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An Efficacy and Safety Study Comparing Oral Contraceptive Containing Norgestimate or Desogestrel for Acne Treatment

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ClinicalTrials.gov Identifier: NCT01466673
Recruitment Status : Completed
First Posted : November 8, 2011
Results First Posted : June 19, 2013
Last Update Posted : June 19, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Ltd.,Thailand

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Ethinyl estradiol/Norgestimate (EE/NGM)
Drug: Ethinyl estradiol/Desogestrel (EE/DSG)
Enrollment 201
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ethinyl Estradiol/Norgestimate (EE/NGM) Ethinyl Estradiol/Desogestrel (EE/DSG)
Hide Arm/Group Description 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 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.
Period Title: Overall Study
Started 100 101
Completed 93 95
Not Completed 7 6
Reason Not Completed
Non-compliance with study treatment             2             0
Lost to Follow-up             3             5
Adverse Event             2             1
Arm/Group Title Ethinyl Estradiol/Norgestimate (EE/NGM) Ethinyl Estradiol/Desogestrel (EE/DSG) Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 100 101 201
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 100 participants 101 participants 201 participants
Less than and equal to 18 years 0 0 0
Between 18 and 45 years 100 101 201
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 101 participants 201 participants
Female
100
 100.0%
101
 100.0%
201
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1
Hide Description 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.
Time Frame Baseline and Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ethinyl Estradiol/Norgestimate (EE/NGM) Ethinyl Estradiol/Desogestrel (EE/DSG)
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 100 101
Mean (Standard Deviation)
Unit of Measure: Lesions
Comedones Counts: Baseline 10.97  (6.45) 11.43  (7.58)
Papules Counts: Baseline 4.32  (4.94) 4.46  (5.06)
Pustules Counts: Baseline 0.90  (1.96) 1.12  (2.26)
Nodules Counts: Baseline 0.12  (0.86) 0.00  (0.00)
Total Counts: Baseline 16.31  (9.57) 17.00  (10.41)
Comedones Counts: Change at Month 1 3.43  (4.82) 3.44  (5.31)
Papules Counts: Change at Month 1 0.20  (3.73) 0.62  (2.19)
Pustules Counts: Change at Month 1 0.35  (0.96) 0.18  (0.82)
Nodules Counts: Change at Month 1 0.12  (0.86) -0.02  (0.20)
Total Counts: Change at Month 1 4.10  (4.89) 4.22  (5.91)
2.Primary Outcome
Title Change From Baseline in Total and Each Type of Acne Lesions Count at Month 3
Hide Description 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.
Time Frame Baseline and Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ethinyl Estradiol/Norgestimate (EE/NGM) Ethinyl Estradiol/Desogestrel (EE/DSG)
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 100 101
Mean (Standard Deviation)
Unit of Measure: Lesions
Comedones Counts: Change at Month 3 (n=93, 96) 5.71  (6.93) 5.60  (6.70)
Papules Counts: Change at Month 3 (n=93, 96) 2.83  (3.80) 1.89  (2.92)
Pustules Counts: Change at Month 3 (n=93, 96) 0.63  (1.58) 0.70  (1.50)
Nodules Counts: Change at Month 3 (n=93, 96) 0.12  (0.90) 0.00  (0.00)
Total Counts: Change at Month 3 (n=93, 96) 8.84  (8.13) 8.19  (7.78)
3.Primary Outcome
Title Change From Baseline in Total and Each Type of Acne Lesions Count at Month 6
Hide Description 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.
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ethinyl Estradiol/Norgestimate (EE/NGM) Ethinyl Estradiol/Desogestrel (EE/DSG)
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 100 101
Mean (Standard Deviation)
Unit of Measure: Lesions
Comedones Counts: Change at Month 6 (n=93, 95) 9.02  (6.30) 8.21  (7.43)
Papules Counts: Change at Month 6 (n=93, 95) 3.52  (5.08) 2.77  (4.62)
Pustules Counts: Change at Month 6 (n=93, 95) 0.77  (2.17) 0.96  (2.12)
Nodules Counts: Change at Month 6 (n=93, 95) 0.13  (0.89) 0.00  (0.00)
Total Counts: Change at Month 6 (n=93, 95) 13.44  (9.74) 11.94  (10.08)
4.Secondary Outcome
Title Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6
Hide Description 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.
