Trial Outcomes & Findings for E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) - EU/Russia Study (NCT NCT02817828)
NCT ID: NCT02817828
Last Updated: 2019-10-04
Results Overview
On-treatment pregnancies are defined as pregnancies with an estimated date of conception within the in-treatment period i.e. Day 1 to 2 days after the last intake of investigational product (whether active or inactive tablet). The Pearl Index, defined as the number of pregnancies per 100 women-years of treatment was calculated as: Pearl Index = (1300\*number of on-treatment pregnancies)/number of women 28-day equivalent cycles of treatment.Only at-risk cycles were included in the denominator of the Pearl Index calculation. At-risk-cycles were defined as cycles in which no other methods of birth control (including condoms) were used by the subject as confirmed in the subject diary and during which the subject confirmed that sexual intercourse had occurred.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1577 participants
Primary outcome timeframe
Up to 12 months (13 cycles with 1 cycle = 28 days)
Results posted on
2019-10-04
Participant Flow
A total of 1,577 participants aged 18-50 years were enrolled. Of those, 1,553 started the study treatment. Twenty-four participants did not start the treatment for the following reasons: consent withdrawn (8), unspecified reason (5), protocol deviation (3), pregnancy (4), lost to follow-up (3), and adverse event not related to bleeding (1).
Participant milestones
| Measure |
15 mg E4/3 mg DRSP
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
|---|---|
|
Overall Study
STARTED
|
1553
|
|
Overall Study
COMPLETED
|
1218
|
|
Overall Study
NOT COMPLETED
|
335
|
Reasons for withdrawal
| Measure |
15 mg E4/3 mg DRSP
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
41
|
|
Overall Study
Adverse event not related to bleeding
|
104
|
|
Overall Study
Adverse event related to bleeding
|
53
|
|
Overall Study
Protocol Violation
|
11
|
|
Overall Study
Pregnancy
|
7
|
|
Overall Study
Pregnancy wish
|
15
|
|
Overall Study
Withdrawal by Subject
|
78
|
|
Overall Study
Other
|
26
|
Baseline Characteristics
E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) - EU/Russia Study
Baseline characteristics by cohort
| Measure |
15 mg E4/3 mg DRSP
n=1 Participants
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1,553 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
27.1 years
STANDARD_DEVIATION 6.86 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1,553 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1540 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
87 Participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
335 Participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
181 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
141 Participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
190 Participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
108 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
221 Participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
280 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
10 Participants
n=5 Participants
|
|
Body mass index
|
23.0 Kg/m^2
STANDARD_DEVIATION 3.469 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 months (13 cycles with 1 cycle = 28 days)Population: Participants aged 18 to 35 years, inclusive, at screening with at least 1 cycle included in the denominator.
On-treatment pregnancies are defined as pregnancies with an estimated date of conception within the in-treatment period i.e. Day 1 to 2 days after the last intake of investigational product (whether active or inactive tablet). The Pearl Index, defined as the number of pregnancies per 100 women-years of treatment was calculated as: Pearl Index = (1300\*number of on-treatment pregnancies)/number of women 28-day equivalent cycles of treatment.Only at-risk cycles were included in the denominator of the Pearl Index calculation. At-risk-cycles were defined as cycles in which no other methods of birth control (including condoms) were used by the subject as confirmed in the subject diary and during which the subject confirmed that sexual intercourse had occurred.
Outcome measures
| Measure |
15 mg E4/3 mg DRSP
n=1 Participants
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP - End of Treatment Results
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP Tablet - Intermenstrual Phase
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
|---|---|---|---|
|
The Number of On-treatment Pregnancies (With + 2-day Window) Per 100 Woman-years of Exposure (Pearl Index) in Subjects Aged 18 to 35 Years, Inclusive, at the Time of Screening
|
0.47 Pearl Index
Interval 0.15 to 1.11
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 months (13 cycles with 1 cycle = 28 days)Population: Participants aged 18 to 35 years, inclusive, at screening with at least 1 cycle included in the denominator.
On-treatment pregnancies are defined as pregnancies with an estimated date of conception within the in-treatment period i.e. Day 1 to 2 days after the last intake of investigational product (whether active or inactive tablet). The Pearl Index, defined as the number of pregnancies per 100 women-years of treatment was calculated as: Pearl Index = (1300\*number of on-treatment pregnancies)/number of women 28-day equivalent cycles of treatment. The method failure Pearl Index includes only those pregnancies that were classified as method failure and not the pregnancies due to user failure, i.e. incorrect intake of the contraceptive method. Only at-risk cycles were included in the denominator of the Pearl Index calculation. At-risk-cycles were defined as cycles in which no other methods of birth control (including condoms) were used by the subject as confirmed in the subject diary and during which the subject confirmed that sexual intercourse had occurred.
Outcome measures
| Measure |
15 mg E4/3 mg DRSP
n=1 Participants
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP - End of Treatment Results
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP Tablet - Intermenstrual Phase
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
|---|---|---|---|
|
The Number of On-treatment Pregnancies (With 2-day Window) as Assessed by the Method Failure Pearl Index in Subjects Aged 18 to 35 Years, Inclusive, at the Time of Screening
|
0.29 Method failure Pearl Index
Interval 0.06 to 0.83
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 months (13 cycles with 1 cycle = 28 days)Population: Participants aged 18 to 50 years, inclusive, at screening with at least 1 cycle included in the denominator.
