Trial Outcomes & Findings for Assessing the Safety/Efficacy of Transdermal Testosterone in Female Patients With Symptomatic Heart Failure (NCT NCT00957034)
NCT ID: NCT00957034
Last Updated: 2012-01-13
Results Overview
Measurement of distance walked as fast as possible on a hard flat pathway in six minutes
TERMINATED
PHASE2
17 participants
Baseline and Day 180
2012-01-13
Participant Flow
6 month trial, screening started 22 Sep 2009 and ended 24 Mar 2010.
Participant milestones
| Measure |
Placebo
placebo patch
|
300 µg/Day Testosterone
300 micrograms/day transdermal testosterone patch
|
450 µg/Day Testosterone
450 micrograms/day transdermal testosterone patch
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
4
|
7
|
|
Overall Study
COMPLETED
|
0
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
6
|
Reasons for withdrawal
| Measure |
Placebo
placebo patch
|
300 µg/Day Testosterone
300 micrograms/day transdermal testosterone patch
|
450 µg/Day Testosterone
450 micrograms/day transdermal testosterone patch
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
|
Overall Study
Sponsor Terminated Study
|
6
|
1
|
5
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
Baseline Characteristics
Assessing the Safety/Efficacy of Transdermal Testosterone in Female Patients With Symptomatic Heart Failure
Baseline characteristics by cohort
| Measure |
Placebo
n=6 Participants
placebo patch
|
300 µg/Day Testosterone
n=4 Participants
300 micrograms/day transdermal testosterone patch
|
450 µg/Day Testosterone
n=7 Participants
450 micrograms/day transdermal testosterone patch
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
70.3 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
69.8 years
STANDARD_DEVIATION 5.0 • n=7 Participants
|
74.3 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
71.8 years
STANDARD_DEVIATION 7.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
17 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 180Population: No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim.
Measurement of distance walked as fast as possible on a hard flat pathway in six minutes
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Day 180Population: No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim.
Class I: Cardiac disease w/o limitation of physical activity. Class II: Cardiac disease resulting in slight limitation of physical activity. Comfortable at rest; ordinary activity results in fatigue, palpitation, dyspnea or anginal pain. Class III: Cardiac disease resulting in marked limitation of physical activity. Comfortable at rest; less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain. Class IV: Cardiac disease resulting in inability to carry on any physical activity w/o discomfort. Symptoms present at rest. Any physical activity increases discomfort.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Day 180Population: No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim.
Composite endpoint - patients who were hospitalized or died during the trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Day 180Population: No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim.
Minnesota Living with Heart Failure Questionnaire assessing how much heart failure affects life during previous month. Three scales measuring physical dimension (8 items, score 0-40), emotional dimension (5 items, score 0-25) and overall score (all 21 items, score 0-105). Eight separate items measure social \& economic impairments included as part of overall score.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Day 180Population: No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim.
Four global questions classifying improvement or deterioration in heart failure - Since your last clinic vist, has there been any change in activity limitation / symptoms / emotions / overall quality of life, related to your heart failure? Scale -7/very great deal worse, -6 great deal worse, -5 good deal worse, -4 moderately worse, -3 somewhat worse, -2 a little worse, -1 hardly any worse/almost the same, 0 no change, 1 hardly better/almost the same, 2 little better, 3 somewhat better, 4 moderately better, 5 good deal better, 6 great deal better, 7 very great deal better.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Day 180Population: No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim.
Physician rates improvement or deterioration in heart failure: Scale -7/very great deal worse, -6 great deal worse, -5 good deal worse, -4 moderately worse, -3 somewhat worse, -2 a little worse, -1 hardly any worse/almost the same, 0 no change, 1 hardly better/almost the same, 2 little better, 3 somewhat better, 4 moderately better, 5 good deal better, 6 great deal better, 7 very great deal better.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
300 µg/Day Testosterone
450 µg/Day Testosterone
Serious adverse events
| Measure |
Placebo
n=6 participants at risk
placebo patch
|
300 µg/Day Testosterone
n=4 participants at risk
300 micrograms/day transdermal testosterone patch
|
450 µg/Day Testosterone
n=7 participants at risk
450 micrograms/day transdermal testosterone patch
|
|---|---|---|---|
|
Cardiac disorders
Cardiac Failure Congestive
|
16.7%
1/6 • Number of events 1 • Six-month treatment period.
|
0.00%
0/4 • Six-month treatment period.
|
0.00%
0/7 • Six-month treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/6 • Six-month treatment period.
|
0.00%
0/4 • Six-month treatment period.
|
14.3%
1/7 • Number of events 1 • Six-month treatment period.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Six-month treatment period.
|
0.00%
0/4 • Six-month treatment period.
|
14.3%
1/7 • Number of events 1 • Six-month treatment period.
|
|
Infections and infestations
Gastroenteritis Viral
|
16.7%
1/6 • Number of events 1 • Six-month treatment period.
|
0.00%
0/4 • Six-month treatment period.
|
0.00%
0/7 • Six-month treatment period.
