Trial Outcomes & Findings for An Efficacy and Safety Study Comparing Oral Contraceptive Containing Norgestimate or Desogestrel for Acne Treatment (NCT NCT01466673)
NCT ID: NCT01466673
Last Updated: 2013-06-19
Results Overview
Total acne (pimples) lesion (abnormal area of tissue, such as a wound, sore, rash, or boil) count is summation of all lesions which includes all comedones (open and closed), papules, pustules, and nodules. Change from Baseline means lesions at Baseline minus lesions at Month 1. Positive value indicates decrease in lesion count while negative value indicates increase in lesion count.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
201 participants
Primary outcome timeframe
Baseline and Month 1
Results posted on
2013-06-19
Participant Flow
Participant milestones
| Measure |
Ethinyl Estradiol/Norgestimate (EE/NGM)
Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
|
Ethinyl Estradiol/Desogestrel (EE/DSG)
Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
101
|
|
Overall Study
COMPLETED
|
93
|
95
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
| Measure |
Ethinyl Estradiol/Norgestimate (EE/NGM)
Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
|
Ethinyl Estradiol/Desogestrel (EE/DSG)
Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
|
|---|---|---|
|
Overall Study
Non-compliance with study treatment
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
|
Overall Study
Adverse Event
|
2
|
1
|
Baseline Characteristics
An Efficacy and Safety Study Comparing Oral Contraceptive Containing Norgestimate or Desogestrel for Acne Treatment
Baseline characteristics by cohort
| Measure |
Ethinyl Estradiol/Norgestimate (EE/NGM)
n=100 Participants
Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
|
Ethinyl Estradiol/Desogestrel (EE/DSG)
n=101 Participants
Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Less than and equal to 18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Customized
Between 18 and 45 years
|
100 Participants
n=39 Participants
|
101 Participants
n=41 Participants
|
201 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=39 Participants
|
101 Participants
n=41 Participants
|
201 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 1Population: Intent-to-treat population (ITT) included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria.
Total acne (pimples) lesion (abnormal area of tissue, such as a wound, sore, rash, or boil) count is summation of all lesions which includes all comedones (open and closed), papules, pustules, and nodules. Change from Baseline means lesions at Baseline minus lesions at Month 1. Positive value indicates decrease in lesion count while negative value indicates increase in lesion count.
Outcome measures
| Measure |
Ethinyl Estradiol/Norgestimate (EE/NGM)
n=100 Participants
Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
|
Ethinyl Estradiol/Desogestrel (EE/DSG)
n=101 Participants
Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
|
|---|---|---|
|
Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1
Comedones Counts: Baseline
|
10.97 Lesions
Standard Deviation 6.45
|
11.43 Lesions
Standard Deviation 7.58
|
|
Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1
Papules Counts: Baseline
|
4.32 Lesions
Standard Deviation 4.94
|
4.46 Lesions
Standard Deviation 5.06
|
|
Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1
Pustules Counts: Baseline
|
0.90 Lesions
Standard Deviation 1.96
|
1.12 Lesions
Standard Deviation 2.26
|
|
Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1
Nodules Counts: Baseline
|
0.12 Lesions
Standard Deviation 0.86
|
0.00 Lesions
Standard Deviation 0.00
|
|
Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1
Total Counts: Baseline
|
16.31 Lesions
Standard Deviation 9.57
|
17.00 Lesions
Standard Deviation 10.41
|
|
Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1
Comedones Counts: Change at Month 1
|
3.43 Lesions
Standard Deviation 4.82
|
3.44 Lesions
Standard Deviation 5.31
|
|
Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1
Papules Counts: Change at Month 1
|
0.20 Lesions
Standard Deviation 3.73
|
0.62 Lesions
Standard Deviation 2.19
|
|
Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1
Pustules Counts: Change at Month 1
|
0.35 Lesions
Standard Deviation 0.96
|
0.18 Lesions
Standard Deviation 0.82
|
|
Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1
Nodules Counts: Change at Month 1
|
0.12 Lesions
Standard Deviation 0.86
|
-0.02 Lesions
Standard Deviation 0.20
|
|
Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1
Total Counts: Change at Month 1
|
4.10 Lesions
Standard Deviation 4.89
|
4.22 Lesions
Standard Deviation 5.91
|
PRIMARY outcome
Timeframe: Baseline and Month 3Population: ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. "n" signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.
