Trial Outcomes & Findings for Low Dose Tamoxifen for Mammographic Density Reduction (NCT NCT03346200)
NCT ID: NCT03346200
Last Updated: 2025-03-07
Results Overview
Change in mammography density. In particular, we will test for noninferiority in the proportion of women in the intervention arms (placebo, 1 mg, 2.5 mg, 5 mg, 10 mg) who have a density reduction as great as or greater (after 6 months) than the median density reduction in the 20 mg arm.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1440 participants
Primary outcome timeframe
6 months treatment
Results posted on
2025-03-07
Participant Flow
Participant milestones
| Measure |
20 mg Tamoxifen
Tamoxifen Oral Tablet: Randomised dose of tamoxifen 1 pill/day for 180 days
|
10 mg Tamoxifen
Tamoxifen Oral Tablet: Randomised dose of tamoxifen 1 pill/day for 180 days
|
5 mg Tamoxifen
Tamoxifen Oral Tablet: Randomised dose of tamoxifen 1 pill/day for 180 days
|
2.5 mg Tamoxifen
Tamoxifen Oral Tablet: Randomised dose of tamoxifen 1 pill/day for 180 days
|
1 mg Tamoxifen
Tamoxifen Oral Tablet: Randomised dose of tamoxifen 1 pill/day for 180 days
|
0 mg Tamoxifen
Placebo Oral Tablet: Randomised dose of tamoxifen 1 pill/day for 180 days
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
241
|
243
|
240
|
235
|
239
|
242
|
|
Overall Study
COMPLETED
|
171
|
167
|
157
|
159
|
174
|
183
|
|
Overall Study
NOT COMPLETED
|
70
|
76
|
83
|
76
|
65
|
59
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
20 mg Tamoxifen
n=241 Participants
Tamoxifen Oral Tablet: Randomised dose of tamoxifen 1 pill/day for 180 days
|
10 mg Tamoxifen
n=243 Participants
Tamoxifen Oral Tablet: Randomised dose of tamoxifen 1 pill/day for 180 days
|
5 mg Tamoxifen
n=240 Participants
Tamoxifen Oral Tablet: Randomised dose of tamoxifen 1 pill/day for 180 days
|
2.5 mg Tamoxifen
n=235 Participants
Tamoxifen Oral Tablet: Randomised dose of tamoxifen 1 pill/day for 180 days
|
1 mg Tamoxifen
n=239 Participants
Tamoxifen Oral Tablet: Randomised dose of tamoxifen 1 pill/day for 180 days
|
0 mg Tamoxifen
n=242 Participants
Placebo Oral Tablet: Randomised dose of tamoxifen 1 pill/day for 180 days
|
Total
n=1440 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=241 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=240 Participants
|
0 Participants
n=235 Participants
|
0 Participants
n=239 Participants
|
0 Participants
n=242 Participants
|
0 Participants
n=1440 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
181 Participants
n=241 Participants
|
179 Participants
n=243 Participants
|
185 Participants
n=240 Participants
|
181 Participants
n=235 Participants
|
193 Participants
n=239 Participants
|
177 Participants
n=242 Participants
|
1096 Participants
n=1440 Participants
|
|
Age, Categorical
>=65 years
|
60 Participants
n=241 Participants
|
64 Participants
n=243 Participants
|
55 Participants
n=240 Participants
|
54 Participants
n=235 Participants
|
46 Participants
n=239 Participants
|
65 Participants
n=242 Participants
|
344 Participants
n=1440 Participants
|
|
Age, Continuous
|
55.6 years
STANDARD_DEVIATION 9.5 • n=241 Participants
|
55.8 years
STANDARD_DEVIATION 10.0 • n=243 Participants
|
55.1 years
STANDARD_DEVIATION 9.7 • n=240 Participants
|
54.9 years
STANDARD_DEVIATION 9.7 • n=235 Participants
|
54.3 years
STANDARD_DEVIATION 9.4 • n=239 Participants
|
60.0 years
STANDARD_DEVIATION 9.9 • n=242 Participants
|
55.3 years
STANDARD_DEVIATION 9.7 • n=1440 Participants
|
|
Sex: Female, Male
Female
|
241 Participants
n=241 Participants
|
243 Participants
n=243 Participants
|
240 Participants
n=240 Participants
|
235 Participants
n=235 Participants
|
239 Participants
n=239 Participants
|
242 Participants
n=242 Participants
|
1440 Participants
n=1440 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=241 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=240 Participants
|
0 Participants
n=235 Participants
|
0 Participants
n=239 Participants
|
0 Participants
n=242 Participants
|
0 Participants
n=1440 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 6 months treatmentChange in mammography density. In particular, we will test for noninferiority in the proportion of women in the intervention arms (placebo, 1 mg, 2.5 mg, 5 mg, 10 mg) who have a density reduction as great as or greater (after 6 months) than the median density reduction in the 20 mg arm.
