Trial Outcomes & Findings for Degarelix as Second-Line Hormonal Treatment After Prostate-specific Antigen (PSA)-Failure in GnRH Agonist Treated Patients With Prostate Cancer (NCT NCT00738673)
NCT ID: NCT00738673
Last Updated: 2013-01-18
Results Overview
Response to treatment was defined as: * Response (stabilisation or decrease): Difference ≤ +10% of Baseline level * No response (increase): Difference \> +10% of Baseline level
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
Day 0 (baseline), 3 months
Results posted on
2013-01-18
Participant Flow
Cohort 1 comprised a broad spectrum of biochemically relapsed participants (on castrate level) on long term hormonal treatment in different stages of the disease (primarily advance stages), however not in need of chemotherapy. The second cohort was similar, although testosterone levels were to be above castrate level (≥0.32 ng/mL).
Participant milestones
| Measure |
Degarelix - Cohort 1
Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
Degarelix - Cohort 2
Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
12
|
|
Overall Study
Intent to Treat Population
|
24
|
12
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
24
|
11
|
Reasons for withdrawal
| Measure |
Degarelix - Cohort 1
Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
Degarelix - Cohort 2
Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
19
|
8
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
Baseline Characteristics
Degarelix as Second-Line Hormonal Treatment After Prostate-specific Antigen (PSA)-Failure in GnRH Agonist Treated Patients With Prostate Cancer
Baseline characteristics by cohort
| Measure |
Degarelix - Cohort 1
n=24 Participants
Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
Degarelix - Cohort 2
n=12 Participants
Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
72.7 years
STANDARD_DEVIATION 9.11 • n=5 Participants
|
76.5 years
STANDARD_DEVIATION 4.68 • n=7 Participants
|
73.9 years
STANDARD_DEVIATION 8.08 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
24 participants
n=5 Participants
|
12 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
HIspanic or Latino
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
24 participants
n=5 Participants
|
12 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Weight
|
90.5 kg
STANDARD_DEVIATION 17.3 • n=5 Participants
|
87.6 kg
STANDARD_DEVIATION 11.0 • n=7 Participants
|
89.6 kg
STANDARD_DEVIATION 15.5 • n=5 Participants
|
|
Height
|
1.74 meters
STANDARD_DEVIATION 0.06 • n=5 Participants
|
1.72 meters
STANDARD_DEVIATION 0.05 • n=7 Participants
|
1.73 meters
STANDARD_DEVIATION 0.06 • n=5 Participants
|
|
Stage of Prostate Cancer at Diagnosis
Localized
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Stage of Prostate Cancer at Diagnosis
Locally advanced
|
11 participants
n=5 Participants
|
1 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Stage of Prostate Cancer at Diagnosis
Metastatic
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Stage of Prostate Cancer at Diagnosis
Not classifiable
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Stage of Prostate Cancer at Enrolment
Localized
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Stage of Prostate Cancer at Enrolment
Locally advanced
|
9 participants
n=5 Participants
|
0 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Stage of Prostate Cancer at Enrolment
Metastatic
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Stage of Prostate Cancer at Enrolment
Not classifiable
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Gleason Score
2-4
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Gleason Score
5-6
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Gleason Score
7-10
|
19 participants
n=5 Participants
|
7 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Eastern Cooporative Oncology Group (ECOG) Performance Status
Fully active
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Eastern Cooporative Oncology Group (ECOG) Performance Status
Restricted, but ambulatory
|
17 participants
n=5 Participants
|
11 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Eastern Cooporative Oncology Group (ECOG) Performance Status
Ambulatory, unable to work
|
7 participants
n=5 Participants
|
1 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Eastern Cooporative Oncology Group (ECOG) Performance Status
Capable of only limited selfcare
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Eastern Cooporative Oncology Group (ECOG) Performance Status
Completely disabled
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 (baseline), 3 monthsPopulation: Intent to treat population. Last observation carried forward.
Response to treatment was defined as: * Response (stabilisation or decrease): Difference ≤ +10% of Baseline level * No response (increase): Difference \> +10% of Baseline level
Outcome measures
| Measure |
Degarelix - Cohort 1
n=24 Participants
Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
Degarelix - Cohort 2
n=12 Participants
Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
|---|---|---|
|
Participants' Response in Prostate-Specific Antigen (PSA) Level at Three Months As Compared to Baseline
Response
|
16.67 percentage of participants
Interval 4.74 to 37.38
|
33.33 percentage of participants
Interval 9.92 to 65.11
|
|
Participants' Response in Prostate-Specific Antigen (PSA) Level at Three Months As Compared to Baseline
No Response
|
83.33 percentage of participants
Interval 62.62 to 95.26
|
66.67 percentage of participants
Interval 34.89 to 90.08
|
SECONDARY outcome
Timeframe: Day 0 (baseline), 1 monthPopulation: Full analysis set of participants with baseline and month 1 values. Per protocol, the one month timeframe was only analyzed for cohort 2.