Total acne (pimples) lesion (abnormal area of tissue, such as a wound, sore, rash, or boil) count is summation of all lesions which includes all comedones (open and closed), papules, pustules, and nodules. Change from Baseline means lesions at Baseline minus lesions at Month 3. Positive value indicates decrease in lesion count while negative value indicates increase in lesion count.
Outcome measures
| Measure |
Ethinyl Estradiol/Norgestimate (EE/NGM)
n=100 Participants
Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
|
Ethinyl Estradiol/Desogestrel (EE/DSG)
n=101 Participants
Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
|
|---|---|---|
|
Change From Baseline in Total and Each Type of Acne Lesions Count at Month 3
Comedones Counts: Change at Month 3 (n=93, 96)
|
5.71 Lesions
Standard Deviation 6.93
|
5.60 Lesions
Standard Deviation 6.70
|
|
Change From Baseline in Total and Each Type of Acne Lesions Count at Month 3
Papules Counts: Change at Month 3 (n=93, 96)
|
2.83 Lesions
Standard Deviation 3.80
|
1.89 Lesions
Standard Deviation 2.92
|
|
Change From Baseline in Total and Each Type of Acne Lesions Count at Month 3
Pustules Counts: Change at Month 3 (n=93, 96)
|
0.63 Lesions
Standard Deviation 1.58
|
0.70 Lesions
Standard Deviation 1.50
|
|
Change From Baseline in Total and Each Type of Acne Lesions Count at Month 3
Nodules Counts: Change at Month 3 (n=93, 96)
|
0.12 Lesions
Standard Deviation 0.90
|
0.00 Lesions
Standard Deviation 0.00
|
|
Change From Baseline in Total and Each Type of Acne Lesions Count at Month 3
Total Counts: Change at Month 3 (n=93, 96)
|
8.84 Lesions
Standard Deviation 8.13
|
8.19 Lesions
Standard Deviation 7.78
|
PRIMARY outcome
Timeframe: Baseline and Month 6Population: ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. "n" signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.
Total acne (pimples) lesion (abnormal area of tissue, such as a wound, sore, rash, or boil) count is summation of all lesions which includes all comedones (open and closed), papules, pustules, and nodules. Change from Baseline means lesions at Baseline minus lesions at Month 6. Positive value indicates decrease in lesion count while negative value indicates increase in lesion count.
Outcome measures
| Measure |
Ethinyl Estradiol/Norgestimate (EE/NGM)
n=100 Participants
Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
|
Ethinyl Estradiol/Desogestrel (EE/DSG)
n=101 Participants
Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
|
|---|---|---|
|
Change From Baseline in Total and Each Type of Acne Lesions Count at Month 6
Comedones Counts: Change at Month 6 (n=93, 95)
|
9.02 Lesions
Standard Deviation 6.30
|
8.21 Lesions
Standard Deviation 7.43
|
|
Change From Baseline in Total and Each Type of Acne Lesions Count at Month 6
Papules Counts: Change at Month 6 (n=93, 95)
|
3.52 Lesions
Standard Deviation 5.08
|
2.77 Lesions
Standard Deviation 4.62
|
|
Change From Baseline in Total and Each Type of Acne Lesions Count at Month 6
Pustules Counts: Change at Month 6 (n=93, 95)
|
0.77 Lesions
Standard Deviation 2.17
|
0.96 Lesions
Standard Deviation 2.12
|
|
Change From Baseline in Total and Each Type of Acne Lesions Count at Month 6
Nodules Counts: Change at Month 6 (n=93, 95)
|
0.13 Lesions
Standard Deviation 0.89
|
0.00 Lesions
Standard Deviation 0.00
|
|
Change From Baseline in Total and Each Type of Acne Lesions Count at Month 6
Total Counts: Change at Month 6 (n=93, 95)
|
13.44 Lesions
Standard Deviation 9.74
|
11.94 Lesions
Standard Deviation 10.08
|
SECONDARY outcome
Timeframe: Month 1, 3 and 6Population: Safety population included all randomized participants who received at least one dose of study medication. "n" signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.
Vaginal blood loss encompasses spotting and bleeding. Spotting is defined as a bleeding requiring no or at most one sanitary pad per day; however, bleeding requires two or more sanitary pads per day.