Outcome measures
| Measure |
20 mg Tamoxifen
n=203 Participants
Randomised dose of tamoxifen 1 pill/day for 180 days. Primary outcome: Change in mammography density in relation to 20 mg (non-inferiority)
|
10 mg Tamoxifen
n=210 Participants
Randomised dose of tamoxifen 1 pill/day for 180 days. Primary outcome: Change in mammography density in relation to 20 mg (non-inferiority)
|
5 mg Tamoxifen
n=201 Participants
Randomised dose of tamoxifen 1 pill/day for 180 days. Primary outcome: Change in mammography density in relation to 20 mg (non-inferiority)
|
2.5 mg Tamoxifen
n=200 Participants
Randomised dose of tamoxifen 1 pill/day for 180 days. Primary outcome: Change in mammography density in relation to 20 mg (non-inferiority)
|
1 mg Tamoxifen
n=205 Participants
Randomised dose of tamoxifen 1 pill/day for 180 days.Primary outcome: Change in mammography density in relation to 20 mg (non-inferiority)
|
0 mg Tamoxifen
n=211 Participants
Randomised dose of tamoxifen 1 pill/day for 180 days. Primary outcome: Change in mammography density in relation to 20 mg (non-inferiority)
|
|---|---|---|---|---|---|---|
|
Mammograpic Density Change
|
-9.6 Percentage of change
Interval -14.8 to -4.5
|
-6.8 Percentage of change
Interval -11.8 to -1.7
|
-1.0 Percentage of change
Interval -6.2 to 4.1
|
-6.9 Percentage of change
Interval -12.1 to -1.8
|
-1.0 Percentage of change
Interval -6.1 to 4.1
|
0.1 Percentage of change
Interval -4.9 to 5.1
|
SECONDARY outcome
Timeframe: From baseline (7-1days before first tablet) up to 6 months or day of discontionuation (prior to 6 months)Population: In all 1175 women, whereof 454 (39%) premenopausal and 721 (61%) postmenopausal, constitute the per protocol population which fulfilled teh 48-item Symptom questionnaire at Baseline and at End of treatment (6month or at time of Early termination)
Assess the level of side effects in the intervention arms compared to the 20 mg arm. Symptoms are reported on a 5-graded Likert score scale in a 48-item symptom questionnaire at Baseline and at End of treatment ( End of treatment= full-filled the 6 month treatment or at time of discontinuation prior to 6 months). The outcome measure is based on the sum in Likert score of five symptoms ('hot flashes', 'cold sweats', 'night sweats', 'vaginal discharge' and 'muscle cramps') which were found to have a significant change from start to the end of treatment in both pre- and postmenopausal women when contrasting the effect of 20 mg tamoxifen compared to women on placebo. The maximum/minimum range of change per symtom is 4 steps increase or decrease. Accordingly, in the Top-5 symtoms the maximum/minimum range is +/- 20. Higher scores mean a worse outcome.
