Acne Vulgaris
Conditions
Keywords
Acne Vulgaris, Ethinyl estradiol, Norgestimate, Desogestrel, Tricilest, Oilezz
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Ethinyl estradiol and Norgestimate (EE/NGM) compared to Ethinyl estradiol and Desogestrel (EE/DSG), for treatment of female participants with mild to moderate acne vulgaris (pimples).
Detailed description
This is a single-blind (physician does not know the name of the assigned drug) and randomized (study drug assigned by chance) study to compare the effectiveness and safety of EE/NGM and EE/DSG in female participants using oral contraceptive and have mild to moderate acne vulgaris. Tablets of EE/NGM and EE/DSG will be administered orally once daily for 6 months and will be instructed to visit for evaluation at Month 1, 3 and 6 post-administration. The efficacy will be evaluated efficacy primarily through total acne lesions count, which will be recorded at these evaluation visits. Unused study medications will be collected and drug accountability will be documented. Participants' safety will be monitored throughout the study.
Interventions
DRUGEthinyl estradiol/Norgestimate (EE/NGM)
Ethinyl estradiol/Norgestimate encapsulated oral tablet will be 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.
DRUGEthinyl estradiol/Desogestrel (EE/DSG)
Ethinyl estradiol/Desogestrel oral formulation will be 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.
Sponsors
Janssen-Cilag Ltd.,Thailand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
- Needs contraception in the family planning - Mild to moderate acne vulgaris - Agrees to take only the supplied study drug as treatment for acne during the 6-month treatment phase of the study - Signs and dates an informed consent to participate in the study - female participants aged 18 to 45 years
Exclusion criteria
- Pregnant or nursing - Known hypersensitivity to any of the ingredients and currently having significant adverse experiences from ethinyl estradiol, norgestimate or desogestrel - Any coexisting medical condition or were taking any concomitant medication that is likely to interfere with safe administration of ethinyl estradiol/norgestimate and ethinyl estradiol/desogestrel, in the Investigator's opinion - Taking system retinoids, systemic antimicrobials, and topical acne treatments within 6 months, 1 month, and 2 weeks prior to enrollment, respectively - Taking investigational medication or oral contraceptives within 30 days prior to Screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1 | Baseline and Month 1 | 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. |
| Change From Baseline in Total and Each Type of Acne Lesions Count at Month 3 | Baseline and Month 3 | 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. |
| Change From Baseline in Total and Each Type of Acne Lesions Count at Month 6 | Baseline and Month 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Showing Treatment Response on the Investigator's Global Assessment at Month 6 | Month 6 | 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. |
| Number of Participants With Treatment Response at the End-of-Therapy by Participant's Self-Assessment at Month 6 | Month 6 | 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. |
| Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6 | Month 1, 3 and 6 | 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. |
| Change From Baseline in Body Weight at Month 6 | Baseline and Month 6 | Change from Baseline in body weight is the value at Month 6 minus value at Baseline. |
| Change From Baseline in Blood Pressure (BP) at Month 6 | Baseline and Month 6 | 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. |
| Number of Participants Non-Compliant With Therapy | Month 1, 3 and 6 | 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. |
| Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6 | Baseline and Month 1, 3 and 6 | 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. |
Countries
Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 100 |
| 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. | 101 |
| Total | 201 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Lost to Follow-up | 3 | 5 |
| Overall Study | Non-compliance with study treatment | 2 | 0 |
Baseline characteristics
| Characteristic | Ethinyl Estradiol/Norgestimate (EE/NGM) | Ethinyl Estradiol/Desogestrel (EE/DSG) | Total |
|---|---|---|---|
| Age, Customized Between 18 and 45 years | 100 Participants | 101 Participants | 201 Participants |
| Age, Customized Less than and equal to 18 years | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 100 Participants | 101 Participants | 201 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 34 / 100 | 60 / 101 |
| serious Total, serious adverse events | 2 / 100 | 0 / 101 |
Outcome results
Primary
Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1 | Pustules Counts: Change at Month 1 | 0.18 Lesions | Standard Deviation 0.82 |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1 | Comedones Counts: Baseline | 11.43 Lesions | Standard Deviation 7.58 |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1 | Comedones Counts: Change at Month 1 | 3.44 Lesions | Standard Deviation 5.31 |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1 | Papules Counts: Baseline | 4.46 Lesions | Standard Deviation 5.06 |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1 | Total Counts: Change at Month 1 | 4.22 Lesions | Standard Deviation 5.91 |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1 | Pustules Counts: Baseline | 1.12 Lesions | Standard Deviation 2.26 |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1 | Papules Counts: Change at Month 1 | 0.62 Lesions | Standard Deviation 2.19 |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1 | Nodules Counts: Baseline | 0.00 Lesions | Standard Deviation 0 |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1 | Nodules Counts: Change at Month 1 | -0.02 Lesions | Standard Deviation 0.2 |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1 | Total Counts: Baseline | 17.00 Lesions | Standard Deviation 10.41 |
Primary
Change From Baseline in Total and Each Type of Acne Lesions Count at Month 3
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 3.8 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 0.9 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Change From Baseline in Total and Each Type of Acne Lesions Count at Month 3 | Total Counts: Change at Month 3 (n=93, 96) | 8.19 Lesions | Standard Deviation 7.78 |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Change From Baseline in Total and Each Type of Acne Lesions Count at Month 3 | Comedones Counts: Change at Month 3 (n=93, 96) | 5.60 Lesions | Standard Deviation 6.7 |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Change From Baseline in Total and Each Type of Acne Lesions Count at Month 3 | Papules Counts: Change at Month 3 (n=93, 96) | 1.89 Lesions | Standard Deviation 2.92 |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Change From Baseline in Total and Each Type of Acne Lesions Count at Month 3 | Pustules Counts: Change at Month 3 (n=93, 96) | 0.70 Lesions | Standard Deviation 1.5 |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Change From Baseline in Total and Each Type of Acne Lesions Count at Month 3 | Nodules Counts: Change at Month 3 (n=93, 96) | 0.00 Lesions | Standard Deviation 0 |
Primary
Change From Baseline in Total and Each Type of Acne Lesions Count at Month 6
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 6.3 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Change From Baseline in Total and Each Type of Acne Lesions Count at Month 6 | Total Counts: Change at Month 6 (n=93, 95) | 11.94 Lesions | Standard Deviation 10.08 |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Change From Baseline in Total and Each Type of Acne Lesions Count at Month 6 | Comedones Counts: Change at Month 6 (n=93, 95) | 8.21 Lesions | Standard Deviation 7.43 |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Change From Baseline in Total and Each Type of Acne Lesions Count at Month 6 | Papules Counts: Change at Month 6 (n=93, 95) | 2.77 Lesions | Standard Deviation 4.62 |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Change From Baseline in Total and Each Type of Acne Lesions Count at Month 6 | Pustules Counts: Change at Month 6 (n=93, 95) | 0.96 Lesions | Standard Deviation 2.12 |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Change From Baseline in Total and Each Type of Acne Lesions Count at Month 6 | Nodules Counts: Change at Month 6 (n=93, 95) | 0.00 Lesions | Standard Deviation 0 |
Secondary
Change From Baseline in Blood Pressure (BP) at Month 6
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Change From Baseline in Blood Pressure (BP) at Month 6 | Diastolic BP: Change at Month 6 (n=93, 95) | -0.48 Millimeters of Mercury | Standard Deviation 7.76 |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Change From Baseline in Blood Pressure (BP) at Month 6 | Systolic BP: Baseline (n=100/101) | 110.2 Millimeters of Mercury | Standard Deviation 10.61 |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Change From Baseline in Blood Pressure (BP) at Month 6 | Systolic BP: Change at Month 6 (n=93, 95) | -0.24 Millimeters of Mercury | Standard Deviation 8.98 |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Change From Baseline in Blood Pressure (BP) at Month 6 | Diastolic BP: Baseline (n=100/101) | 69.47 Millimeters of Mercury | Standard Deviation 8.54 |
Secondary
Change From Baseline in Body Weight at Month 6
Change from Baseline in body weight is the value at Month 6 minus value at Baseline.
