Trial Outcomes & Findings for Study to Evaluate Cycle Control With Norgestimate/Ethinyl Estradiol and Drospirenone/Ethinyl Estradiol in Healthy Sexually Active Females (NCT NCT00745901)
NCT ID: NCT00745901
Last Updated: 2019-03-19
Results Overview
cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
355 participants
Primary outcome timeframe
Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)
Results posted on
2019-03-19
Participant Flow
Participant milestones
| Measure |
NGM/25mcg EE
NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
|
DRSP/20mcg EE
DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
|
|---|---|---|
|
Overall Study
STARTED
|
178
|
177
|
|
Overall Study
COMPLETED
|
154
|
156
|
|
Overall Study
NOT COMPLETED
|
24
|
21
|
Reasons for withdrawal
| Measure |
NGM/25mcg EE
NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
|
DRSP/20mcg EE
DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
4
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
7
|
4
|
|
Overall Study
Pregnancy
|
2
|
4
|
|
Overall Study
Lack of compliance
|
2
|
2
|
|
Overall Study
Patient's next menses did not start with
|
1
|
0
|
|
Overall Study
Results of Pap smear at Vis 1 malignant
|
0
|
2
|
|
Overall Study
Chlamydia test at Visit 1 was positive
|
1
|
1
|
|
Overall Study
Patient didn't take any study medication
|
7
|
3
|
Baseline Characteristics
Study to Evaluate Cycle Control With Norgestimate/Ethinyl Estradiol and Drospirenone/Ethinyl Estradiol in Healthy Sexually Active Females
Baseline characteristics by cohort
| Measure |
NGM/25mcg EE
n=178 Participants
NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
|
DRSP/20mcg EE
n=177 Participants
DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
|
Total
n=355 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<18 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Customized
>= 18 and < 65 years
|
178 participants
n=5 Participants
|
177 participants
n=7 Participants
|
355 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Continuous
|
27.2 years
STANDARD_DEVIATION 6.70 • n=5 Participants
|
27.2 years
STANDARD_DEVIATION 6.52 • n=7 Participants
|
27.2 years
STANDARD_DEVIATION 6.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
178 Participants
n=5 Participants
|
177 Participants
n=7 Participants
|
355 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)Population: Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.
cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.
Outcome measures
| Measure |
NGM/25mcg EE
n=165 Participants
NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
|
DRSP/20mcg EE
n=167 Participants
DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
|
|---|---|---|
|
Number of Days of Unscheduled Blood Loss - Cycle 1
|
1.9 Days
Standard Deviation 3.14
|
2.0 Days
Standard Deviation 3.53
|
PRIMARY outcome
Timeframe: Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)Population: Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2.
cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.
Outcome measures
| Measure |
NGM/25mcg EE
n=160 Participants
NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
|
DRSP/20mcg EE
n=165 Participants
DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
|
|---|---|---|
|
Number of Days of Unscheduled Blood Loss - Cycle 2
|
1.3 Days
Standard Deviation 2.49
|
1.9 Days
Standard Deviation 2.86
|
PRIMARY outcome
Timeframe: Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)Population: Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3.
Number of Days of Unscheduled Blood Loss - Cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.
Outcome measures
| Measure |
NGM/25mcg EE
n=157 Participants
NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
|
DRSP/20mcg EE
n=159 Participants
DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
|
|---|---|---|
|
Number of Days of Unscheduled Blood Loss - Cycle 3
|
1.4 Days
Standard Deviation 2.33
|
2.4 Days
Standard Deviation 2.86
|
PRIMARY outcome
Timeframe: Cycle 1 to Cycle 3 (Day 8 to Day 80)Population: Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.
cycle control between treatment groups, for three 28-day cycles. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.