Time Frame Month 1, 3 and 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ethinyl Estradiol/Norgestimate (EE/NGM) Ethinyl Estradiol/Desogestrel (EE/DSG)
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 100 101
Measure Type: Number
Unit of Measure: Participants
Spotting at Month 1 (n=100,101) 5 2
Spotting at Month 3 (n=93, 96) 6 4
Spotting at Month 6 (n=93, 95) 4 3
Bleeding at Month 1 (n=100,101) 13 4
Bleeding at Month 3 (n=93, 96) 4 7
Bleeding at Month 6 (n=93, 95) 6 3
5.Secondary Outcome
Title Number of Participants Non-Compliant With Therapy
Hide Description 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.
Time Frame Month 1, 3 and 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ethinyl Estradiol/Norgestimate (EE/NGM) Ethinyl Estradiol/Desogestrel (EE/DSG)
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 100 101
Measure Type: Number
Unit of Measure: Participants
At Month 1 (n=100, 101) 7 5
At Month 3 (n=93, 96) 13 10
At Month 6 (n=93, 95) 10 6
6.Secondary Outcome
Title Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6
Hide Description 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.
Time Frame Baseline and Month 1, 3 and 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ethinyl Estradiol/Norgestimate (EE/NGM) Ethinyl Estradiol/Desogestrel (EE/DSG)
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 100 101
Measure Type: Number
Unit of Measure: Percentage of Participants
Level 1: Baseline (n=100,101) 3.00 3.96
Level 2: Baseline (n=100,101) 10.00 12.87
Level 3: Baseline (n=100,101) 43.00 44.55
Level 4: Baseline (n=100,101) 31.00 34.65
Level 5: Baseline (n=100,101) 13.00 3.96
Level 1: Month 1 (n=100,101) 7.00 8.91
Level 2: Month 1 (n=100,101) 13.00 11.88
Level 3: Month 1 (n=100,101) 47.00 45.54
Level 4: Month 1 (n=100,101) 30.00 32.67
Level 5: Month 1 (n=100,101) 3.00 0.99
Level 1: Month 3 (n=93, 96) 6.45 10.42
Level 2: Month 3 (n=93, 96) 34.41 14.58
Level 3: Month 3 (n=93, 96) 45.16 59.38
Level 4: Month 3 (n=93, 96) 11.83 14.58
Level 5: Month 3 (n=93, 96) 2.15 1.04
Level 1: Month 6 (n=93, 95) 44.09 22.11
Level 2: Month 6 (n=93, 95) 27.96 43.16
Level 3: Month 6 (n=93, 95) 20.43 29.47
Level 4: Month 6 (n=93, 95) 6.45 5.26
Level 5: Month 6 (n=93, 95) 1.08 0.00
7.Secondary Outcome
Title Percentage of Participants Showing Treatment Response on the Investigator's Global Assessment at Month 6
Hide Description 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.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ethinyl Estradiol/Norgestimate (EE/NGM) Ethinyl Estradiol/Desogestrel (EE/DSG)
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 93 95
Measure Type: Number
Unit of Measure: Percentage of participants
0 (Worse) 5.05 1.03
1 (No Change) 4.04 1.03
2 (Fair) 4.04 23.71
3 (Good) 43.43 52.58
4 (Excellent) 43.43 21.65
8.Secondary Outcome
Title Number of Participants With Treatment Response at the End-of-Therapy by Participant's Self-Assessment at Month 6
Hide Description 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.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ethinyl Estradiol/Norgestimate (EE/NGM) Ethinyl Estradiol/Desogestrel (EE/DSG)
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 93 95
Measure Type: Number
Unit of Measure: Participants
Excellent 47 35
Better 45 58
No Change 3 3
Worse 4 1
9.Secondary Outcome
Title Change From Baseline in Blood Pressure (BP) at Month 6
Hide Description 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.