On-treatment pregnancies are defined as pregnancies with an estimated date of conception within the in-treatment period i.e. Day 1 to 2 days after the last intake of investigational product (whether active or inactive tablet). The Pearl Index, defined as the number of pregnancies per 100 women-years of treatment was calculated as: Pearl Index = (1300\*number of on-treatment pregnancies)/number of women 28-day equivalent cycles of treatment.Only at-risk cycles were included in the denominator of the Pearl Index calculation. At-risk-cycles were defined as cycles in which no other methods of birth control (including condoms) were used by the subject as confirmed in the subject diary and during which the subject confirmed that sexual intercourse had occurred.
Outcome measures
| Measure |
15 mg E4/3 mg DRSP
n=1 Participants
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP - End of Treatment Results
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP Tablet - Intermenstrual Phase
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
|---|---|---|---|
|
The Number of On-treatment Pregnancies (With + 2-day Window) Per 100 Woman-years of Exposure (Pearl Index) in the Overall Study Population (18-50 Years)
|
0.41 Pearl Index
Interval 0.13 to 0.96
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 months (13 cycles with 1 cycle = 28 days)Population: Participants aged 18 to 50 years, inclusive, at screening with at least 1 cycle included in the denominator.
On-treatment pregnancies are defined as pregnancies with an estimated date of conception within the in-treatment period i.e. Day 1 to 2 days after the last intake of investigational product (whether active or inactive tablet). The Pearl Index, defined as the number of pregnancies per 100 women-years of treatment was calculated as: Pearl Index = (1300\*number of on-treatment pregnancies)/number of women 28-day equivalent cycles of treatment. The method failure Pearl Index includes only those pregnancies that were classified as method failure and not the pregnancies due to user failure, i.e. incorrect intake of the contraceptive method. Only at-risk cycles were included in the denominator of the Pearl Index calculation. At-risk-cycles were defined as cycles in which no other methods of birth control (including condoms) were used by the subject as confirmed in the subject diary and during which the subject confirmed that sexual intercourse had occurred.
Outcome measures
| Measure |
15 mg E4/3 mg DRSP
n=1 Participants
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP - End of Treatment Results
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP Tablet - Intermenstrual Phase
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
|---|---|---|---|
|
The Number of On-Treatment Pregnancies as Assessed by the Method Failure Pearl Index in the Overall Study Population (18-50 Years)
|
0.25 Method Failure Pearl Index
Interval 0.05 to 0.72
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 11 months (12 cycles with 1 cycle = 28 days)Population: Participants aged 18 to 50 years, inclusive, at screening, with evaluable cycle data for the bleeding analysis.
Unscheduled bleeding/spotting is defined as any bleeding/spotting that occurs while taking active hormones that does not meet the criteria for scheduled bleeding.
Outcome measures
| Measure |
15 mg E4/3 mg DRSP
n=1 Participants
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP - End of Treatment Results
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP Tablet - Intermenstrual Phase
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
|---|---|---|---|
|
Number of Subjects With Unscheduled Bleeding/Spotting
Cycle 1
|
354 Participants
|
—
|
—
|
|
Number of Subjects With Unscheduled Bleeding/Spotting
Cycle 2
|
282 Participants
|
—
|
—
|
|
Number of Subjects With Unscheduled Bleeding/Spotting
Cycle 3
|
250 Participants
|
—
|
—
|
|
Number of Subjects With Unscheduled Bleeding/Spotting
Cycle 4
|
249 Participants
|
—
|
—
|
|
Number of Subjects With Unscheduled Bleeding/Spotting
Cycle 5
|
238 Participants
|
—
|
—
|
|
Number of Subjects With Unscheduled Bleeding/Spotting
Cycle 6
|
207 Participants
|
—
|
—
|
|
Number of Subjects With Unscheduled Bleeding/Spotting
Cycle 7
|
170 Participants
|
—
|
—
|
|
Number of Subjects With Unscheduled Bleeding/Spotting
Cycle 8
|
202 Participants
|
—
|
—
|
|
Number of Subjects With Unscheduled Bleeding/Spotting
Cycle 9
|
182 Participants
|
—
|
—
|
|
Number of Subjects With Unscheduled Bleeding/Spotting
Cycle 10
|
168 Participants
|
—
|
—
|
|
Number of Subjects With Unscheduled Bleeding/Spotting
Cycle 11
|
155 Participants
|
—
|
—
|
|
Number of Subjects With Unscheduled Bleeding/Spotting
Cycle 12
|
154 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 11 months (12 cycles with 1 cycle = 28 days)Population: Participants aged 18 to 50 years, inclusive, at screening, with evaluable cycle data for the bleeding analysis.
Unscheduled bleeding is defined as any bleeding that occurs while taking active hormones that does not meet the criteria for scheduled bleeding and/or spotting.
