Trial Outcomes & Findings for Endometrial Safety Study of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women (NCT NCT00467259)

NCT ID: NCT00467259

Last Updated: 2011-12-15

Results Overview

Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1271 participants

Primary outcome timeframe

52 weeks

Results posted on

2011-12-15

Participant Flow

Screening began 14 May 2007

Randomized 1127 women not using concomitant estrogen \& progestin (E\&P) therapy. An additional 134 women using concomitant estrogen \& progestin therapy were randomized. Subjects were stratified by using or not using E\&P by site and then randomized 4:1 300 mcg/d TTS or placebo.

Participant milestones

Participant milestones
Measure	Placebo Placebo patch	Testosterone Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
Overall Study STARTED	251	1020
Overall Study ITT Population	251	1019
Overall Study COMPLETED	176	778
Overall Study NOT COMPLETED	75	242

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo patch	Testosterone Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
Overall Study Adverse Event	24	90
Overall Study Protocol Violation	1	7
Overall Study Withdrawal by Subject	34	108
Overall Study Physician Decision	0	2
Overall Study Lost to Follow-up	14	34
Overall Study Site Closed	2	1

Baseline Characteristics

Endometrial Safety Study of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=251 Participants Placebo patch	Testosterone n=1020 Participants Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks	Total n=1271 Participants Total of all reporting groups
Age Continuous	55.5 years STANDARD_DEVIATION 4.8 • n=5 Participants	55.8 years STANDARD_DEVIATION 4.9 • n=7 Participants	55.7 years STANDARD_DEVIATION 4.9 • n=5 Participants
Age, Customized 40-49 years old	21 Participants n=5 Participants	95 Participants n=7 Participants	116 Participants n=5 Participants
Age, Customized 50-59 years old	182 Participants n=5 Participants	700 Participants n=7 Participants	882 Participants n=5 Participants
Age, Customized 60-65 years old	39 Participants n=5 Participants	189 Participants n=7 Participants	228 Participants n=5 Participants
Age, Customized 66 + years old	9 Participants n=5 Participants	35 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Female	251 Participants n=5 Participants	1020 Participants n=7 Participants	1271 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	50 Participants n=7 Participants	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	237 Participants n=5 Participants	969 Participants n=7 Participants	1206 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Indian (American)	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian (Oriental)	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	9 Participants n=5 Participants	82 Participants n=7 Participants	91 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	231 Participants n=5 Participants	920 Participants n=7 Participants	1151 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Indian (Asian)	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Mexican	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Multi-Racial	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Hawaiian / Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Spanish	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	251 participants n=5 Participants	1020 participants n=7 Participants	1271 participants n=5 Participants

PRIMARY outcome

Timeframe: 52 weeks

Population: Subjects with evaluable endometrial biopsies.

Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies

Outcome measures

Outcome measures
Measure	Placebo n=137 Participants Placebo patch	Testosterone n=580 Participants Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD) Not Using Concomitant Estrogen and Progestin, Year 1	0 # Endometrial Hyperplasia/Evaluable Biop Interval 0.0 to 2.6	0 # Endometrial Hyperplasia/Evaluable Biop Interval 0.0 to 0.6

SECONDARY outcome

Timeframe: 52 weeks

Population: Subjects with evaluable endometrial biopsies.

Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Placebo patch	Testosterone n=68 Participants Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen and Progestin, Year 1	0 # Endometrial Hyperplasia/Evaluable Biop Interval 0.0 to 26.7	0 # Endometrial Hyperplasia/Evaluable Biop Interval 0.0 to 5.2

SECONDARY outcome

Timeframe: 52 weeks

Population: Subjects with evaluable endometrial biopsies.

Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies

Outcome measures

Outcome measures
Measure	Placebo n=147 Participants Placebo patch	Testosterone n=648 Participants Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
Incidence Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen & Progestin Combined With Those Not Using Estrogen & Progestin Therapy, Year 1	0 # Endometrial Hyperplasia/Evaluable Biop Interval 0.0 to 2.4	0 # Endometrial Hyperplasia/Evaluable Biop Interval 0.0 to 0.5

Adverse Events

Placebo

Serious events: 10 serious events

Other events: 125 other events

Deaths: 0 deaths

Testosterone

Serious events: 33 serious events

Other events: 472 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=251 participants at risk Placebo patch	Testosterone n=1019 participants at risk Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
Gastrointestinal disorders Diarrhoea	2.4% 6/251 • Number of events 6 • 52 week treatment period Vaginal bleeding that worsens from baseline will only be recorded on vaginal bleeding page, not as an AE. However, if vaginal bleeding results in study withdrawal or meets the ICH definition of a "serious" AE it will be recorded as an AE.	0.79% 8/1019 • Number of events 9 • 52 week treatment period Vaginal bleeding that worsens from baseline will only be recorded on vaginal bleeding page, not as an AE. However, if vaginal bleeding results in study withdrawal or meets the ICH definition of a "serious" AE it will be recorded as an AE.
Gastrointestinal disorders Nausea	2.0% 5/251 • Number of events 5 • 52 week treatment period Vaginal bleeding that worsens from baseline will only be recorded on vaginal bleeding page, not as an AE. However, if vaginal bleeding results in study withdrawal or meets the ICH definition of a "serious" AE it will be recorded as an AE.	0.98% 10/1019 • Number of events 11 • 52 week treatment period Vaginal bleeding that worsens from baseline will only be recorded on vaginal bleeding page, not as an AE. However, if vaginal bleeding results in study withdrawal or meets the ICH definition of a "serious" AE it will be recorded as an AE.
General disorders Application Site Reaction	18.7% 47/251 • Number of events 50 • 52 week treatment period Vaginal bleeding that worsens from baseline will only be recorded on vaginal bleeding page, not as an AE. However, if vaginal bleeding results in study withdrawal or meets the ICH definition of a "serious" AE it will be recorded as an AE.	17.7% 180/1019 • Number of events 196 • 52 week treatment period Vaginal bleeding that worsens from baseline will only be recorded on vaginal bleeding page, not as an AE. However, if vaginal bleeding results in study withdrawal or meets the ICH definition of a "serious" AE it will be recorded as an AE.
Infections and infestations Nasopharyngitis	4.4% 11/251 • Number of events 12 • 52 week treatment period Vaginal bleeding that worsens from baseline will only be recorded on vaginal bleeding page, not as an AE. However, if vaginal bleeding results in study withdrawal or meets the ICH definition of a "serious" AE it will be recorded as an AE.	2.2% 22/1019 • Number of events 26 • 52 week treatment period Vaginal bleeding that worsens from baseline will only be recorded on vaginal bleeding page, not as an AE. However, if vaginal bleeding results in study withdrawal or meets the ICH definition of a "serious" AE it will be recorded as an AE.
Infections and infestations Sinusitis	2.0% 5/251 • Number of events 5 • 52 week treatment period Vaginal bleeding that worsens from baseline will only be recorded on vaginal bleeding page, not as an AE. However, if vaginal bleeding results in study withdrawal or meets the ICH definition of a "serious" AE it will be recorded as an AE.	2.5% 25/1019 • Number of events 27 • 52 week treatment period Vaginal bleeding that worsens from baseline will only be recorded on vaginal bleeding page, not as an AE. However, if vaginal bleeding results in study withdrawal or meets the ICH definition of a "serious" AE it will be recorded as an AE.
Infections and infestations Upper Respiratory Tract Infection	4.0% 10/251 • Number of events 11 • 52 week treatment period Vaginal bleeding that worsens from baseline will only be recorded on vaginal bleeding page, not as an AE. However, if vaginal bleeding results in study withdrawal or meets the ICH definition of a "serious" AE it will be recorded as an AE.	2.7% 28/1019 • Number of events 32 • 52 week treatment period Vaginal bleeding that worsens from baseline will only be recorded on vaginal bleeding page, not as an AE. However, if vaginal bleeding results in study withdrawal or meets the ICH definition of a "serious" AE it will be recorded as an AE.
