a psychotherapist. Participants will need to have had regular contact with a primary care physician and be in an individual psychotherapy program. Participants will agree to continue with this treatment team and therapy throughout the active course of the study. If participants are taking psychotropic medications, the dose must be stable for 3 months before study entry

Exclusion criteria

Exclusion Criteria:

Pregnant women or women of child bearing potential who are not using medically accepted means of contraception (to include oral contraceptive, patch or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy).
Unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic
Serious suicide risk, substance use disorder active within last 6 months, bipolar I disorder, severe current depressive symptoms (indexed by HAM-D score >20 [excluding 2 eating/weight loss items related to the symptoms of AN]), or psychotic disorder
New psychotropic drug regimen, specifically a significant dose change or change in drug class, within the last 6 weeks. A study psychiatrist will assess whether PRN medications and dose changes are clinically significant enough to defer enrollment of specific potential study subjects.
Untreated hypothyroidism
If receiving estrogen therapy, including oral contraceptives or transdermal estrogen therapy, significant change in dose in the prior 3 months
Use of androgens or androgen precursors, including T, DHEA and methyl T, within 3 months
Any investigational psychotropic drug within the last 3 months
In the judgment of the study clinician, unlikely to be able to participate safely throughout the study period
Alanine aminotransferase (ALT) > 2x upper limit of normal
Creatinine >1.5x upper limit
Serum potassium \< lower limit of normal
If participating in the sub study, unable to tolerate 1 hour in MRI; contraindication to MRI (such as implanted pacemaker, cerebral aneurysm clips, extensive orthopedic hardware instrumentation); gastrointestinal tract surgery (including gastrectomy, gastric bypass surgery, and small or large bowel resection); history of psychosis by SCID

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 90 participants (actual)

Study arms

Active comparator
Testosterone
Testosterone x 24 weeks
Drug: Testosterone
Placebo comparator
Placebo
Placebo x 24 weeks
Drug: Placebo

Interventions

DrugTestosterone
Testosterone 300mcg transdermal patch x 24 weeks.
DrugPlacebo
Placebo transdermal patch x 24 weeks

What researchers measure

Primary outcomes

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

Results

Posted Apr 26, 2017

Participant flow

Participant flow — Overall Study
Milestone	Testosterone	Placebo
Started	43	47
Completed	32	35
Not completed	11	12

Outcome measures

PrimaryChange From Baseline in Weight

Weight in kilograms

Time frame:: Baseline, 24 Weeks
Reported as:: Mean · kilograms

Change From Baseline in Weight
kilograms	Testosterone	Placebo
Change From Baseline in Weight	0.1 ± 2.7	1.5 ± 3.2

PrimaryChange From Baseline in Depression Symptom Severity

Hamilton Depression Rating Scale (HAM-D) (Higher score = greater depression symptom severity; Score Range 0 - ≥ 23)

Time frame:: Baseline, 24 weeks
Reported as:: Mean · HAM-D score on a scale

Change From Baseline in Depression Symptom Severity
HAM-D score on a scale	Testosterone	Placebo
Change From Baseline in Depression Symptom Severity	-3 ± 5	-3 ± 5

Adverse events

Collected over 24 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Testosterone	0/43 (0%)	4/43 (9.3%)	33/43 (76.7%)
Placebo	0/47 (0%)	1/47 (2.1%)	33/47 (70.2%)

Most frequent serious events

Most frequent serious events
Event	Testosterone	Placebo
Hospitalization due to exacerbation of GI disordersGastrointestinal disorders	2/43	0/47
Hospitalization due to anorexia nervosaPsychiatric disorders	1/43	0/47
Hospitalization due to depression exacerbationPsychiatric disorders	1/43	1/47

Most frequent other events

Most frequent other events
Event	Testosterone	Placebo
Acne or Increase in acneSkin and subcutaneous tissue disorders	14/43	18/47
Patch site irritationSkin and subcutaneous tissue disorders	12/43	15/47
Hirsutism or Increased hair growthSkin and subcutaneous tissue disorders	9/43	10/47
DepilationSkin and subcutaneous tissue disorders	2/43	4/47
Oily skin or Increase in oily skinSkin and subcutaneous tissue disorders	3/43	2/47

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Testosterone	Placebo	Total
<=18 years	0	0	0
Between 18 and 65 years	43	47	90
>=65 years	0	0	0

Age, Continuous
Age, Continuous(years)	Testosterone	Placebo	Total
Mean	28 ± 7	27 ± 7	27 ± 7

Sex: Female, Male
Sex: Female, Male(Participants)	Testosterone	Placebo	Total
Female	43	47	90
Male	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	Testosterone	Placebo	Total
United States	43	47	90

Study locations

1 site

Massachusetts General Hospital
Boston, Massachusetts 02144, United States

References and documents

Publications

Kimball A, Schorr M, Meenaghan E, Bachmann KN, Eddy KT, Misra M, Lawson EA, Kreiger-Benson E, Herzog DB, Koman S, Keane RJ, Ebrahimi S, Schoenfeld D, Klibanski A, Miller KK. A Randomized Placebo-Controlled Trial of Low-Dose Testosterone Therapy in Women With Anorexia Nervosa. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4347-4355. doi: 10.1210/jc.2019-00828. PubMed 31219558 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01121211
Lead sponsor: Massachusetts General Hospital
Collaborators: National Institute of Mental Health (NIMH)
Responsible party: Karen Klahr Miller, MD (Chief, Neuroendocrine Unit, Massachusetts General Hospital) — Principal investigator
First posted: May 12, 2010
Start date: Apr 2010
Primary completion: Feb 2016
Completion: Feb 2016
Results posted: Apr 26, 2017
Last update: Sep 2, 2020

Study contacts

Anne Klibanski, MD

principal investigator · Massachusetts General Hospital

Karen K Miller, MD

study director · Massachusetts General Hospital

Erinne Meenaghan, NP

study chair · Massachusetts General Hospital

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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