Outcome measures
| Measure |
15 mg E4/3 mg DRSP
n=1 Participants
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP - End of Treatment Results
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP Tablet - Intermenstrual Phase
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
|---|---|---|---|
|
Number of Unscheduled Bleeding Days Per Cycle
Cycle 1
|
0.2 Days
Standard Deviation 0.89
|
—
|
—
|
|
Number of Unscheduled Bleeding Days Per Cycle
Cycle 2
|
0.1 Days
Standard Deviation 0.66
|
—
|
—
|
|
Number of Unscheduled Bleeding Days Per Cycle
Cycle 3
|
0.1 Days
Standard Deviation 0.67
|
—
|
—
|
|
Number of Unscheduled Bleeding Days Per Cycle
Cycle 4
|
0.2 Days
Standard Deviation 0.79
|
—
|
—
|
|
Number of Unscheduled Bleeding Days Per Cycle
Cycle 5
|
0.1 Days
Standard Deviation 0.70
|
—
|
—
|
|
Number of Unscheduled Bleeding Days Per Cycle
Cycle 6
|
0.1 Days
Standard Deviation 0.80
|
—
|
—
|
|
Number of Unscheduled Bleeding Days Per Cycle
Cycle 7
|
0.1 Days
Standard Deviation 0.68
|
—
|
—
|
|
Number of Unscheduled Bleeding Days Per Cycle
Cycle 8
|
0.1 Days
Standard Deviation 0.72
|
—
|
—
|
|
Number of Unscheduled Bleeding Days Per Cycle
Cycle 9
|
0.1 Days
Standard Deviation 0.70
|
—
|
—
|
|
Number of Unscheduled Bleeding Days Per Cycle
Cycle 10
|
0.1 Days
Standard Deviation 0.61
|
—
|
—
|
|
Number of Unscheduled Bleeding Days Per Cycle
Cycle 11
|
0.1 Days
Standard Deviation 0.72
|
—
|
—
|
|
Number of Unscheduled Bleeding Days Per Cycle
Cycle 12
|
0.1 Days
Standard Deviation 0.68
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 11 months (12 cycles with 1 cycle = 28 days)Population: Participants aged 18 to 50 years, inclusive, at screening, with evaluable cycle data for the bleeding analysis.
Unscheduled spotting is defined as any spotting that occurs while taking active hormones that does not meet the criteria for scheduled bleeding and/or spotting.
Outcome measures
| Measure |
15 mg E4/3 mg DRSP
n=1 Participants
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP - End of Treatment Results
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP Tablet - Intermenstrual Phase
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
|---|---|---|---|
|
Number of Unscheduled Spotting Days Per Cycle
Cycle 1
|
0.8 Days
Standard Deviation 1.99
|
—
|
—
|
|
Number of Unscheduled Spotting Days Per Cycle
Cycle 2
|
0.5 Days
Standard Deviation 1.50
|
—
|
—
|
|
Number of Unscheduled Spotting Days Per Cycle
Cycle 3
|
0.5 Days
Standard Deviation 1.46
|
—
|
—
|
|
Number of Unscheduled Spotting Days Per Cycle
Cycle 4
|
0.5 Days
Standard Deviation 1.55
|
—
|
—
|
|
Number of Unscheduled Spotting Days Per Cycle
Cycle 5
|
0.5 Days
Standard Deviation 1.35
|
—
|
—
|
|
Number of Unscheduled Spotting Days Per Cycle
Cycle 6
|
0.4 Days
Standard Deviation 1.24
|
—
|
—
|
|
Number of Unscheduled Spotting Days Per Cycle
Cycle 7
|
0.4 Days
Standard Deviation 1.17
|
—
|
—
|
|
Number of Unscheduled Spotting Days Per Cycle
Cycle 8
|
0.4 Days
Standard Deviation 1.19
|
—
|
—
|
|
Number of Unscheduled Spotting Days Per Cycle
Cycle 9
|
0.4 Days
Standard Deviation 0.13
|
—
|
—
|
|
Number of Unscheduled Spotting Days Per Cycle
Cycle 10
|
0.4 Days
Standard Deviation 1.25
|
—
|
—
|
|
Number of Unscheduled Spotting Days Per Cycle
Cycle 11
|
0.3 Days
Standard Deviation 1.18
|
—
|
—
|
|
Number of Unscheduled Spotting Days Per Cycle
Cycle 12
|
0.4 Days
Standard Deviation 1.23
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 11 months (12 cycles with 1 cycle = 28 days)Population: Participants aged 18 to 50 years, inclusive, at screening, with evaluable cycle data for the bleeding analysis.
Scheduled bleeding/spotting is defined as any bleeding/spotting that occurs during the hormone-free interval (i.e. Days 25 - 28) and continues through Days 1-3 of the subsequent active cycle.
Outcome measures
| Measure |
15 mg E4/3 mg DRSP
n=1 Participants
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP - End of Treatment Results
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP Tablet - Intermenstrual Phase
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
|---|---|---|---|
|
Number of Subjects With Absence of Scheduled Bleeding and/or Spotting
Cycle 4
|
83 Participants
|
—
|
—
|
|
Number of Subjects With Absence of Scheduled Bleeding and/or Spotting
Cycle 5
|
91 Participants
|
—
|
—
|
|
Number of Subjects With Absence of Scheduled Bleeding and/or Spotting
Cycle 6
|
91 Participants
|
—
|
—
|
|
Number of Subjects With Absence of Scheduled Bleeding and/or Spotting
Cycle 7
|
90 Participants
|
—
|
—
|
|
Number of Subjects With Absence of Scheduled Bleeding and/or Spotting
Cycle 8
|
103 Participants
|
—
|
—
|
|
Number of Subjects With Absence of Scheduled Bleeding and/or Spotting
Cycle 9
|
92 Participants
|
—
|
—
|
|
Number of Subjects With Absence of Scheduled Bleeding and/or Spotting
Cycle 1
|
84 Participants
|
—
|
—
|
|
Number of Subjects With Absence of Scheduled Bleeding and/or Spotting
Cycle 2
|
90 Participants
|
—
|
—
|
|
Number of Subjects With Absence of Scheduled Bleeding and/or Spotting
Cycle 3
|
105 Participants
|
—
|
—
|
|
Number of Subjects With Absence of Scheduled Bleeding and/or Spotting
Cycle 10
|
89 Participants
|
—
|
—
|
|
Number of Subjects With Absence of Scheduled Bleeding and/or Spotting
Cycle 11
|
80 Participants
|
—
|
—
|
|
Number of Subjects With Absence of Scheduled Bleeding and/or Spotting
Cycle 12
|
94 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 11 months (12 cycles with 1 cycle = 28 days)Population: Participants aged 18 to 50 years, inclusive, at screening, with evaluable cycle data for the bleeding analysis.
