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Study to Evaluate Cycle Control With Norgestimate/Ethinyl Estradiol and Drospirenone/Ethinyl Estradiol in Healthy Sexually Active Females

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00745901
Recruitment Status : Completed
First Posted : September 3, 2008
Results First Posted : May 25, 2010
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Ortho-McNeil Janssen Scientific Affairs, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Contraception
Intervention Drug: Norgestimate/ethinyl estradiol; Drospirenone/ethinyl estradiol
Enrollment 355
Recruitment Details  
Pre-assignment Details  
Arm/Group Title NGM/25mcg EE DRSP/20mcg EE
Hide Arm/Group Description 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=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
Period Title: Overall Study
Started 178 [1] 177 [1]
Completed 154 156
Not Completed 24 21
Reason Not Completed
Adverse Event             3             4
Protocol Violation             0             1
Withdrawal by Subject             1             0
Lost to Follow-up             7             4
Pregnancy             2             4
Lack of compliance             2             2
Patient's next menses did not start with             1             0
Results of Pap smear at Vis 1 malignant             0             2
Chlamydia test at Visit 1 was positive             1             1
Patient didn't take any study medication             7             3
[1]
Number of Patients Randomized
Arm/Group Title NGM/25mcg EE DRSP/20mcg EE Total
Hide Arm/Group Description 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=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients Total of all reporting groups
Overall Number of Baseline Participants 178 177 355
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 178 participants 177 participants 355 participants
<18 years 0 0 0
>= 18 and < 65 years 178 177 355
>=65 years 0 0 0
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 178 participants 177 participants 355 participants
27.2  (6.70) 27.2  (6.52) 27.2  (6.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 178 participants 177 participants 355 participants
Female
178
 100.0%
177
 100.0%
355
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Days of Unscheduled Blood Loss - Cycle 1
Hide Description 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.
Time Frame Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.
Arm/Group Title NGM/25mcg EE DRSP/20mcg EE
Hide Arm/Group Description:
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=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
Overall Number of Participants Analyzed 165 167
Mean (Standard Deviation)
Unit of Measure: Days
1.9  (3.14) 2.0  (3.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NGM/25mcg EE, DRSP/20mcg EE
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9698
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Number of Days of Unscheduled Blood Loss - Cycle 2
Hide Description 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.
Time Frame Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title NGM/25mcg EE DRSP/20mcg EE
Hide Arm/Group Description:
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=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
Overall Number of Participants Analyzed 160 165
Mean (Standard Deviation)
Unit of Measure: Days
1.3  (2.49) 1.9  (2.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NGM/25mcg EE, DRSP/20mcg EE
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0050
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Primary Outcome
Title Number of Days of Unscheduled Blood Loss - Cycle 3
Hide Description 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.
Time Frame Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title NGM/25mcg EE DRSP/20mcg EE
Hide Arm/Group Description:
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=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
Overall Number of Participants Analyzed 157 159
Mean (Standard Deviation)
Unit of Measure: Days
1.4  (2.33) 2.4  (2.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NGM/25mcg EE, DRSP/20mcg EE
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Primary Outcome
Title Overall Number of Days of Unscheduled Blood Loss
Hide Description 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.
Time Frame Cycle 1 to Cycle 3 (Day 8 to Day 80)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.
Arm/Group Title NGM/25mcg EE DRSP/20mcg EE
Hide Arm/Group Description:
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=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
Overall Number of Participants Analyzed 165 167
Mean (Standard Deviation)
Unit of Measure: Days
4.6  (5.33) 6.1  (6.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NGM/25mcg EE, DRSP/20mcg EE
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0031
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Primary Outcome
Title Number of Participants With the Indicated Number of Unscheduled Blood Loss Episodes
Hide Description Unscheduled blood loss episodes are bounded on both sides by at least 1 non- bleeding day.
Time Frame Cycle 1 to Cycle 3 (Day 8 to Day 80)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.
Arm/Group Title NGM/25mcg EE DRSP/20mcg EE
Hide Arm/Group Description:
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=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
Overall Number of Participants Analyzed 165 167
Measure Type: Number
Unit of Measure: Participants
0 Episode 55 29
1 Episode 46 41
2 Episodes 23 50
3 Episodes 21 22
4 Episodes 13 11
5 Episodes 7 8
6 Episodes 0 2
8 Episodes 0 3
9 Episodes 0 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NGM/25mcg EE, DRSP/20mcg EE
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0013
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Primary Outcome
Title Number of Days of Scheduled Blood Loss - Cycle 1
Hide Description 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.
Time Frame Cycle 1 (Day 22 to 32 for NGM/25mcg EE and day 25 to 32 for DRSP/20mcg EE)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.