Outcome measures
| Measure |
Ethinyl Estradiol/Norgestimate (EE/NGM)
n=100 Participants
Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
|
Ethinyl Estradiol/Desogestrel (EE/DSG)
n=101 Participants
Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
|
|---|---|---|
|
Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6
Spotting at Month 1 (n=100,101)
|
5 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6
Spotting at Month 3 (n=93, 96)
|
6 Participants
|
4 Participants
|
|
Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6
Spotting at Month 6 (n=93, 95)
|
4 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6
Bleeding at Month 1 (n=100,101)
|
13 Participants
|
4 Participants
|
|
Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6
Bleeding at Month 3 (n=93, 96)
|
4 Participants
|
7 Participants
|
|
Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6
Bleeding at Month 6 (n=93, 95)
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Month 1, 3 and 6Population: ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. "n" signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.
Compliance was assessed by transforming the data of forgotten tablets listed in the diary cards. Number of participants who forgot to take the drug was reported.
Outcome measures
| Measure |
Ethinyl Estradiol/Norgestimate (EE/NGM)
n=100 Participants
Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
|
Ethinyl Estradiol/Desogestrel (EE/DSG)
n=101 Participants
Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
|
|---|---|---|
|
Number of Participants Non-Compliant With Therapy
At Month 1 (n=100, 101)
|
7 Participants
|
5 Participants
|
|
Number of Participants Non-Compliant With Therapy
At Month 3 (n=93, 96)
|
13 Participants
|
10 Participants
|
|
Number of Participants Non-Compliant With Therapy
At Month 6 (n=93, 95)
|
10 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline and Month 1, 3 and 6Population: ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. "n" signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.
Sebum assessment that is facial seborrhea (very oily skin) was assessed using sebutape strip on the forehead. Percentage of participants with facial seborrhea were assessed using categorical scores ranging from level 1 (lowest) to level 5 (highest). Highest level indicates worsening.
Outcome measures
| Measure |
Ethinyl Estradiol/Norgestimate (EE/NGM)
n=100 Participants
Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
|
Ethinyl Estradiol/Desogestrel (EE/DSG)
n=101 Participants
Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
|
|---|---|---|
|
Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6
Level 1: Month 1 (n=100,101)
|
7.00 Percentage of Participants
|
8.91 Percentage of Participants
|
|
Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6
Level 1: Baseline (n=100,101)
|
3.00 Percentage of Participants
|
3.96 Percentage of Participants
|
|
Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6
Level 2: Baseline (n=100,101)
|
10.00 Percentage of Participants
|
12.87 Percentage of Participants
|
|
Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6
Level 3: Baseline (n=100,101)
|
43.00 Percentage of Participants
|
44.55 Percentage of Participants
|
|
Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6
Level 4: Baseline (n=100,101)
|
31.00 Percentage of Participants
|
34.65 Percentage of Participants
|
|
Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6
Level 5: Baseline (n=100,101)
|
13.00 Percentage of Participants
|
3.96 Percentage of Participants
|
|
Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6
Level 2: Month 1 (n=100,101)
|
13.00 Percentage of Participants
|
11.88 Percentage of Participants
|
|
Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6
Level 3: Month 1 (n=100,101)
|
47.00 Percentage of Participants
|
45.54 Percentage of Participants
|
|
Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6
Level 4: Month 1 (n=100,101)
|
30.00 Percentage of Participants
|
32.67 Percentage of Participants
|
|
Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6
Level 5: Month 1 (n=100,101)
|
3.00 Percentage of Participants
|
0.99 Percentage of Participants
|
|
Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6
Level 1: Month 3 (n=93, 96)
|
6.45 Percentage of Participants
|
10.42 Percentage of Participants
|
|
Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6
Level 2: Month 3 (n=93, 96)
|
34.41 Percentage of Participants
|
14.58 Percentage of Participants
|
|
Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6
Level 3: Month 3 (n=93, 96)
|
45.16 Percentage of Participants
|
59.38 Percentage of Participants
|
|
Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6
Level 4: Month 3 (n=93, 96)
|
11.83 Percentage of Participants
|
14.58 Percentage of Participants
|
|
Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6
Level 5: Month 3 (n=93, 96)
|
2.15 Percentage of Participants
|
1.04 Percentage of Participants
|
|
Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6
Level 1: Month 6 (n=93, 95)
|
44.09 Percentage of Participants
|
22.11 Percentage of Participants
|
|
Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6
Level 2: Month 6 (n=93, 95)
|
27.96 Percentage of Participants
|
43.16 Percentage of Participants
|
|
Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6
Level 3: Month 6 (n=93, 95)
|
20.43 Percentage of Participants
|
29.47 Percentage of Participants
|
|
Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6
Level 4: Month 6 (n=93, 95)
|
6.45 Percentage of Participants
|
5.26 Percentage of Participants
|
|
Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6
Level 5: Month 6 (n=93, 95)
|
1.08 Percentage of Participants
|
0.00 Percentage of Participants
|
SECONDARY outcome
Timeframe: Month 6Population: ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. "N" signifies those participants who were evaluated for this measure.