Scheduled bleeding and /or spotting is defined as any bleeding and/or spotting that occurs during the hormone-free interval (i.e. Days 25 - 28) and continues through Days 1-3 of the subsequent active cycle.
Outcome measures
| Measure |
15 mg E4/3 mg DRSP
n=1 Participants
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP - End of Treatment Results
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP Tablet - Intermenstrual Phase
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
|---|---|---|---|
|
Number of Scheduled Bleeding and/or Spotting Days Per Cycle
Cycle 1
|
6.1 Days
Standard Deviation 4.95
|
—
|
—
|
|
Number of Scheduled Bleeding and/or Spotting Days Per Cycle
Cycle 2
|
5.3 Days
Standard Deviation 3.62
|
—
|
—
|
|
Number of Scheduled Bleeding and/or Spotting Days Per Cycle
Cycle 3
|
5.2 Days
Standard Deviation 3.99
|
—
|
—
|
|
Number of Scheduled Bleeding and/or Spotting Days Per Cycle
Cycle 4
|
5.0 Days
Standard Deviation 3.14
|
—
|
—
|
|
Number of Scheduled Bleeding and/or Spotting Days Per Cycle
Cycle 5
|
4.9 Days
Standard Deviation 3.43
|
—
|
—
|
|
Number of Scheduled Bleeding and/or Spotting Days Per Cycle
Cycle 6
|
4.9 Days
Standard Deviation 3.34
|
—
|
—
|
|
Number of Scheduled Bleeding and/or Spotting Days Per Cycle
Cycle 7
|
4.7 Days
Standard Deviation 2.80
|
—
|
—
|
|
Number of Scheduled Bleeding and/or Spotting Days Per Cycle
Cycle 8
|
4.8 Days
Standard Deviation 3.85
|
—
|
—
|
|
Number of Scheduled Bleeding and/or Spotting Days Per Cycle
Cycle 9
|
4.7 Days
Standard Deviation 2.87
|
—
|
—
|
|
Number of Scheduled Bleeding and/or Spotting Days Per Cycle
Cycle 10
|
4.6 Days
Standard Deviation 2.69
|
—
|
—
|
|
Number of Scheduled Bleeding and/or Spotting Days Per Cycle
Cycle 11
|
4.7 Days
Standard Deviation 3.16
|
—
|
—
|
|
Number of Scheduled Bleeding and/or Spotting Days Per Cycle
Cycle 12
|
4.6 Days
Standard Deviation 2.97
|
—
|
—
|
SECONDARY outcome
Timeframe: From screening to end of treatment (12 months)Population: Participants aged 18 to 50 years, inclusive, at screening, who received at least one dose of investigational product.
Vital signs included sitting systolic and diastolic blood pressures, and heart rate.
Outcome measures
| Measure |
15 mg E4/3 mg DRSP
n=1 Participants
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP - End of Treatment Results
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP Tablet - Intermenstrual Phase
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
|---|---|---|---|
|
Number of Subjects With Abnormal Vital Signs
|
15 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From screening to end of treatment (12 months)Population: Participants aged 18 to 50 years, inclusive, at screening, who received at least one dose of investigational product.
Laboratory assessment included blood hematology, biochemistry, and lipids
Outcome measures
| Measure |
15 mg E4/3 mg DRSP
n=1 Participants
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP - End of Treatment Results
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP Tablet - Intermenstrual Phase
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
|---|---|---|---|
|
Number of Subjects With Abnormal Laboratory Assessment Results
|
55 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From screening to end of treatment (12 months)Population: Participants aged 18 to 50 years, inclusive, at screening, who received at least one dose of investigational product with baseline and end of treatment (EOT) results.
Physical examinations included an evaluation of body as a whole, skin, head, eyes, ears, nose, and throat, neck, cardiovascular, respiratory, musculoskeletal, neurologic, lymphatic/thyroid, abdomen. When reporting the results of the physical examination, the use of the "Abnormal" category was reserved for findings that were considered clinically significant, in the opinion of the Investigator; the "Normal" category included "Abnormal" results that were not clinically significant, as well as no findings.