Outcome measures
| Measure |
NGM/25mcg EE
n=165 Participants
NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
|
DRSP/20mcg EE
n=167 Participants
DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
|
|---|---|---|
|
Overall Number of Days of Unscheduled Blood Loss
|
4.6 Days
Standard Deviation 5.33
|
6.1 Days
Standard Deviation 6.07
|
PRIMARY outcome
Timeframe: Cycle 1 to Cycle 3 (Day 8 to Day 80)Population: Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.
Unscheduled blood loss episodes are bounded on both sides by at least 1 non- bleeding day.
Outcome measures
| Measure |
NGM/25mcg EE
n=165 Participants
NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
|
DRSP/20mcg EE
n=167 Participants
DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
|
|---|---|---|
|
Number of Participants With the Indicated Number of Unscheduled Blood Loss Episodes
0 Episode
|
55 Participants
|
29 Participants
|
|
Number of Participants With the Indicated Number of Unscheduled Blood Loss Episodes
1 Episode
|
46 Participants
|
41 Participants
|
|
Number of Participants With the Indicated Number of Unscheduled Blood Loss Episodes
2 Episodes
|
23 Participants
|
50 Participants
|
|
Number of Participants With the Indicated Number of Unscheduled Blood Loss Episodes
3 Episodes
|
21 Participants
|
22 Participants
|
|
Number of Participants With the Indicated Number of Unscheduled Blood Loss Episodes
4 Episodes
|
13 Participants
|
11 Participants
|
|
Number of Participants With the Indicated Number of Unscheduled Blood Loss Episodes
5 Episodes
|
7 Participants
|
8 Participants
|
|
Number of Participants With the Indicated Number of Unscheduled Blood Loss Episodes
6 Episodes
|
0 Participants
|
2 Participants
|
|
Number of Participants With the Indicated Number of Unscheduled Blood Loss Episodes
8 Episodes
|
0 Participants
|
3 Participants
|
|
Number of Participants With the Indicated Number of Unscheduled Blood Loss Episodes
9 Episodes
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (Day 22 to 32 for NGM/25mcg EE and day 25 to 32 for DRSP/20mcg EE)Population: Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.
cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.
Outcome measures
| Measure |
NGM/25mcg EE
n=165 Participants
NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
|
DRSP/20mcg EE
n=167 Participants
DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
|
|---|---|---|
|
Number of Days of Scheduled Blood Loss - Cycle 1
|
4.3 Days
Standard Deviation 2.09
|
3.2 Days
Standard Deviation 2.35
|
PRIMARY outcome
Timeframe: Cycle 2 (Day 50 to 60 for NGM/25mcg EE and day 53 to 60 for DRSP/20mcg EE)Population: Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2.
cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.
Outcome measures
| Measure |
NGM/25mcg EE
n=160 Participants
NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
|
DRSP/20mcg EE
n=165 Participants
DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
|
|---|---|---|
|
Number of Days of Scheduled Blood Loss - Cycle 2
|
4.0 Days
Standard Deviation 2.15
|
2.8 Days
Standard Deviation 2.40
|
PRIMARY outcome
Timeframe: Cycle 3 (Day 78 to 84 for NGM/25mcg EE and day 81 to 84 for DRSP/20mcg EE)Population: Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3.
cycle control between treatment groups, cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.
Outcome measures
| Measure |
NGM/25mcg EE
n=157 Participants
NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
|
DRSP/20mcg EE
n=159 Participants
DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
|
|---|---|---|
|
Number of Days of Scheduled Blood Loss - Cycle 3
|
3.1 Days
Standard Deviation 2.09
|
1.2 Days
Standard Deviation 1.30
|
PRIMARY outcome
Timeframe: Cycle 1 to Cycle 3 (Day 8 to Day 84)Population: Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.
summary of the overall number of days of scheduled blood loss. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.
Outcome measures
| Measure |
NGM/25mcg EE
n=165 Participants
NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
|
DRSP/20mcg EE
n=167 Participants
DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
|
|---|---|---|
|
Overall Number of Days of Scheduled Blood Loss
|
11.2 Days
Standard Deviation 5.40
|
7.0 Days
Standard Deviation 4.80
|
PRIMARY outcome
Timeframe: Cycle 1 (Day 8 to Day 28)Population: Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.
cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.
