Trial Outcomes & Findings for Effects of Testosterone in Women With Depression (NCT NCT00676676)

Results Overview

the MADRS is a diagnostic questionnaire that is used to measure the severity of depressive episodes in patients with mood disorders. The minimum and maximum values are 0 and 60 respectively (higher scores are more severe).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

Baseline, 2-week, 8-week

Results posted on

2012-11-30

Participant Flow

Participant milestones

Participant milestones
Measure	Testosterone Testosterone Patch 300mcg replaced every 3-4 days
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Testosterone in Women With Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Testosterone n=9 Participants Testosterone Patch 300mcg replaced every 3-4 days
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age Continuous	48.1 years STANDARD_DEVIATION 12.2 • n=93 Participants
Sex: Female, Male Female	9 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Region of Enrollment United States	9 participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline, 2-week, 8-week

Population: This was a pilot protocol

the MADRS is a diagnostic questionnaire that is used to measure the severity of depressive episodes in patients with mood disorders. The minimum and maximum values are 0 and 60 respectively (higher scores are more severe).

Outcome measures

Outcome measures
Measure	Testosterone n=9 Participants Testosterone Patch 300mcg replaced every 3-4 days
Montgomery-Asberg Depression Rating Scale (MADRS) Scale Baseline visit	25.9 units on a scale Standard Deviation 4.6
Montgomery-Asberg Depression Rating Scale (MADRS) Scale 2-week visit	14.7 units on a scale Standard Deviation 8.4
Montgomery-Asberg Depression Rating Scale (MADRS) Scale 8-week visit	15.2 units on a scale Standard Deviation 10.9

Adverse Events

Testosterone

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Testosterone n=9 participants at risk Testosterone Patch 300mcg replaced every 3-4 days
Skin and subcutaneous tissue disorders erythema at testosterone patch site	11.1% 1/9 • Number of events 1 • 8-weeks
Skin and subcutaneous tissue disorders oily skin/acne	11.1% 1/9 • Number of events 1 • 8-weeks

Additional Information

Dr. Karen K. Miller

Massachusetts General Hospita

Phone: 617-726-3870

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place