Arm/Group Title NGM/25mcg EE DRSP/20mcg EE
Hide Arm/Group Description:
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=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
Overall Number of Participants Analyzed 165 167
Mean (Standard Deviation)
Unit of Measure: Days
4.3  (2.09) 3.2  (2.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NGM/25mcg EE, DRSP/20mcg EE
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Primary Outcome
Title Number of Days of Scheduled Blood Loss – Cycle 2
Hide Description 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.
Time Frame Cycle 2 (Day 50 to 60 for NGM/25mcg EE and day 53 to 60 for DRSP/20mcg EE)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title NGM/25mcg EE DRSP/20mcg EE
Hide Arm/Group Description:
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=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
Overall Number of Participants Analyzed 160 165
Mean (Standard Deviation)
Unit of Measure: Days
4.0  (2.15) 2.8  (2.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NGM/25mcg EE, DRSP/20mcg EE
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
8.Primary Outcome
Title Number of Days of Scheduled Blood Loss – Cycle 3
Hide Description 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.
Time Frame Cycle 3 (Day 78 to 84 for NGM/25mcg EE and day 81 to 84 for DRSP/20mcg EE)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title NGM/25mcg EE DRSP/20mcg EE
Hide Arm/Group Description:
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=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
Overall Number of Participants Analyzed 157 159
Mean (Standard Deviation)
Unit of Measure: Days
3.1  (2.09) 1.2  (1.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NGM/25mcg EE, DRSP/20mcg EE
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Primary Outcome
Title Overall Number of Days of Scheduled Blood Loss
Hide Description 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.
Time Frame Cycle 1 to Cycle 3 (Day 8 to Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.
Arm/Group Title NGM/25mcg EE DRSP/20mcg EE
Hide Arm/Group Description:
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=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
Overall Number of Participants Analyzed 165 167
Mean (Standard Deviation)
Unit of Measure: Days
11.2  (5.40) 7.0  (4.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NGM/25mcg EE, DRSP/20mcg EE
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
10.Primary Outcome
Title Number of Days of Total Blood Loss – Cycle 1
Hide Description 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.
Time Frame Cycle 1 (Day 8 to Day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.
Arm/Group Title NGM/25mcg EE DRSP/20mcg EE
Hide Arm/Group Description:
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=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
Overall Number of Participants Analyzed 165 167
Mean (Standard Deviation)
Unit of Measure: Days
6.2  (3.88) 5.2  (4.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NGM/25mcg EE, DRSP/20mcg EE
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0033
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
11.Primary Outcome
Title Number of Days of Total Blood Loss – Cycle 2
Hide Description 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.
Time Frame Cycle 2 (day 29 to Day 56)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title NGM/25mcg EE DRSP/20mcg EE
Hide Arm/Group Description:
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=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
Overall Number of Participants Analyzed 160 165
Mean (Standard Deviation)
Unit of Measure: Days
5.3  (2.66) 4.6  (3.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NGM/25mcg EE, DRSP/20mcg EE
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0060
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
12.Primary Outcome
Title Number of Days of Total Blood Loss – Cycle 3
Hide Description 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.
Time Frame Cycle 3 (Day 57 to Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title NGM/25mcg EE DRSP/20mcg EE
Hide Arm/Group Description:
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=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
Overall Number of Participants Analyzed 157 159
Mean (Standard Deviation)
Unit of Measure: Days
4.6  (2.64) 3.6  (3.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NGM/25mcg EE, DRSP/20mcg EE
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
13.Primary Outcome
Title Overall Number of Days of Total Blood Loss
Hide Description 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.
Time Frame Cycle 1 to 3 (Day 8 to Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.
Arm/Group Title NGM/25mcg EE DRSP/20mcg EE
Hide Arm/Group Description:
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=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
Overall Number of Participants Analyzed 165 167
Mean (Standard Deviation)
Unit of Measure: Days
15.8  (6.58) 13.2  (6.90)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NGM/25mcg EE, DRSP/20mcg EE
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
14.Primary Outcome
Title Number of Participants With Unscheduled Bleeding Cycle 1
Hide Description 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.
Time Frame Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.
Arm/Group Title NGM/25mcg EE DRSP/20mcg EE
Hide Arm/Group Description:
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=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
Overall Number of Participants Analyzed 165 167
Measure Type: Number
Unit of Measure: Participants
72 74
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NGM/25mcg EE, DRSP/20mcg EE
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.912
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
15.Primary Outcome
Title Number of Participants With Unscheduled Bleeding Cycle 2
Hide Description 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.