Outcome measures
| Measure |
15 mg E4/3 mg DRSP
n=1 Participants
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP - End of Treatment Results
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP Tablet - Intermenstrual Phase
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
|---|---|---|---|
|
Number of Subjects With Abnormal Physical Examination Results
Body as a whole - Baseline · Normal
|
1548 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Body as a whole - Baseline · Abnormal
|
5 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Body as a whole - Baseline · Not done
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Body as a whole - EOT · Normal
|
1493 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Body as a whole - EOT · Abnormal
|
5 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Body as a whole - EOT · Not done
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Skin - Baseline · Normal
|
1537 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Skin - Baseline · Abnormal
|
16 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Skin - Baseline · Not done
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Skin - EOT · Normal
|
1,476 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Skin - EOT · Abnormal
|
22 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Skin - EOT · Not done
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Head, Eyes, Ears, Nose and Throat - Baseline · Normal
|
1,543 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Head, Eyes, Ears, Nose and Throat - Baseline · Abnormal
|
10 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Head, Eyes, Ears, Nose and Throat - Baseline · Not done
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Head, Eyes, Ears, Nose and Throat - EOT · Normal
|
1,492 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Head, Eyes, Ears, Nose and Throat - EOT · Abnormal
|
3 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Head, Eyes, Ears, Nose and Throat - EOT · Not done
|
3 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Neck - Baseline · Normal
|
1,552 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Neck - Baseline · Abnormal
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Neck - Baseline · Not done
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Neck - EOT · Normal
|
1,495 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Neck - EOT · Abnormal
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Neck - EOT · Not done
|
2 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Cardiovascular - Baseline · Normal
|
1,553 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Cardiovascular - Baseline · Abnormal
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Cardiovascular - Baseline · Not done
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Cardiovascular - EOT · Normal
|
1,496 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Cardiovascular - EOT · Abnormal
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Cardiovascular - EOT · Not done
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Respiratory - Baseline · Normal
|
1,551 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Respiratory - Baseline · Abnormal
|
2 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Respiratory - Baseline · Not done
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Respiratory - EOT · Normal
|
1,496 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Respiratory - EOT · Abnormal
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Respiratory - EOT · Not done
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Musculoskeletal - Baseline · Normal
|
1,553 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Musculoskeletal - Baseline · Abnormal
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Musculoskeletal - Baseline · Not done
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Musculoskeletal - EOT · Normal
|
1,495 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Musculoskeletal - EOT · Abnormal
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Musculoskeletal - EOT · Not done
|
2 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Neurologic - Baseline · Normal
|
1,553 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Neurologic - Baseline · Abnormal
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Neurologic - Baseline · Not done
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Neurologic - EOT · Normal
|
1,494 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Neurologic - EOT · Abnormal
|
2 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Neurologic - EOT · Not done
|
2 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Lymphatic/Thyroid - Baseline · Normal
|
1,549 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Lymphatic/Thyroid - Baseline · Abnormal
|
2 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Lymphatic/Thyroid - Baseline · Not done
|
2 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Lymphatic/Thyroid - EOT · Normal
|
1,494 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Lymphatic/Thyroid - EOT · Abnormal
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Lymphatic/Thyroid - EOT · Not done
|
3 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Abdomen - Baseline · Normal
|
1,553 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Abdomen - Baseline · Abnormal
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Abdomen - Baseline · Not done
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Abdomen - EOT · Normal
|
1,496 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Abdomen - EOT · Abnormal
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Physical Examination Results
Abdomen - EOT · Not done
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From screening to end of treatment (12 months)Population: Participants aged 18 to 50 years, inclusive, at screening, who received at least one dose of investigational product with baseline and end of treatment (EOT) gynecological results.
Gynecological examinations included breast examination (performed by palpation) and assessment of the adnexa, cervix, uterus, vagina, and external genitalia. When reporting the results, the use of the "Abnormal" category was reserved for findings that were considered clinically significant, in the opinion of the Investigator; the "Normal" category included "Abnormal" results that were not clinically significant, as well as no findings.
Outcome measures
| Measure |
15 mg E4/3 mg DRSP
n=1 Participants
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP - End of Treatment Results
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP Tablet - Intermenstrual Phase
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
|---|---|---|---|
|
Number of Subjects With Abnormal Gynecological Examination Results
Breast - Baseline · Normal
|
1,545 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
Breast - Baseline · Abnormal
|
8 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
Breast - Baseline · Not done
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
Breast - EOT · Normal
|
1,485 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
Breast - EOT · Abnormal
|
13 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
Breast - EOT · Not done
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
Adnexa - Baseline · Normal
|
1,549 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
Adnexa - Baseline · Abnormal
|
4 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
Adnexa - Baseline · Not done
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
Adnexa - EOT · Normal
|
1,496 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
Adnexa - EOT · Abnormal
|
2 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
Adnexa - EOT · Not done
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
Cervix - Baseline · Normal
|
1,532 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
Cervix - Baseline · Abnormal
|
21 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
Cervix - Baseline · Not done
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
Cervix - EOT · Normal
|
1,485 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
Cervix - EOT · Abnormal
|
13 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
Cervix - EOT · Not done
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
Uterus - Baseline · Normal
|
1,542 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
Uterus - Baseline · Abnormal
|
11 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
Uterus - Baseline · Not done
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
Uterus - EOT · Normal
|
1,492 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
Uterus - EOT · Abnormal
|
6 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
Uterus - EOT · Not done
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
Vagina - Baseline · Normal
|
1,545 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
Vagina - Baseline · Abnormal
|
8 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
Vagina - Baseline · Not done
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
Vagina - EOT · Normal
|
1,489 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
Vagina - EOT · Abnormal
|
8 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
Vagina - EOT · Not done
|
2 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
External genitalia - Baseline · Normal
|
1,552 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
External genitalia - Baseline · Abnormal
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
External genitalia - Baseline · Not done
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
External genitalia - EOT · Normal
|
1,497 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
External genitalia - EOT · Abnormal
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Abnormal Gynecological Examination Results
External genitalia - EOT · Not done
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and end of treatment (up to 13 cycles with 1 cycle = 28 days)Population: Participants aged 18 to 50 years, inclusive, at screening with an evaluable endometrial biopsies both at screening and end of treatment.