Percentage of participants showing treatment response on the Investigator's global assessment was graded on a 5-point scale as 0=worse, 1=no change, 2=fair, 3=good, and 4=excellent.
Outcome measures
| Measure |
Ethinyl Estradiol/Norgestimate (EE/NGM)
n=93 Participants
Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
|
Ethinyl Estradiol/Desogestrel (EE/DSG)
n=95 Participants
Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
|
|---|---|---|
|
Percentage of Participants Showing Treatment Response on the Investigator's Global Assessment at Month 6
0 (Worse)
|
5.05 Percentage of participants
|
1.03 Percentage of participants
|
|
Percentage of Participants Showing Treatment Response on the Investigator's Global Assessment at Month 6
1 (No Change)
|
4.04 Percentage of participants
|
1.03 Percentage of participants
|
|
Percentage of Participants Showing Treatment Response on the Investigator's Global Assessment at Month 6
2 (Fair)
|
4.04 Percentage of participants
|
23.71 Percentage of participants
|
|
Percentage of Participants Showing Treatment Response on the Investigator's Global Assessment at Month 6
3 (Good)
|
43.43 Percentage of participants
|
52.58 Percentage of participants
|
|
Percentage of Participants Showing Treatment Response on the Investigator's Global Assessment at Month 6
4 (Excellent)
|
43.43 Percentage of participants
|
21.65 Percentage of participants
|
SECONDARY outcome
Timeframe: Month 6Population: ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. "N" signifies those participants who were evaluated for this measure.
Participant's self-assessment at end-of-therapy was measured by using the self-assessment questionnaire which included 3 questions, about the rating of acne improvement since start of study; comparison of this acne treatment with the one used in past and the continuity of treatment on physician's prescription to evaluate efficacy and acceptability of the study medication. The score was graded at 4 parameters as excellent, better, no change and worse.
Outcome measures
| Measure |
Ethinyl Estradiol/Norgestimate (EE/NGM)
n=93 Participants
Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
|
Ethinyl Estradiol/Desogestrel (EE/DSG)
n=95 Participants
Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
|
|---|---|---|
|
Number of Participants With Treatment Response at the End-of-Therapy by Participant's Self-Assessment at Month 6
Worse
|
4 Participants
|
1 Participants
|
|
Number of Participants With Treatment Response at the End-of-Therapy by Participant's Self-Assessment at Month 6
Excellent
|
47 Participants
|
35 Participants
|
|
Number of Participants With Treatment Response at the End-of-Therapy by Participant's Self-Assessment at Month 6
Better
|
45 Participants
|
58 Participants
|
|
Number of Participants With Treatment Response at the End-of-Therapy by Participant's Self-Assessment at Month 6
No Change
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: Safety population included all randomized participants who received at least one dose of study medication. "n" signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.
Blood pressure is the pressure of blood flowing through blood vessels. Change from Baseline in blood pressure is the value at Month 6 minus value at Baseline.