Response to treatment was defined as: * Response (stabilisation or decrease): Difference ≤ +10% of Baseline level * No response (increase): Difference \> +10% of Baseline level. Per protocol, the one month timeframe was only analyzed for cohort 2.
Outcome measures
| Measure |
Degarelix - Cohort 1
Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
Degarelix - Cohort 2
n=9 Participants
Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
|---|---|---|
|
Participants' Response in Prostate-Specific Antigen (PSA) Level at One Month As Compared to Baseline
Response
|
—
|
66.67 percentage of participants
Interval 29.93 to 92.51
|
|
Participants' Response in Prostate-Specific Antigen (PSA) Level at One Month As Compared to Baseline
No Response
|
—
|
33.33 percentage of participants
Interval 7.49 to 70.07
|
SECONDARY outcome
Timeframe: Day 0 (baseline), 2 monthsPopulation: Full analysis set of participants with baseline and month 2 values. Per protocol, the two month timeframe was only analyzed for cohort 2.
Response to treatment was defined as: * Response (stabilisation or decrease): Difference ≤ +10% of Baseline level * No response (increase): Difference \> +10% of Baseline level. Per protocol, the two month timeframe was only analyzed for cohort 2.
Outcome measures
| Measure |
Degarelix - Cohort 1
Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
Degarelix - Cohort 2
n=10 Participants
Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
|---|---|---|
|
Participants' Response in Prostate-Specific Antigen (PSA) Level at Two Months As Compared to Baseline
Response
|
—
|
40.00 percentage of participants
Interval 12.16 to 73.76
|
|
Participants' Response in Prostate-Specific Antigen (PSA) Level at Two Months As Compared to Baseline
No Response
|
—
|
60.00 percentage of participants
Interval 26.24 to 87.84
|
SECONDARY outcome
Timeframe: up to month 12Population: Intent to treat population
Participants who had no post-baseline serum testosterone level above castrate level which was \<=0.5 ng/mL.
Outcome measures
| Measure |
Degarelix - Cohort 1
n=24 Participants
Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
Degarelix - Cohort 2
n=12 Participants
Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
|---|---|---|
|
Participants at Testosterone Castrate Level Throughout the Study
|
24 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Day 0 (baseline), up to month 12 (last visit)Population: Intent to treat population with a baseline and at least one scheduled post-baseline measurement.
Outcome measures
| Measure |
Degarelix - Cohort 1
n=24 Participants
Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
Degarelix - Cohort 2
n=9 Participants
Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
|---|---|---|
|
Change From Baseline in Serum Levels of Testosterone at the Last Visit
|
-0.039 ng/mL
Standard Deviation 0.175
|
-0.038 ng/mL
Standard Deviation 0.631
|
SECONDARY outcome
Timeframe: Day 0 (baseline), up to month 12 (last visit)Population: Intent to treat population with a baseline and at least one scheduled post-baseline measurement.
Outcome measures
| Measure |
Degarelix - Cohort 1
n=24 Participants
Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
Degarelix - Cohort 2
n=9 Participants
Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
|---|---|---|
|
Change From Baseline in Serum Levels of Prostate-Specific Antigen (PSA) at Last Visit
|
18 ng/mL
Standard Deviation 29
|
54 ng/mL
Standard Deviation 116
|
SECONDARY outcome
Timeframe: Day 0 (baseline), up to month 12 (last visit)Population: Intent to treat population with a baseline and at least one scheduled post-baseline measurement.
LH is measured in IU/L
Outcome measures
| Measure |
Degarelix - Cohort 1
n=24 Participants
Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
Degarelix - Cohort 2
n=9 Participants
Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
|---|---|---|
|
Percent Change From Baseline in Serum Levels of Luteinising Hormone (LH) at the Last Visit
|
58 percentage of baseline
Standard Deviation 286
|
123 percentage of baseline
Standard Deviation 277
|
SECONDARY outcome
Timeframe: Day 0 (baseline), up to month 12 (last visit)Population: Intent to treat population with a baseline and at least one scheduled post-baseline measurement.
Outcome measures
| Measure |
Degarelix - Cohort 1
n=24 Participants
Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
Degarelix - Cohort 2
n=9 Participants
Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
|---|---|---|
|
Change From Baseline in Serum Levels of Follicle-Stimulating Hormone (FSH) at the Last Visit
|
-1.64 IU/L
Standard Deviation 3.01
|
-2.01 IU/L
Standard Deviation 1.72
|
SECONDARY outcome
Timeframe: up to month 12Population: Full analysis set. Per the protocol, this analysis was only performed on Cohort 2.
Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.2 ng/mL.
Outcome measures
| Measure |
Degarelix - Cohort 1
Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
Degarelix - Cohort 2
n=12 Participants
Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
|---|---|---|
|
Participants at Testosterone Level <=0.2 ng/mL Throughout the Study
|
—
|
8 participants
|
SECONDARY outcome
Timeframe: up to month 12Population: Full analysis set. Per the protocol, this analysis was only performed on Cohort 2.
Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.32 ng/mL
Outcome measures
| Measure |
Degarelix - Cohort 1
Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
Degarelix - Cohort 2
n=12 Participants
Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
|---|---|---|
|
Participants at Testosterone Level <=0.32 ng/mL Throughout the Study
|
—
|
9 participants
|
SECONDARY outcome
Timeframe: up to month 12Population: Intent to treat population
Counts of participants who had PSA progression during the study. PSA progression was defined as PSA \>+10% of baseline value.
Outcome measures
| Measure |
Degarelix - Cohort 1
n=24 Participants
Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
Degarelix - Cohort 2
n=12 Participants
Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
|---|---|---|
|
Participants With Prostate-Specific Antigen (PSA) Progression Throughout the Study
|
21 participants
|
11 participants
|
SECONDARY outcome
Timeframe: up to month 12Population: Intent to treat population. Analysis was not performed since no participants died during study.
The overall survival time was defined as number of days from first treatment dose to date of death. If a patient did not die then the patient's data were censored at the date of last visit.
Outcome measures
Outcome data not reported
Adverse Events
Degarelix - Cohort 1
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Degarelix - Cohort 2
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Degarelix - Cohort 1
n=25 participants at risk
Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
Degarelix - Cohort 2
n=12 participants at risk
Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
4.0%
1/25 • up to month 13
|
0.00%
0/12 • up to month 13
|
|
Nervous system disorders
Carotid artery stenosis
|
4.0%
1/25 • up to month 13
|
0.00%
0/12 • up to month 13
|
|
Renal and urinary disorders
Bladder tamponade
|
4.0%
1/25 • up to month 13
|
0.00%
0/12 • up to month 13
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.00%
0/25 • up to month 13
|
8.3%
1/12 • up to month 13
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/25 • up to month 13
|
8.3%
1/12 • up to month 13
|
Other adverse events
| Measure |
Degarelix - Cohort 1
n=25 participants at risk
Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
Degarelix - Cohort 2
n=12 participants at risk
Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/25 • up to month 13
|
8.3%
1/12 • up to month 13
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/25 • up to month 13
|
8.3%
1/12 • up to month 13
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/25 • up to month 13
|
8.3%
1/12 • up to month 13
|
|
General disorders
Injection site erythema
|
40.0%
10/25 • up to month 13
|
50.0%
6/12 • up to month 13
|
|
General disorders
Injection site swelling
|
32.0%
8/25 • up to month 13
|
41.7%
5/12 • up to month 13
|
|
General disorders
Injection site pain
|
12.0%
3/25 • up to month 13
|
0.00%
0/12 • up to month 13
|
|
General disorders
Injection site induration
|
8.0%
2/25 • up to month 13
|
0.00%
0/12 • up to month 13
|
|
General disorders
General physical health deterioration
|
0.00%
0/25 • up to month 13
|
8.3%
1/12 • up to month 13
|
|
General disorders
Pyrexia
|
0.00%
0/25 • up to month 13
|
8.3%
1/12 • up to month 13
|
|
Infections and infestations
Urinary tract infection
|
4.0%
1/25 • up to month 13
|
8.3%
1/12 • up to month 13
|
|
Infections and infestations
Bronchitis
|
0.00%
0/25 • up to month 13
|
8.3%
1/12 • up to month 13
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/25 • up to month 13
|
8.3%
1/12 • up to month 13
|
|
Infections and infestations
Rhinitis
|
0.00%
0/25 • up to month 13
|
8.3%
1/12 • up to month 13
|
|
Investigations
Weight increase
|
0.00%
0/25 • up to month 13
|
8.3%
1/12 • up to month 13
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/25 • up to month 13
|
8.3%
1/12 • up to month 13
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/25 • up to month 13
|
8.3%
1/12 • up to month 13
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/25 • up to month 13
|
8.3%
1/12 • up to month 13
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/25 • up to month 13
|
8.3%
1/12 • up to month 13
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/25 • up to month 13
|
8.3%
1/12 • up to month 13
|
|
Vascular disorders
Hot flush
|
8.0%
2/25 • up to month 13
|
0.00%
0/12 • up to month 13
|
|
Vascular disorders
Venous stasis
|
0.00%
0/25 • up to month 13
|
8.3%
1/12 • up to month 13
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
- Publication restrictions are in place
Restriction type: OTHER