Endometrial biopsies was obtained from a subset of subjects included in the endometrial safety substudy at the screening visit and at the end of treatment visit if the subject has completed at least 10 cycles.
Outcome measures
| Measure |
15 mg E4/3 mg DRSP
n=108 Participants
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP - End of Treatment Results
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP Tablet - Intermenstrual Phase
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
|---|---|---|---|
|
Endometrial Biopsy Histology at Screening and End of Treatment
End of Treatment · Benign histology:Atrophic
|
11 Participants
|
—
|
—
|
|
Endometrial Biopsy Histology at Screening and End of Treatment
End of Treatment · Benign histology: Inactive
|
61 Participants
|
—
|
—
|
|
Endometrial Biopsy Histology at Screening and End of Treatment
Baseline · No tissue
|
0 Participants
|
—
|
—
|
|
Endometrial Biopsy Histology at Screening and End of Treatment
Baseline · Tissue insufficient for diagnosis
|
1 Participants
|
—
|
—
|
|
Endometrial Biopsy Histology at Screening and End of Treatment
Baseline · Benign histology:Atrophic
|
2 Participants
|
—
|
—
|
|
Endometrial Biopsy Histology at Screening and End of Treatment
Baseline · Benign histology: Inactive
|
7 Participants
|
—
|
—
|
|
Endometrial Biopsy Histology at Screening and End of Treatment
Baseline · Benign histology:Proliferative
|
76 Participants
|
—
|
—
|
|
Endometrial Biopsy Histology at Screening and End of Treatment
Baseline · Secretory
|
22 Participants
|
—
|
—
|
|
Endometrial Biopsy Histology at Screening and End of Treatment
Baseline · Menstrual type
|
0 Participants
|
—
|
—
|
|
Endometrial Biopsy Histology at Screening and End of Treatment
Baseline · Simple hyperplasia without atypia
|
0 Participants
|
—
|
—
|
|
Endometrial Biopsy Histology at Screening and End of Treatment
Baseline · Complex hyperplasia without atypia
|
0 Participants
|
—
|
—
|
|
Endometrial Biopsy Histology at Screening and End of Treatment
Baseline · Pre-malignant/Malignant histology
|
0 Participants
|
—
|
—
|
|
Endometrial Biopsy Histology at Screening and End of Treatment
End of Treatment · No tissue
|
0 Participants
|
—
|
—
|
|
Endometrial Biopsy Histology at Screening and End of Treatment
End of Treatment · Tissue insufficient for diagnosis
|
9 Participants
|
—
|
—
|
|
Endometrial Biopsy Histology at Screening and End of Treatment
End of Treatment · Benign histology:Proliferative
|
22 Participants
|
—
|
—
|
|
Endometrial Biopsy Histology at Screening and End of Treatment
End of Treatment · Secretory
|
5 Participants
|
—
|
—
|
|
Endometrial Biopsy Histology at Screening and End of Treatment
End of Treatment · Menstrual type
|
0 Participants
|
—
|
—
|
|
Endometrial Biopsy Histology at Screening and End of Treatment
End of Treatment · Simple hyperplasia without atypia
|
0 Participants
|
—
|
—
|
|
Endometrial Biopsy Histology at Screening and End of Treatment
End of Treatment · Complex hyperplasia without atypia
|
0 Participants
|
—
|
—
|
|
Endometrial Biopsy Histology at Screening and End of Treatment
End of Treatment · Pre-malignant/Malignant histology
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Cycle 13 (1 cycle = 28 days)Population: Participants aged 18 to 50 years, inclusive, at screening with baseline and end of treatment Q-LES-Q-SF results.
The Q-LES-Q-SF is a self-report measure designed to assess the degree of enjoyment and satisfaction in daily functioning. Participants were asked to rate 16 different items on a 5-point scale where score 1 = very poor and score 5 = very good. A raw total score is calculated by summing the first 14 items and ranges from 14 to 70 with a higher scores indicating higher life enjoyment and satisfaction. The raw total score is then transformed into a percentage maximum score using the following formula: (raw total score-minimum score)/(maximum possible raw score-minimum score). In addition, the last two items (15 and 16) are two global items that are scored individually. These items rate "satisfaction with medicine" and "overall life satisfaction over the past week".
Outcome measures
| Measure |
15 mg E4/3 mg DRSP
n=1 Participants
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP - End of Treatment Results
n=1 Participants
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP Tablet - Intermenstrual Phase
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
|---|---|---|---|
|
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Results at Baseline and End of Treatment - Percentage Maximum (Sum of First 14 Items)
|
73.4 Percentage maximum score on a scale
Standard Deviation 12.77
|
73.8 Percentage maximum score on a scale
Standard Deviation 12.82
|
—
|
SECONDARY outcome
Timeframe: Baseline and Cycle 13 (1 cycle = 28 days)Population: Participants aged 18 to 50 years, inclusive, at screening with baseline and end of treatment Q-LES-Q-SF results.
