Trial Outcomes & Findings for Adrenal and Gonadal Hormone Replacement in Anorexia Nervosa (NCT NCT00310791)

Last Updated: 2018-04-11

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

80 participants

Primary outcome timeframe

18-Months

Results posted on

2018-04-11

Withdrawal data not reported

Adrenal and Gonadal Hormone Replacement in Anorexia Nervosa

Baseline characteristics by cohort
Measure	Placebo n=40 Participants	Active n=40 Participants	Total n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=5 Participants	39 Participants n=7 Participants	76 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	21 years STANDARD_DEVIATION 4 • n=5 Participants	24 years STANDARD_DEVIATION 6 • n=7 Participants	22 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants	40 participants n=7 Participants	80 participants n=5 Participants

Timeframe: 18-Months

Outcome measures
Measure	Placebo n=30 Participants Sugar Pill	Active n=31 Participants DHEA+HRT
Areal Bone Density by DXA	0.88 g/cm2 Standard Deviation 0.10	0.89 g/cm2 Standard Deviation 0.10

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Children's Hospital Boston

Phone: 401-444-4712