Outcome measures
| Measure |
NGM/25mcg EE
n=165 Participants
NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
|
DRSP/20mcg EE
n=167 Participants
DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
|
|---|---|---|
|
Number of Days of Total Blood Loss - Cycle 1
|
6.2 Days
Standard Deviation 3.88
|
5.2 Days
Standard Deviation 4.45
|
PRIMARY outcome
Timeframe: Cycle 2 (day 29 to Day 56)Population: Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2.
cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.
Outcome measures
| Measure |
NGM/25mcg EE
n=160 Participants
NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
|
DRSP/20mcg EE
n=165 Participants
DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
|
|---|---|---|
|
Number of Days of Total Blood Loss - Cycle 2
|
5.3 Days
Standard Deviation 2.66
|
4.6 Days
Standard Deviation 3.25
|
PRIMARY outcome
Timeframe: Cycle 3 (Day 57 to Day 84)Population: Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3.
cycle control between treatment groups, cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.
Outcome measures
| Measure |
NGM/25mcg EE
n=157 Participants
NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
|
DRSP/20mcg EE
n=159 Participants
DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
|
|---|---|---|
|
Number of Days of Total Blood Loss - Cycle 3
|
4.6 Days
Standard Deviation 2.64
|
3.6 Days
Standard Deviation 3.10
|
PRIMARY outcome
Timeframe: Cycle 1 to 3 (Day 8 to Day 84)Population: Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.
cycle control between treatment groups, overall. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.
Outcome measures
| Measure |
NGM/25mcg EE
n=165 Participants
NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
|
DRSP/20mcg EE
n=167 Participants
DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
|
|---|---|---|
|
Overall Number of Days of Total Blood Loss
|
15.8 Days
Standard Deviation 6.58
|
13.2 Days
Standard Deviation 6.90
|
PRIMARY outcome
Timeframe: Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)Population: Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.
Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.
Outcome measures
| Measure |
NGM/25mcg EE
n=165 Participants
NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
|
DRSP/20mcg EE
n=167 Participants
DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
|
|---|---|---|
|
Number of Participants With Unscheduled Bleeding Cycle 1
|
72 Participants
|
74 Participants
|
PRIMARY outcome
Timeframe: Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)Population: Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2.
Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.
Outcome measures
| Measure |
NGM/25mcg EE
n=160 Participants
NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
|
DRSP/20mcg EE
n=165 Participants
DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
|
|---|---|---|
|
Number of Participants With Unscheduled Bleeding Cycle 2
|
57 Participants
|
87 Participants
|
PRIMARY outcome
Timeframe: Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)Population: Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3.
Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.
Outcome measures
| Measure |
NGM/25mcg EE
n=157 Participants
NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
|
DRSP/20mcg EE
n=159 Participants
DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
|
|---|---|---|
|
Number of Participants With Unscheduled Bleeding Cycle 3
|
65 Participants
|
94 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)Population: Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.
Breakthrough bleeding/spotting is any bleeding or spotting during active pills excluding days contiguous with withdrawal bleeding or continual withdrawal bleeding.
Outcome measures
| Measure |
NGM/25mcg EE
n=165 Participants
NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
|
DRSP/20mcg EE
n=167 Participants
DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
|
|---|---|---|
|
Number of Participants With Breakthrough Bleeding/Spotting Cycle 1
|
53 Participants
|
56 Participants
|
PRIMARY outcome
Timeframe: Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)Population: Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2.
Breakthrough bleeding/spotting is any bleeding or spotting during active pills excluding days contiguous with withdrawal bleeding or continual withdrawal bleeding.