The Q-LES-Q-SF is a self-report measure designed to assess the degree of enjoyment and satisfaction in daily functioning. Participants were asked to rate 16 different items on a 5-point scale where score 1 = very poor and score 5 = very good. A raw total score is calculated by summing the first 14 items and ranges from 14 to 70 with a higher scores indicating higher life enjoyment and satisfaction. The raw total score is then transformed into a percentage maximum score using the following formula: (raw total score-minimum score)/(maximum possible raw score-minimum score). In addition, the last two items (15 and 16) are two global items that are scored individually. These items rate "satisfaction with medicine" and "overall life satisfaction over the past week".
Outcome measures
| Measure |
15 mg E4/3 mg DRSP
n=1 Participants
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP - End of Treatment Results
n=1 Participants
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP Tablet - Intermenstrual Phase
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
|---|---|---|---|
|
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Results at Baseline and End of Treatment - Satisfaction With Medicine and Overall Life Satisfaction Over the Past Week
Satisfaction with medicine
|
4.0 Units on a scale
Standard Deviation 0.78
|
4.0 Units on a scale
Standard Deviation 0.77
|
—
|
|
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Results at Baseline and End of Treatment - Satisfaction With Medicine and Overall Life Satisfaction Over the Past Week
Overall life statisfaction over the past week
|
4.0 Units on a scale
Standard Deviation 0.68
|
4.0 Units on a scale
Standard Deviation 0.70
|
—
|
SECONDARY outcome
Timeframe: Baseline and Cycle 13 (1 cycle = 28 days)Population: Participants aged 18 to 50 years, inclusive, at screening with both baseline and end of treatment MDQ results.
The MDQ is a standard method for measuring cyclical perimenstrual symptoms. The participants rated common symptoms and feelings associated with menstruation using the following scale: 0 (no experience of symptom), 1 (present, mild), 2 (present, moderate), 3 (present, strong),and 4 (present, severe) observed during pre-menstrual (4 days before menstruation), menstrual (most recent flow) and intermenstrual (remainder of the cycle) phases. Reported values are values at Cycle 13 minus values at Baseline. An overall positive change from baseline represents an increase in symptom or feeling severity.
Outcome measures
| Measure |
15 mg E4/3 mg DRSP
n=1 Participants
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP - End of Treatment Results
n=1 Participants
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
15 mg E4/3 mg DRSP Tablet - Intermenstrual Phase
n=1 Participants
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
|---|---|---|---|
|
Change From Baseline to End of Treatment in the Score of the Menstrual Distress Questionnaire (MDQ)
Pain
|
-0.4 units on a scale
Standard Deviation 3.6
|
-0.1 units on a scale
Standard Deviation 2.96
|
-0.1 units on a scale
Standard Deviation 2.67
|
|
Change From Baseline to End of Treatment in the Score of the Menstrual Distress Questionnaire (MDQ)
Water retention
|
-0.1 units on a scale
Standard Deviation 2.61
|
-0.1 units on a scale
Standard Deviation 2.57
|
0.0 units on a scale
Standard Deviation 2.09
|
|
Change From Baseline to End of Treatment in the Score of the Menstrual Distress Questionnaire (MDQ)
Autonomic reactions
|
-0.1 units on a scale
Standard Deviation 1.42
|
-0.0 units on a scale
Standard Deviation 1.30
|
-0.0 units on a scale
Standard Deviation 1.22
|
|
Change From Baseline to End of Treatment in the Score of the Menstrual Distress Questionnaire (MDQ)
Negative affect
|
-0.4 units on a scale
Standard Deviation 4.90
|
-0.3 units on a scale
Standard Deviation 4.70
|
-0.1 units on a scale
Standard Deviation 3.93
|
|
Change From Baseline to End of Treatment in the Score of the Menstrual Distress Questionnaire (MDQ)
Impaired concentration
|
0.0 units on a scale
Standard Deviation 2.67
|
-0.0 units on a scale
Standard Deviation 2.55
|
0.0 units on a scale
Standard Deviation 2.23
|
|
Change From Baseline to End of Treatment in the Score of the Menstrual Distress Questionnaire (MDQ)
Behaviour change
|
-0.1 units on a scale
Standard Deviation 2.86
|
-0.1 units on a scale
Standard Deviation 2.55
|
-0.0 units on a scale
Standard Deviation 1.99
|
|
Change From Baseline to End of Treatment in the Score of the Menstrual Distress Questionnaire (MDQ)
Arousal
|
-0.3 units on a scale
Standard Deviation 3.46
|
-0.3 units on a scale
Standard Deviation 3.62
|
-0.3 units on a scale
Standard Deviation 3.91
|
|
Change From Baseline to End of Treatment in the Score of the Menstrual Distress Questionnaire (MDQ)
Control
|
0.0 units on a scale
Standard Deviation 1.52
|
0.0 units on a scale
Standard Deviation 1.57
|
0.0 units on a scale
Standard Deviation 1.63
|
Adverse Events
15 mg E4/3 mg DRSP
Serious events: 13 serious events
Other events: 784 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
15 mg E4/3 mg DRSP
n=1553 participants at risk
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
|---|---|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.06%
1/1553 • Number of events 1 • From screening to end of treatment (13 months)
|
|
Injury, poisoning and procedural complications
Concussion
|
0.06%
1/1553 • Number of events 1 • From screening to end of treatment (13 months)
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.06%
1/1553 • Number of events 1 • From screening to end of treatment (13 months)