Infections and infestations Urinary Tract Infection	0.80% 2/251 • Number of events 2 • 52 week treatment period Vaginal bleeding that worsens from baseline will only be recorded on vaginal bleeding page, not as an AE. However, if vaginal bleeding results in study withdrawal or meets the ICH definition of a "serious" AE it will be recorded as an AE.	2.4% 24/1019 • Number of events 31 • 52 week treatment period Vaginal bleeding that worsens from baseline will only be recorded on vaginal bleeding page, not as an AE. However, if vaginal bleeding results in study withdrawal or meets the ICH definition of a "serious" AE it will be recorded as an AE.
Investigations Weight Increased	2.0% 5/251 • Number of events 5 • 52 week treatment period Vaginal bleeding that worsens from baseline will only be recorded on vaginal bleeding page, not as an AE. However, if vaginal bleeding results in study withdrawal or meets the ICH definition of a "serious" AE it will be recorded as an AE.	5.0% 51/1019 • Number of events 51 • 52 week treatment period Vaginal bleeding that worsens from baseline will only be recorded on vaginal bleeding page, not as an AE. However, if vaginal bleeding results in study withdrawal or meets the ICH definition of a "serious" AE it will be recorded as an AE.
Nervous system disorders Headache	3.2% 8/251 • Number of events 8 • 52 week treatment period Vaginal bleeding that worsens from baseline will only be recorded on vaginal bleeding page, not as an AE. However, if vaginal bleeding results in study withdrawal or meets the ICH definition of a "serious" AE it will be recorded as an AE.	2.2% 22/1019 • Number of events 26 • 52 week treatment period Vaginal bleeding that worsens from baseline will only be recorded on vaginal bleeding page, not as an AE. However, if vaginal bleeding results in study withdrawal or meets the ICH definition of a "serious" AE it will be recorded as an AE.
Psychiatric disorders Depression	3.6% 9/251 • Number of events 10 • 52 week treatment period Vaginal bleeding that worsens from baseline will only be recorded on vaginal bleeding page, not as an AE. However, if vaginal bleeding results in study withdrawal or meets the ICH definition of a "serious" AE it will be recorded as an AE.	1.3% 13/1019 • Number of events 14 • 52 week treatment period Vaginal bleeding that worsens from baseline will only be recorded on vaginal bleeding page, not as an AE. However, if vaginal bleeding results in study withdrawal or meets the ICH definition of a "serious" AE it will be recorded as an AE.
Skin and subcutaneous tissue disorders Hirsutism	1.6% 4/251 • Number of events 4 • 52 week treatment period Vaginal bleeding that worsens from baseline will only be recorded on vaginal bleeding page, not as an AE. However, if vaginal bleeding results in study withdrawal or meets the ICH definition of a "serious" AE it will be recorded as an AE.	4.0% 41/1019 • Number of events 48 • 52 week treatment period Vaginal bleeding that worsens from baseline will only be recorded on vaginal bleeding page, not as an AE. However, if vaginal bleeding results in study withdrawal or meets the ICH definition of a "serious" AE it will be recorded as an AE.
Vascular disorders Hot Flush	2.0% 5/251 • Number of events 5 • 52 week treatment period Vaginal bleeding that worsens from baseline will only be recorded on vaginal bleeding page, not as an AE. However, if vaginal bleeding results in study withdrawal or meets the ICH definition of a "serious" AE it will be recorded as an AE.	2.1% 21/1019 • Number of events 21 • 52 week treatment period Vaginal bleeding that worsens from baseline will only be recorded on vaginal bleeding page, not as an AE. However, if vaginal bleeding results in study withdrawal or meets the ICH definition of a "serious" AE it will be recorded as an AE.
Vascular disorders Hypertension	3.2% 8/251 • Number of events 8 • 52 week treatment period Vaginal bleeding that worsens from baseline will only be recorded on vaginal bleeding page, not as an AE. However, if vaginal bleeding results in study withdrawal or meets the ICH definition of a "serious" AE it will be recorded as an AE.	2.6% 27/1019 • Number of events 27 • 52 week treatment period Vaginal bleeding that worsens from baseline will only be recorded on vaginal bleeding page, not as an AE. However, if vaginal bleeding results in study withdrawal or meets the ICH definition of a "serious" AE it will be recorded as an AE.

Additional Information

Grexan Wulff, Manager Regulatory Affairs

Warner Chilcott

Phone: 973-442-3376

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60