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ethinyl Estradiol/Norgestimate (EE/NGM) Ethinyl Estradiol/Desogestrel (EE/DSG)
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 100 101
Mean (Standard Deviation)
Unit of Measure: Millimeters of Mercury
Systolic BP: Baseline (n=100/101) 110.6  (9.93) 110.2  (10.61)
Diastolic BP: Baseline (n=100/101) 70.23  (8.08) 69.47  (8.54)
Systolic BP: Change at Month 6 (n=93, 95) 0.33  (6.77) -0.24  (8.98)
Diastolic BP: Change at Month 6 (n=93, 95) -0.80  (6.69) -0.48  (7.76)
10.Secondary Outcome
Title Change From Baseline in Body Weight at Month 6
Hide Description Change from Baseline in body weight is the value at Month 6 minus value at Baseline.
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ethinyl Estradiol/Norgestimate (EE/NGM) Ethinyl Estradiol/Desogestrel (EE/DSG)
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 100 101
Mean (Standard Deviation)
Unit of Measure: Kilograms
Baseline (n=100,101) 55.62  (8.92) 54.24  (9.36)
Change at Month 6 (n=93,95) -0.08  (1.89) -0.20  (2.53)
Time Frame Baseline up to Month 6
Adverse Event Reporting Description 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.
 
Arm/Group Title Ethinyl Estradiol/Norgestimate (EE/NGM) Ethinyl Estradiol/Desogestrel (EE/DSG)
Hide Arm/Group Description 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 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.
All-Cause Mortality
Ethinyl Estradiol/Norgestimate (EE/NGM) Ethinyl Estradiol/Desogestrel (EE/DSG)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Ethinyl Estradiol/Norgestimate (EE/NGM) Ethinyl Estradiol/Desogestrel (EE/DSG)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/100 (2.00%)      0/101 (0.00%)    
Infections and infestations     
Dengue Hemorrhagic fever * 1  1/100 (1.00%)  1 0/101 (0.00%)  0
Nervous system disorders     
Migraine * 1  1/100 (1.00%)  1 0/101 (0.00%)  0
Sudden severe headache * 1  1/100 (1.00%)  1 0/101 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 14.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ethinyl Estradiol/Norgestimate (EE/NGM) Ethinyl Estradiol/Desogestrel (EE/DSG)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/100 (34.00%)      60/101 (59.41%)    
Gastrointestinal disorders     
Nausea * 1  13/100 (13.00%)  27/101 (26.73%) 
Vomiting * 1  1/100 (1.00%)  2/101 (1.98%) 
Flatulence * 1  0/100 (0.00%)  1/101 (0.99%) 
General disorders     
Oedema peripheral * 1  4/100 (4.00%)  0/101 (0.00%) 
Musculoskeletal and connective tissue disorders     
Muscle spasms * 1  0/100 (0.00%)  1/101 (0.99%) 
Nervous system disorders     
Headache * 1  5/100 (5.00%)  10/101 (9.90%) 
Somnolence * 1  3/100 (3.00%)  2/101 (1.98%) 
Dizziness * 1  0/100 (0.00%)  3/101 (2.97%) 
Psychiatric disorders     
Depression * 1  0/100 (0.00%)  1/101 (0.99%) 
Reproductive system and breast disorders     
Breast pain * 1  5/100 (5.00%)  9/101 (8.91%) 
Libido increased * 1  0/100 (0.00%)  2/101 (1.98%) 
Galactorrhoea * 1  1/100 (1.00%)  0/101 (0.00%) 
Skin and subcutaneous tissue disorders     
Acne * 1  2/100 (2.00%)  2/101 (1.98%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 14.0
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.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Affairs Director
Organization: Medical Affairs, Janssen-Cilag (Thailand)
Phone: 662-739-7200 ext 5888
Layout table for additonal information
Responsible Party: Janssen-Cilag Ltd.,Thailand
ClinicalTrials.gov Identifier: NCT01466673    
Other Study ID Numbers: CR015448
NRGMONCON4003
First Submitted: October 24, 2011
First Posted: November 8, 2011
Results First Submitted: February 22, 2013
Results First Posted: June 19, 2013
Last Update Posted: June 19, 2013