Outcome measures
| Measure |
20 mg Tamoxifen
n=199 Participants
Randomised dose of tamoxifen 1 pill/day for 180 days. Primary outcome: Change in mammography density in relation to 20 mg (non-inferiority)
|
10 mg Tamoxifen
n=199 Participants
Randomised dose of tamoxifen 1 pill/day for 180 days. Primary outcome: Change in mammography density in relation to 20 mg (non-inferiority)
|
5 mg Tamoxifen
n=188 Participants
Randomised dose of tamoxifen 1 pill/day for 180 days. Primary outcome: Change in mammography density in relation to 20 mg (non-inferiority)
|
2.5 mg Tamoxifen
n=194 Participants
Randomised dose of tamoxifen 1 pill/day for 180 days. Primary outcome: Change in mammography density in relation to 20 mg (non-inferiority)
|
1 mg Tamoxifen
n=193 Participants
Randomised dose of tamoxifen 1 pill/day for 180 days.Primary outcome: Change in mammography density in relation to 20 mg (non-inferiority)
|
0 mg Tamoxifen
n=202 Participants
Randomised dose of tamoxifen 1 pill/day for 180 days. Primary outcome: Change in mammography density in relation to 20 mg (non-inferiority)
|
|---|---|---|---|---|---|---|
|
Level of Side Effects
|
2.71 Likert score change in Top5 Symptoms
Interval 2.29 to 3.13
|
2.97 Likert score change in Top5 Symptoms
Interval 2.5 to 3.45
|
2.52 Likert score change in Top5 Symptoms
Interval 2.07 to 2.97
|
2.39 Likert score change in Top5 Symptoms
Interval 1.94 to 2.85
|
1.65 Likert score change in Top5 Symptoms
Interval 1.24 to 2.06
|
0.36 Likert score change in Top5 Symptoms
Interval 0.32 to 0.68
|
SECONDARY outcome
Timeframe: From initiation of treatment (first tablet) up to 6 months of planned treatment (last tablet)Population: ITT population
Assess the level of drop out in the intervention arms compared to the 20 mg arm
Outcome measures
| Measure |
20 mg Tamoxifen
n=241 Participants
Randomised dose of tamoxifen 1 pill/day for 180 days. Primary outcome: Change in mammography density in relation to 20 mg (non-inferiority)
|
10 mg Tamoxifen
n=242 Participants
Randomised dose of tamoxifen 1 pill/day for 180 days. Primary outcome: Change in mammography density in relation to 20 mg (non-inferiority)
|
5 mg Tamoxifen
n=240 Participants
Randomised dose of tamoxifen 1 pill/day for 180 days. Primary outcome: Change in mammography density in relation to 20 mg (non-inferiority)
|
2.5 mg Tamoxifen
n=235 Participants
Randomised dose of tamoxifen 1 pill/day for 180 days. Primary outcome: Change in mammography density in relation to 20 mg (non-inferiority)
|
1 mg Tamoxifen
n=239 Participants
Randomised dose of tamoxifen 1 pill/day for 180 days.Primary outcome: Change in mammography density in relation to 20 mg (non-inferiority)
|
0 mg Tamoxifen
n=242 Participants
Randomised dose of tamoxifen 1 pill/day for 180 days. Primary outcome: Change in mammography density in relation to 20 mg (non-inferiority)
|
|---|---|---|---|---|---|---|
|
Drop Out Level
|
65 Participants
|
69 Participants
|
79 Participants
|
71 Participants
|
58 Participants
|
53 Participants
|
Adverse Events
20 mg Tamoxifen
Serious events: 2 serious events
Other events: 74 other events
Deaths: 0 deaths
10 mg Tamoxifen
Serious events: 1 serious events
Other events: 70 other events
Deaths: 0 deaths
5 mg Tamoxifen
Serious events: 2 serious events
Other events: 63 other events
Deaths: 0 deaths
2.5 mg Tamoxifen
Serious events: 1 serious events
Other events: 65 other events
Deaths: 0 deaths
1 mg Tamoxifen
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
0 mg Tamoxifen
Serious events: 4 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
20 mg Tamoxifen
n=241 participants at risk
Randomised dose of tamoxifen 1 pill/day for 180 days. Primary outcome: Change in mammography density in relation to 20 mg (non-inferiority)
|
10 mg Tamoxifen
n=243 participants at risk
Randomised dose of tamoxifen 1 pill/day for 180 days. Primary outcome: Change in mammography density in relation to 20 mg (non-inferiority)
|
5 mg Tamoxifen
n=240 participants at risk
Randomised dose of tamoxifen 1 pill/day for 180 days. Primary outcome: Change in mammography density in relation to 20 mg (non-inferiority)
|
2.5 mg Tamoxifen
n=235 participants at risk
Randomised dose of tamoxifen 1 pill/day for 180 days. Primary outcome: Change in mammography density in relation to 20 mg (non-inferiority)
|
1 mg Tamoxifen
n=239 participants at risk
Randomised dose of tamoxifen 1 pill/day for 180 days.Primary outcome: Change in mammography density in relation to 20 mg (non-inferiority)
|
0 mg Tamoxifen
n=242 participants at risk
Randomised dose of tamoxifen 1 pill/day for 180 days. Primary outcome: Change in mammography density in relation to 20 mg (non-inferiority)
|
|---|---|---|---|---|---|---|
|
Vascular disorders
Suspected TIA
|
0.41%
1/241 • Number of events 1 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/243 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/240 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/235 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/239 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/242 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
|
Renal and urinary disorders
Pyelonephritis
|
0.00%
0/241 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/243 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.42%
1/240 • Number of events 1 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.43%
1/235 • Number of events 1 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/239 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/242 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/241 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/243 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/240 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/235 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.42%
1/239 • Number of events 1 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.83%