Time Frame Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title NGM/25mcg EE DRSP/20mcg EE
Hide Arm/Group Description:
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=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
Overall Number of Participants Analyzed 160 165
Measure Type: Number
Unit of Measure: Participants
57 87
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NGM/25mcg EE, DRSP/20mcg EE
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
16.Primary Outcome
Title Number of Participants With Unscheduled Bleeding Cycle 3
Hide Description 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.
Time Frame Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title NGM/25mcg EE DRSP/20mcg EE
Hide Arm/Group Description:
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=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
Overall Number of Participants Analyzed 157 159
Measure Type: Number
Unit of Measure: Participants
65 94
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NGM/25mcg EE, DRSP/20mcg EE
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
17.Primary Outcome
Title Number of Participants With Breakthrough Bleeding/Spotting Cycle 1
Hide Description Breakthrough bleeding/spotting is any bleeding or spotting during active pills excluding days contiguous with withdrawal bleeding or continual withdrawal bleeding.
Time Frame Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.
Arm/Group Title NGM/25mcg EE DRSP/20mcg EE
Hide Arm/Group Description:
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=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
Overall Number of Participants Analyzed 165 167
Measure Type: Number
Unit of Measure: Participants
53 56
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NGM/25mcg EE, DRSP/20mcg EE
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.816
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
18.Primary Outcome
Title Number of Participants With Breakthrough Bleeding/Spotting Cycle 2
Hide Description Breakthrough bleeding/spotting is any bleeding or spotting during active pills excluding days contiguous with withdrawal bleeding or continual withdrawal bleeding.
Time Frame Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title NGM/25mcg EE DRSP/20mcg EE
Hide Arm/Group Description:
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=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
Overall Number of Participants Analyzed 160 165
Measure Type: Number
Unit of Measure: Participants
39 62
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NGM/25mcg EE, DRSP/20mcg EE
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
19.Primary Outcome
Title Number of Participants With Breakthrough Bleeding/Spotting Cycle 3
Hide Description 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.
Time Frame Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title NGM/25mcg EE DRSP/20mcg EE
Hide Arm/Group Description:
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=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
Overall Number of Participants Analyzed 157 159
Measure Type: Number
Unit of Measure: Participants
47 74
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NGM/25mcg EE, DRSP/20mcg EE
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
20.Secondary Outcome
Title Patient Satisfaction - Overall
Hide Description 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.
Time Frame Cycle 1 to Cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.
Arm/Group Title NGM/25mcg EE DRSP/20mcg EE
Hide Arm/Group Description:
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=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
Overall Number of Participants Analyzed 165 167
Measure Type: Number
Unit of Measure: Participants
Number of responses 159 162
1. Very Satisfied 99 115
2. Somewhat satisfied 35 32
3. Neither satisfied or dissatisfied 12 6
4. Dissatisfied 11 8
5. Very dissatisfied 2 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NGM/25mcg EE, DRSP/20mcg EE
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0715
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Adverse Event Reporting Description 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.
 
Arm/Group Title NGM/25mcg EE DRSP/20mcg EE
Hide Arm/Group Description 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=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
All-Cause Mortality
NGM/25mcg EE DRSP/20mcg EE
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
NGM/25mcg EE DRSP/20mcg EE
