Trial Outcomes & Findings for Hormonal Factors in the Treatment of Anorexia Nervosa (NCT NCT01121211)

Results Overview

Weight in kilograms

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

90 participants

Primary outcome timeframe

Baseline, 24 Weeks

Results posted on

2020-09-02

Participant Flow

Participant milestones

Participant milestones
Measure	Testosterone Testosterone x 24 weeks Testosterone: Testosterone 300mcg transdermal patch x 24 weeks.	Placebo Placebo x 24 weeks Placebo: Placebo transdermal patch x 24 weeks
Overall Study STARTED	43	47
Overall Study COMPLETED	32	35
Overall Study NOT COMPLETED	11	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hormonal Factors in the Treatment of Anorexia Nervosa

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Testosterone n=43 Participants Testosterone x 24 weeks Testosterone: Testosterone 300mcg transdermal patch x 24 weeks. Placebo: Placebo transdermal patch x 24 weeks	Placebo n=47 Participants Placebo x 24 weeks Testosterone: Testosterone 300mcg transdermal patch x 24 weeks. Placebo: Placebo transdermal patch x 24 weeks	Total n=90 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=99 Participants	47 Participants n=107 Participants	90 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	28 years STANDARD_DEVIATION 7 • n=99 Participants	27 years STANDARD_DEVIATION 7 • n=107 Participants	27 years STANDARD_DEVIATION 7 • n=206 Participants
Sex: Female, Male Female	43 Participants n=99 Participants	47 Participants n=107 Participants	90 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	43 Participants n=99 Participants	47 Participants n=107 Participants	90 Participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline, 24 Weeks

Population: All subjects who received at least one dose of study medication

Weight in kilograms

Outcome measures

Outcome measures
Measure	Testosterone n=42 Participants Testosterone x 24 weeks Testosterone: Testosterone 300mcg transdermal patch x 24 weeks. Placebo: Placebo transdermal patch x 24 weeks	Placebo n=46 Participants Placebo x 24 weeks Testosterone: Testosterone 300mcg transdermal patch x 24 weeks. Placebo: Placebo transdermal patch x 24 weeks
Change From Baseline in Weight	0.1 kilograms Standard Deviation 2.7	1.5 kilograms Standard Deviation 3.2

PRIMARY outcome

Timeframe: Baseline, 24 weeks

Population: All subjects who received at least one dose of study medication

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

Outcome measures

Outcome measures
Measure	Testosterone n=42 Participants Testosterone x 24 weeks Testosterone: Testosterone 300mcg transdermal patch x 24 weeks. Placebo: Placebo transdermal patch x 24 weeks	Placebo n=46 Participants Placebo x 24 weeks Testosterone: Testosterone 300mcg transdermal patch x 24 weeks. Placebo: Placebo transdermal patch x 24 weeks
Change From Baseline in Depression Symptom Severity	-3 HAM-D score on a scale Standard Deviation 5	-3 HAM-D score on a scale Standard Deviation 5

Adverse Events

Testosterone

Serious events: 4 serious events

Other events: 33 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Testosterone n=43 participants at risk Testosterone x 24 weeks Testosterone: Testosterone 300mcg transdermal patch x 24 weeks.	Placebo n=47 participants at risk Placebo x 24 weeks Placebo: Placebo transdermal patch x 24 weeks
Psychiatric disorders Hospitalization due to anorexia nervosa	2.3% 1/43 • Number of events 1 • 24 weeks	0.00% 0/47 • 24 weeks
Gastrointestinal disorders Hospitalization due to exacerbation of GI disorders	4.7% 2/43 • Number of events 2 • 24 weeks	0.00% 0/47 • 24 weeks
Psychiatric disorders Hospitalization due to depression exacerbation	2.3% 1/43 • Number of events 1 • 24 weeks	2.1% 1/47 • Number of events 1 • 24 weeks

Other adverse events

Other adverse events
Measure	Testosterone n=43 participants at risk Testosterone x 24 weeks Testosterone: Testosterone 300mcg transdermal patch x 24 weeks.	Placebo n=47 participants at risk Placebo x 24 weeks Placebo: Placebo transdermal patch x 24 weeks
Skin and subcutaneous tissue disorders Acne or Increase in acne	32.6% 14/43 • Number of events 24 • 24 weeks	38.3% 18/47 • Number of events 24 • 24 weeks
Skin and subcutaneous tissue disorders Patch site irritation	27.9% 12/43 • Number of events 12 • 24 weeks	31.9% 15/47 • Number of events 15 • 24 weeks
Skin and subcutaneous tissue disorders Oily skin or Increase in oily skin	7.0% 3/43 • Number of events 3 • 24 weeks	4.3% 2/47 • Number of events 3 • 24 weeks
Skin and subcutaneous tissue disorders Hirsutism or Increased hair growth	20.9% 9/43 • Number of events 15 • 24 weeks	21.3% 10/47 • Number of events 15 • 24 weeks
Skin and subcutaneous tissue disorders Depilation	4.7% 2/43 • Number of events 2 • 24 weeks	8.5% 4/47 • Number of events 5 • 24 weeks

Additional Information

Dr. Anne Klibanski

Massachusetts General Hospital

Phone: 6177263870

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place