|
|
Nervous system disorders
Migraine without aura
|
0.06%
1/1553 • Number of events 1 • From screening to end of treatment (13 months)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.06%
1/1553 • Number of events 1 • From screening to end of treatment (13 months)
|
|
General disorders
Pyrexia
|
0.06%
1/1553 • Number of events 1 • From screening to end of treatment (13 months)
|
|
Ear and labyrinth disorders
Vertigo
|
0.06%
1/1553 • Number of events 1 • From screening to end of treatment (13 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.06%
1/1553 • Number of events 1 • From screening to end of treatment (13 months)
|
|
Gastrointestinal disorders
Colitis
|
0.06%
1/1553 • Number of events 1 • From screening to end of treatment (13 months)
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.06%
1/1553 • Number of events 1 • From screening to end of treatment (13 months)
|
|
Infections and infestations
Appendicitis
|
0.13%
2/1553 • Number of events 2 • From screening to end of treatment (13 months)
|
|
Infections and infestations
Abscess limb
|
0.06%
1/1553 • Number of events 1 • From screening to end of treatment (13 months)
|
|
Vascular disorders
Venous thrombosis
|
0.06%
1/1553 • Number of events 1 • From screening to end of treatment (13 months)
|
Other adverse events
| Measure |
15 mg E4/3 mg DRSP
n=1553 participants at risk
15 mg E4/3 mg DRSP tablet
15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
|
|---|---|
|
Investigations
Weight increased
|
2.3%
36/1553 • Number of events 36 • From screening to end of treatment (13 months)
|
|
Investigations
Low density lipoprotein increased
|
1.2%
18/1553 • Number of events 19 • From screening to end of treatment (13 months)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.97%
15/1553 • Number of events 16 • From screening to end of treatment (13 months)
|
|
Nervous system disorders
Dizziness
|
1.2%
19/1553 • Number of events 24 • From screening to end of treatment (13 months)
|
|
Nervous system disorders
Headache
|
7.7%
120/1553 • Number of events 171 • From screening to end of treatment (13 months)
|
|
Nervous system disorders
Mood altered
|
1.2%
19/1553 • Number of events 19 • From screening to end of treatment (13 months)
|
|
Nervous system disorders
Libido decreased
|
2.4%
38/1553 • Number of events 43 • From screening to end of treatment (13 months)
|
|
Nervous system disorders
Irritability
|
1.2%
18/1553 • Number of events 18 • From screening to end of treatment (13 months)
|
|
Nervous system disorders
Mood swings
|
1.2%
18/1553 • Number of events 18 • From screening to end of treatment (13 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
2.3%
36/1553 • Number of events 48 • From screening to end of treatment (13 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
25/1553 • Number of events 45 • From screening to end of treatment (13 months)
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
27/1553 • Number of events 49 • From screening to end of treatment (13 months)
|
|
Gastrointestinal disorders
Nausea
|
1.3%
20/1553 • Number of events 25 • From screening to end of treatment (13 months)
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
4.8%
74/1553 • Number of events 151 • From screening to end of treatment (13 months)
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
3.0%
47/1553 • Number of events 74 • From screening to end of treatment (13 months)
|
|
Reproductive system and breast disorders
Metrorrhagia
|
5.5%
85/1553 • Number of events 156 • From screening to end of treatment (13 months)
|
|
Reproductive system and breast disorders
Breast pain
|
2.7%
42/1553 • Number of events 51 • From screening to end of treatment (13 months)
|
|
Reproductive system and breast disorders
Vaginal discharge
|
1.0%
16/1553 • Number of events 19 • From screening to end of treatment (13 months)
|
|
Skin and subcutaneous tissue disorders
Acne
|
4.2%
65/1553 • Number of events 69 • From screening to end of treatment (13 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
19/1553 • Number of events 20 • From screening to end of treatment (13 months)
|
|
Infections and infestations
Tonsilitis
|
1.9%
29/1553 • Number of events 31 • From screening to end of treatment (13 months)
|
|
Infections and infestations
Vaginal infection
|
1.9%
29/1553 • Number of events 33 • From screening to end of treatment (13 months)
|
|
Infections and infestations
Influenza
|
1.8%
28/1553 • Number of events 30 • From screening to end of treatment (13 months)
|
|
Infections and infestations
Urinary tract infection
|
1.9%
30/1553 • Number of events 35 • From screening to end of treatment (13 months)
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
1.1%
17/1553 • Number of events 22 • From screening to end of treatment (13 months)
|
|
Infections and infestations
Bronchitis
|
0.97%
15/1553 • Number of events 16 • From screening to end of treatment (13 months)
|
|
Infections and infestations
Sinusitis
|
1.1%
17/1553 • Number of events 19 • From screening to end of treatment (13 months)
|
|
Infections and infestations
Respiratory tract infection
|
1.2%
18/1553 • Number of events 19 • From screening to end of treatment (13 months)
|
|
Infections and infestations
Cystitis
|
1.5%
24/1553 • Number of events 29 • From screening to end of treatment (13 months)
|
|
Infections and infestations
Vulvovaginal candidiasis
|
1.3%
20/1553 • Number of events 23 • From screening to end of treatment (13 months)
|
Additional Information
Mithra Pharmaceuticals SA Pharma Department
Estetra SPRL
Phone: +3243492822
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place