|
Other adverse events
| Measure |
Placebo
n=6 participants at risk
placebo patch
|
300 µg/Day Testosterone
n=4 participants at risk
300 micrograms/day transdermal testosterone patch
|
450 µg/Day Testosterone
n=7 participants at risk
450 micrograms/day transdermal testosterone patch
|
|---|---|---|---|
|
General disorders
Application Site Reaction
|
16.7%
1/6 • Number of events 1 • Six-month treatment period.
|
25.0%
1/4 • Number of events 1 • Six-month treatment period.
|
14.3%
1/7 • Number of events 1 • Six-month treatment period.
|
|
General disorders
Oedema Peripheral
|
16.7%
1/6 • Number of events 1 • Six-month treatment period.
|
0.00%
0/4 • Six-month treatment period.
|
0.00%
0/7 • Six-month treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/6 • Six-month treatment period.
|
25.0%
1/4 • Number of events 1 • Six-month treatment period.
|
0.00%
0/7 • Six-month treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/6 • Six-month treatment period.
|
0.00%
0/4 • Six-month treatment period.
|
14.3%
1/7 • Number of events 1 • Six-month treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/6 • Six-month treatment period.
|
0.00%
0/4 • Six-month treatment period.
|
14.3%
1/7 • Number of events 1 • Six-month treatment period.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/6 • Six-month treatment period.
|
0.00%
0/4 • Six-month treatment period.
|
14.3%
1/7 • Number of events 2 • Six-month treatment period.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/6 • Six-month treatment period.
|
0.00%
0/4 • Six-month treatment period.
|
14.3%
1/7 • Number of events 1 • Six-month treatment period.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/6 • Six-month treatment period.
|
0.00%
0/4 • Six-month treatment period.
|
14.3%
1/7 • Number of events 1 • Six-month treatment period.
|
|
Gastrointestinal disorders
Abdominal Pain
|
16.7%
1/6 • Number of events 1 • Six-month treatment period.
|
0.00%
0/4 • Six-month treatment period.
|
0.00%
0/7 • Six-month treatment period.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • Six-month treatment period.
|
0.00%
0/4 • Six-month treatment period.
|
0.00%
0/7 • Six-month treatment period.
|
|
Infections and infestations
Fungal Skin Infection
|
0.00%
0/6 • Six-month treatment period.
|
0.00%
0/4 • Six-month treatment period.
|
14.3%
1/7 • Number of events 1 • Six-month treatment period.
|
|
Infections and infestations
Bronchitis
|
16.7%
1/6 • Number of events 1 • Six-month treatment period.
|
0.00%
0/4 • Six-month treatment period.
|
0.00%
0/7 • Six-month treatment period.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Six-month treatment period.
|
0.00%
0/4 • Six-month treatment period.
|
14.3%
1/7 • Number of events 1 • Six-month treatment period.
|
|
Infections and infestations
Urinary Tract Infection
|
16.7%
1/6 • Number of events 1 • Six-month treatment period.
|
0.00%
0/4 • Six-month treatment period.
|
0.00%
0/7 • Six-month treatment period.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/6 • Six-month treatment period.
|
0.00%
0/4 • Six-month treatment period.
|
14.3%
1/7 • Number of events 1 • Six-month treatment period.
|
|
Injury, poisoning and procedural complications
Tendon Injury
|
16.7%
1/6 • Number of events 1 • Six-month treatment period.
|
0.00%
0/4 • Six-month treatment period.
|
0.00%
0/7 • Six-month treatment period.
|
|
Injury, poisoning and procedural complications
Contusion
|
16.7%
1/6 • Number of events 1 • Six-month treatment period.
|
0.00%
0/4 • Six-month treatment period.
|
14.3%
1/7 • Number of events 1 • Six-month treatment period.
|
|
Metabolism and nutrition disorders
Gout
|
16.7%
1/6 • Number of events 1 • Six-month treatment period.
|
0.00%
0/4 • Six-month treatment period.
|
0.00%
0/7 • Six-month treatment period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Number of events 1 • Six-month treatment period.
|
0.00%
0/4 • Six-month treatment period.
|
0.00%
0/7 • Six-month treatment period.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Six-month treatment period.
|
0.00%
0/4 • Six-month treatment period.
|
14.3%
1/7 • Number of events 1 • Six-month treatment period.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/6 • Six-month treatment period.
|
0.00%
0/4 • Six-month treatment period.
|
14.3%
1/7 • Number of events 1 • Six-month treatment period.
|
|
Reproductive system and breast disorders
Breast Mass
|
16.7%
1/6 • Number of events 1 • Six-month treatment period.
|
0.00%
0/4 • Six-month treatment period.
|
0.00%
0/7 • Six-month treatment period.
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.00%
0/6 • Six-month treatment period.
|
0.00%
0/4 • Six-month treatment period.
|
14.3%
1/7 • Number of events 1 • Six-month treatment period.
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • Number of events 1 • Six-month treatment period.
|
0.00%
0/4 • Six-month treatment period.
|
0.00%
0/7 • Six-month treatment period.
|
Additional Information
Grexan Wulff, Manager Regulatory Affairs
Warner Chilcott
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60