Affected / at Risk (%) Affected / at Risk (%)
Total   2/167 (1.20%)   1/167 (0.60%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  1  1/167 (0.60%)  0/167 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Uterine leiomyoma  1  1/167 (0.60%)  0/167 (0.00%) 
Reproductive system and breast disorders     
Ovarian cyst ruptured  1  1/167 (0.60%)  0/167 (0.00%) 
Pelvic hemorrhage  1  1/167 (0.60%)  0/167 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  0/167 (0.00%)  1/167 (0.60%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
NGM/25mcg EE DRSP/20mcg EE
Affected / at Risk (%) Affected / at Risk (%)
Total   34/167 (20.36%)   34/167 (20.36%) 
Cardiac disorders     
Palpitations  1  1/167 (0.60%)  0/167 (0.00%) 
Endocrine disorders     
Hypothyroidism  1  0/167 (0.00%)  1/167 (0.60%) 
Eye disorders     
Vision blurred  1  0/167 (0.00%)  1/167 (0.60%) 
Gastrointestinal disorders     
Abdominal distension  1  1/167 (0.60%)  0/167 (0.00%) 
Nausea  1  4/167 (2.40%)  1/167 (0.60%) 
Vomiting  1  1/167 (0.60%)  1/167 (0.60%) 
General disorders     
Chest pain  1  1/167 (0.60%)  0/167 (0.00%) 
Fatigue  1  0/167 (0.00%)  1/167 (0.60%) 
Irritability  1  1/167 (0.60%)  4/167 (2.40%) 
Infections and infestations     
Bronchitis  1  1/167 (0.60%)  0/167 (0.00%) 
Gastroenteritis viral  1  1/167 (0.60%)  1/167 (0.60%) 
Genital herpes  1  1/167 (0.60%)  0/167 (0.00%) 
Localised infection  1  1/167 (0.60%)  0/167 (0.00%) 
Pharyngitis streptococcal  1  3/167 (1.80%)  0/167 (0.00%) 
Periorbital cellulitis  1  0/167 (0.00%)  1/167 (0.60%) 
Sinusitis  1  3/167 (1.80%)  0/167 (0.00%) 
Upper respiratory tract infection  1  0/167 (0.00%)  1/167 (0.60%) 
Urinary tract infection  1  1/167 (0.60%)  0/167 (0.00%) 
Vulval abscess  1  1/167 (0.60%)  0/167 (0.00%) 
Injury, poisoning and procedural complications     
Joint sprain  1  0/167 (0.00%)  1/167 (0.60%) 
Limb injury  1  0/167 (0.00%)  1/167 (0.60%) 
Sunburn  1  1/167 (0.60%)  0/167 (0.00%) 
Investigations     
Weight increased  1  1/167 (0.60%)  2/167 (1.20%) 
Metabolism and nutrition disorders     
Fluid retention  1  0/167 (0.00%)  1/167 (0.60%) 
Polydipsia  1  0/167 (0.00%)  1/167 (0.60%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/167 (0.60%)  2/167 (1.20%) 
Intervertebral disc protrusion  1  1/167 (0.60%)  0/167 (0.00%) 
Muscle spasms  1  0/167 (0.00%)  1/167 (0.60%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Uterine leiomyoma  1  1/167 (0.60%)  0/167 (0.00%) 
Nervous system disorders     
Headache  1  2/167 (1.20%)  2/167 (1.20%) 
Migraine  1  0/167 (0.00%)  1/167 (0.60%) 
Sinus headache  1  0/167 (0.00%)  1/167 (0.60%) 
Tension headache  1  2/167 (1.20%)  1/167 (0.60%) 
Pregnancy, puerperium and perinatal conditions     
Pregnancy  1  1/167 (0.60%)  0/167 (0.00%) 
Psychiatric disorders     
Anxiety disorder  1  0/167 (0.00%)  1/167 (0.60%) 
Libido decreased  1  0/167 (0.00%)  1/167 (0.60%) 
Mood swings  1  3/167 (1.80%)  5/167 (2.99%) 
Mood altered  1  1/167 (0.60%)  0/167 (0.00%) 
Panic disorder  1  0/167 (0.00%)  1/167 (0.60%) 
Reproductive system and breast disorders     
Breast tenderness  1  2/167 (1.20%)  0/167 (0.00%) 
Breast enlargement  1  1/167 (0.60%)  0/167 (0.00%) 
Dysmenorrhea  1  0/167 (0.00%)  2/167 (1.20%) 
Ovarian cyst ruptured  1  1/167 (0.60%)  0/167 (0.00%) 
Pelvic hemorrhage  1  1/167 (0.60%)  0/167 (0.00%) 
Pelvic pain  1  0/167 (0.00%)  1/167 (0.60%) 
Vaginal cyst  1  0/167 (0.00%)  1/167 (0.60%) 
Vaginal hemorrhage  1  1/167 (0.60%)  0/167 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  0/167 (0.00%)  1/167 (0.60%) 
Rhinitis allergic  1  0/167 (0.00%)  1/167 (0.60%) 
Rhinorrhea  1  1/167 (0.60%)  0/167 (0.00%) 
Skin and subcutaneous tissue disorders     
Acne  1  0/167 (0.00%)  3/167 (1.80%) 
Dermatitis allergic  1  1/167 (0.60%)  0/167 (0.00%) 
Dermatitis contact  1  0/167 (0.00%)  1/167 (0.60%) 
Pruritus  1  0/167 (0.00%)  1/167 (0.60%) 
Urticaria  1  0/167 (0.00%)  1/167 (0.60%) 
Surgical and medical procedures     
Liposuction  1  1/167 (0.60%)  0/167 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Scientific Officer
Organization: North America Pharmaceutical (Ortho-McNeil Janssen Scientific Affairs, LLC)
Phone: 1-888-526-5060 ext 2915
Layout table for additonal information
Responsible Party: Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT00745901     History of Changes
Other Study ID Numbers: CR015055
First Submitted: September 2, 2008
First Posted: September 3, 2008
Results First Submitted: April 22, 2010
Results First Posted: May 25, 2010
Last Update Posted: March 19, 2019