2/242 • Number of events 2 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain tumour
|
0.00%
0/241 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.41%
1/243 • Number of events 1 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/240 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/235 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/239 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/242 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/241 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/243 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/240 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/235 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/239 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.41%
1/242 • Number of events 1 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/241 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/243 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.42%
1/240 • Number of events 1 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/235 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/239 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/242 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
|
Vascular disorders
Superficial thrombosis
|
0.41%
1/241 • Number of events 1 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/243 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/240 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/235 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/239 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/242 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Suspected Myeloma
|
0.00%
0/241 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/243 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/240 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/235 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.00%
0/239 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
0.41%
1/242 • Number of events 1 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
Other adverse events
| Measure |
20 mg Tamoxifen
n=241 participants at risk
Randomised dose of tamoxifen 1 pill/day for 180 days. Primary outcome: Change in mammography density in relation to 20 mg (non-inferiority)
|
10 mg Tamoxifen
n=243 participants at risk
Randomised dose of tamoxifen 1 pill/day for 180 days. Primary outcome: Change in mammography density in relation to 20 mg (non-inferiority)
|
5 mg Tamoxifen
n=240 participants at risk
Randomised dose of tamoxifen 1 pill/day for 180 days. Primary outcome: Change in mammography density in relation to 20 mg (non-inferiority)
|
2.5 mg Tamoxifen
n=235 participants at risk
Randomised dose of tamoxifen 1 pill/day for 180 days. Primary outcome: Change in mammography density in relation to 20 mg (non-inferiority)
|
1 mg Tamoxifen
n=239 participants at risk
Randomised dose of tamoxifen 1 pill/day for 180 days.Primary outcome: Change in mammography density in relation to 20 mg (non-inferiority)
|
0 mg Tamoxifen
n=242 participants at risk
Randomised dose of tamoxifen 1 pill/day for 180 days. Primary outcome: Change in mammography density in relation to 20 mg (non-inferiority)
|
|---|---|---|---|---|---|---|
|
Endocrine disorders
Hot flush
|
10.0%
24/241 • Number of events 34 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
13.2%
32/243 • Number of events 38 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
10.8%
26/240 • Number of events 47 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
10.6%
25/235 • Number of events 32 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
8.4%
20/239 • Number of events 21 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
5.4%
13/242 • Number of events 21 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
|
Endocrine disorders
Night sweats
|
7.9%
19/241 • Number of events 42 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
8.6%
21/243 • Number of events 24 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
10.0%
24/240 • Number of events 49 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
9.4%
22/235 • Number of events 33 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
4.2%
10/239 • Number of events 17 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
5.4%
13/242 • Number of events 24 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
|
Endocrine disorders
Vaginal discharge
|
7.5%
18/241 • Number of events 23 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
9.9%
24/243 • Number of events 35 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
8.8%
21/240 • Number of events 23 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
6.8%
16/235 • Number of events 23 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
3.3%
8/239 • Number of events 10 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
2.5%
6/242 • Number of events 7 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
|
Endocrine disorders
AE Free text
|
14.9%
36/241 • Number of events 46 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
8.6%
21/243 • Number of events 22 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
7.1%
17/240 • Number of events 22 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
11.5%
27/235 • Number of events 30 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
6.3%
15/239 • Number of events 22 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
8.3%
20/242 • Number of events 22 • From baseline (start of treatment) to end of study (6 months or early termination)
Adverse events where collected through an app, by phone or email. Participants where urged to report when events occurred.
|
Additional Information
PI Professor MD Per Hall
KARMA project, Karolinska Institute
Phone: +46 8 524 85000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place