Outcome measures
| Measure |
NGM/25mcg EE
n=160 Participants
NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
|
DRSP/20mcg EE
n=165 Participants
DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
|
|---|---|---|
|
Number of Participants With Breakthrough Bleeding/Spotting Cycle 2
|
39 Participants
|
62 Participants
|
PRIMARY outcome
Timeframe: Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)Population: Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3.
Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.
Outcome measures
| Measure |
NGM/25mcg EE
n=157 Participants
NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
|
DRSP/20mcg EE
n=159 Participants
DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
|
|---|---|---|
|
Number of Participants With Breakthrough Bleeding/Spotting Cycle 3
|
47 Participants
|
74 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 to Cycle 3Population: Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.
patient satisfaction based on 5 questions during three 28-day cycles - Question 1 (Overall Satisfaction). On a scale of 1 to 5 where 1=Very satisfied and 5=Very dissatisfied.
Outcome measures
| Measure |
NGM/25mcg EE
n=165 Participants
NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
|
DRSP/20mcg EE
n=167 Participants
DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
|
|---|---|---|
|
Patient Satisfaction - Overall
Number of responses
|
159 Participants
|
162 Participants
|
|
Patient Satisfaction - Overall
1. Very Satisfied
|
99 Participants
|
115 Participants
|
|
Patient Satisfaction - Overall
2. Somewhat satisfied
|
35 Participants
|
32 Participants
|
|
Patient Satisfaction - Overall
3. Neither satisfied or dissatisfied
|
12 Participants
|
6 Participants
|
|
Patient Satisfaction - Overall
4. Dissatisfied
|
11 Participants
|
8 Participants
|
|
Patient Satisfaction - Overall
5. Very dissatisfied
|
2 Participants
|
1 Participants
|
Adverse Events
NGM/25mcg EE
Serious events: 2 serious events
Other events: 34 other events
Deaths: 0 deaths
DRSP/20mcg EE
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NGM/25mcg EE
n=167 participants at risk
NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
|
DRSP/20mcg EE
n=167 participants at risk
DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Reproductive system and breast disorders
Pelvic hemorrhage
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
Other adverse events
| Measure |
NGM/25mcg EE
n=167 participants at risk
NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
|
DRSP/20mcg EE
n=167 participants at risk
DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
1.8%
3/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
1.2%
2/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Reproductive system and breast disorders
Breast tenderness
|
1.2%
2/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Reproductive system and breast disorders
Breast enlargement
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Infections and infestations
Bronchitis
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
General disorders
Chest pain
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
1.2%
2/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
General disorders
Fatigue
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Infections and infestations
Gastroenteritis viral
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Infections and infestations
Genital herpes
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Nervous system disorders
Headache
|
1.2%
2/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
1.2%
2/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
General disorders
Irritability
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
2.4%
4/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Surgical and medical procedures
Liposuction
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Infections and infestations
Localised infection
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Psychiatric disorders
Mood swings
|
1.8%
3/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
3.0%
5/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Nervous system disorders
Migraine
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Psychiatric disorders
Mood altered
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Gastrointestinal disorders
Nausea
|
2.4%
4/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Infections and infestations
Pharyngitis streptococcal
|
1.8%
3/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Cardiac disorders
Palpitations
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Psychiatric disorders
Panic disorder
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Reproductive system and breast disorders
Pelvic hemorrhage
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Infections and infestations
Sinusitis
|
1.8%
3/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Nervous system disorders
Tension headache
|
1.2%
2/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Infections and infestations
Urinary tract infection
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Reproductive system and breast disorders
Vaginal cyst
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Eye disorders
Vision blurred
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Gastrointestinal disorders
Vomiting
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Infections and infestations
Vulval abscess
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
0.00%
0/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
|
Investigations
Weight increased
|
0.60%
1/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
1.2%
2/167 • 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups.
|
Additional Information
Chief Scientific Officer
North America Pharmaceutical (Ortho-McNeil Janssen Scientific Affairs, LLC)
Phone: 1-888-526-5060
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60