Outcome measures
| Measure |
Ethinyl Estradiol/Norgestimate (EE/NGM)
n=100 Participants
Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
|
Ethinyl Estradiol/Desogestrel (EE/DSG)
n=101 Participants
Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
|
|---|---|---|
|
Change From Baseline in Blood Pressure (BP) at Month 6
Systolic BP: Baseline (n=100/101)
|
110.6 Millimeters of Mercury
Standard Deviation 9.93
|
110.2 Millimeters of Mercury
Standard Deviation 10.61
|
|
Change From Baseline in Blood Pressure (BP) at Month 6
Diastolic BP: Baseline (n=100/101)
|
70.23 Millimeters of Mercury
Standard Deviation 8.08
|
69.47 Millimeters of Mercury
Standard Deviation 8.54
|
|
Change From Baseline in Blood Pressure (BP) at Month 6
Systolic BP: Change at Month 6 (n=93, 95)
|
0.33 Millimeters of Mercury
Standard Deviation 6.77
|
-0.24 Millimeters of Mercury
Standard Deviation 8.98
|
|
Change From Baseline in Blood Pressure (BP) at Month 6
Diastolic BP: Change at Month 6 (n=93, 95)
|
-0.80 Millimeters of Mercury
Standard Deviation 6.69
|
-0.48 Millimeters of Mercury
Standard Deviation 7.76
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: Safety population included all randomized participants who received at least one dose of study medication. "n" signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.
Change from Baseline in body weight is the value at Month 6 minus value at Baseline.
Outcome measures
| Measure |
Ethinyl Estradiol/Norgestimate (EE/NGM)
n=100 Participants
Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
|
Ethinyl Estradiol/Desogestrel (EE/DSG)
n=101 Participants
Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
|
|---|---|---|
|
Change From Baseline in Body Weight at Month 6
Baseline (n=100,101)
|
55.62 Kilograms
Standard Deviation 8.92
|
54.24 Kilograms
Standard Deviation 9.36
|
|
Change From Baseline in Body Weight at Month 6
Change at Month 6 (n=93,95)
|
-0.08 Kilograms
Standard Deviation 1.89
|
-0.20 Kilograms
Standard Deviation 2.53
|
Adverse Events
Ethinyl Estradiol/Norgestimate (EE/NGM)
Serious events: 2 serious events
Other events: 34 other events
Deaths: 0 deaths
Ethinyl Estradiol/Desogestrel (EE/DSG)
Serious events: 0 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ethinyl Estradiol/Norgestimate (EE/NGM)
n=100 participants at risk
Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
|
Ethinyl Estradiol/Desogestrel (EE/DSG)
n=101 participants at risk
Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
|
|---|---|---|
|
Nervous system disorders
Migraine
|
1.0%
1/100 • Number of events 1 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
0.00%
0/101 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Nervous system disorders
Sudden severe headache
|
1.0%
1/100 • Number of events 1 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
0.00%
0/101 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Infections and infestations
Dengue Hemorrhagic fever
|
1.0%
1/100 • Number of events 1 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
0.00%
0/101 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
Other adverse events
| Measure |
Ethinyl Estradiol/Norgestimate (EE/NGM)
n=100 participants at risk
Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
|
Ethinyl Estradiol/Desogestrel (EE/DSG)
n=101 participants at risk
Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
13.0%
13/100 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
26.7%
27/101 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
1/100 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
2.0%
2/101 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/100 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
0.99%
1/101 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
General disorders
Oedema peripheral
|
4.0%
4/100 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
0.00%
0/101 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/100 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
0.99%
1/101 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Nervous system disorders
Headache
|
5.0%
5/100 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
9.9%
10/101 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Nervous system disorders
Somnolence
|
3.0%
3/100 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
2.0%
2/101 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/100 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
3.0%
3/101 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Psychiatric disorders
Depression
|
0.00%
0/100 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
0.99%
1/101 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Reproductive system and breast disorders
Breast pain
|
5.0%
5/100 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
8.9%
9/101 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Reproductive system and breast disorders
Libido increased
|
0.00%
0/100 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
2.0%
2/101 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Reproductive system and breast disorders
Galactorrhoea
|
1.0%
1/100 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
0.00%
0/101 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.0%
2/100 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
2.0%
2/101 • Baseline up to Month 6
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
Additional Information
Medical Affairs Director
Medical Affairs, Janssen-Cilag (Thailand)
Phone: 662-739-7200
Results disclosure agreements
- Principal investigator is a sponsor employee If Institution \& Principal Investigator wish to publish information from Clinical Trial, a copy of manuscript must be provided to Sponsor at least 60 days prior to submission for publication/presentation and will arrange expedited reviews for the same. No paper with confidential information will be submitted without Sponsor's prior consent. If requested, Institution and Principal Investigator will hold such publication for up to additional 60 days to allow filing of patent application.
- Publication restrictions are in place
Restriction type: OTHER