Time frame: Baseline and Month 6
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ethinyl Estradiol/Norgestimate (EE/NGM) | Change From Baseline in Body Weight at Month 6 | Baseline (n=100,101) | 55.62 Kilograms | Standard Deviation 8.92 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | Change From Baseline in Body Weight at Month 6 | Change at Month 6 (n=93,95) | -0.08 Kilograms | Standard Deviation 1.89 |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Change From Baseline in Body Weight at Month 6 | Baseline (n=100,101) | 54.24 Kilograms | Standard Deviation 9.36 |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Change From Baseline in Body Weight at Month 6 | Change at Month 6 (n=93,95) | -0.20 Kilograms | Standard Deviation 2.53 |
Secondary
Number of Participants Non-Compliant With Therapy
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ethinyl Estradiol/Norgestimate (EE/NGM) | Number of Participants Non-Compliant With Therapy | At Month 1 (n=100, 101) | 7 Participants |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | Number of Participants Non-Compliant With Therapy | At Month 3 (n=93, 96) | 13 Participants |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | Number of Participants Non-Compliant With Therapy | At Month 6 (n=93, 95) | 10 Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Number of Participants Non-Compliant With Therapy | At Month 1 (n=100, 101) | 5 Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Number of Participants Non-Compliant With Therapy | At Month 3 (n=93, 96) | 10 Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Number of Participants Non-Compliant With Therapy | At Month 6 (n=93, 95) | 6 Participants |
Secondary
Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ethinyl Estradiol/Norgestimate (EE/NGM) | Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6 | Spotting at Month 1 (n=100,101) | 5 Participants |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6 | Spotting at Month 3 (n=93, 96) | 6 Participants |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6 | Spotting at Month 6 (n=93, 95) | 4 Participants |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6 | Bleeding at Month 1 (n=100,101) | 13 Participants |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6 | Bleeding at Month 3 (n=93, 96) | 4 Participants |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6 | Bleeding at Month 6 (n=93, 95) | 6 Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6 | Bleeding at Month 3 (n=93, 96) | 7 Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6 | Spotting at Month 1 (n=100,101) | 2 Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6 | Bleeding at Month 1 (n=100,101) | 4 Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6 | Spotting at Month 3 (n=93, 96) | 4 Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6 | Bleeding at Month 6 (n=93, 95) | 3 Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6 | Spotting at Month 6 (n=93, 95) | 3 Participants |
Secondary
Number of Participants With Treatment Response at the End-of-Therapy by Participant's Self-Assessment at Month 6
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ethinyl Estradiol/Norgestimate (EE/NGM) | Number of Participants With Treatment Response at the End-of-Therapy by Participant's Self-Assessment at Month 6 | Excellent | 47 Participants |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | Number of Participants With Treatment Response at the End-of-Therapy by Participant's Self-Assessment at Month 6 | Better | 45 Participants |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | Number of Participants With Treatment Response at the End-of-Therapy by Participant's Self-Assessment at Month 6 | No Change | 3 Participants |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | Number of Participants With Treatment Response at the End-of-Therapy by Participant's Self-Assessment at Month 6 | Worse | 4 Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Number of Participants With Treatment Response at the End-of-Therapy by Participant's Self-Assessment at Month 6 | Worse | 1 Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Number of Participants With Treatment Response at the End-of-Therapy by Participant's Self-Assessment at Month 6 | Excellent | 35 Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Number of Participants With Treatment Response at the End-of-Therapy by Participant's Self-Assessment at Month 6 | No Change | 3 Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Number of Participants With Treatment Response at the End-of-Therapy by Participant's Self-Assessment at Month 6 | Better | 58 Participants |
Secondary
Percentage of Participants Showing Treatment Response on the Investigator's Global Assessment at Month 6
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ethinyl Estradiol/Norgestimate (EE/NGM) | Percentage of Participants Showing Treatment Response on the Investigator's Global Assessment at Month 6 | 4 (Excellent) | 43.43 Percentage of participants |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | Percentage of Participants Showing Treatment Response on the Investigator's Global Assessment at Month 6 | 0 (Worse) | 5.05 Percentage of participants |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | Percentage of Participants Showing Treatment Response on the Investigator's Global Assessment at Month 6 | 1 (No Change) | 4.04 Percentage of participants |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | Percentage of Participants Showing Treatment Response on the Investigator's Global Assessment at Month 6 | 2 (Fair) | 4.04 Percentage of participants |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | Percentage of Participants Showing Treatment Response on the Investigator's Global Assessment at Month 6 | 3 (Good) | 43.43 Percentage of participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Percentage of Participants Showing Treatment Response on the Investigator's Global Assessment at Month 6 | 3 (Good) | 52.58 Percentage of participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Percentage of Participants Showing Treatment Response on the Investigator's Global Assessment at Month 6 | 2 (Fair) | 23.71 Percentage of participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Percentage of Participants Showing Treatment Response on the Investigator's Global Assessment at Month 6 | 0 (Worse) | 1.03 Percentage of participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Percentage of Participants Showing Treatment Response on the Investigator's Global Assessment at Month 6 | 4 (Excellent) | 21.65 Percentage of participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Percentage of Participants Showing Treatment Response on the Investigator's Global Assessment at Month 6 | 1 (No Change) | 1.03 Percentage of participants |
Secondary
Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 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 |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6 | Level 3: Month 6 (n=93, 95) | 29.47 Percentage of Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6 | Level 1: Baseline (n=100,101) | 3.96 Percentage of Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6 | Level 1: Month 3 (n=93, 96) | 10.42 Percentage of Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6 | Level 2: Baseline (n=100,101) | 12.87 Percentage of Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6 | Level 1: Month 6 (n=93, 95) | 22.11 Percentage of Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6 | Level 3: Baseline (n=100,101) | 44.55 Percentage of Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6 | Level 2: Month 3 (n=93, 96) | 14.58 Percentage of Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6 | Level 4: Baseline (n=100,101) | 34.65 Percentage of Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6 | Level 5: Month 6 (n=93, 95) | 0.00 Percentage of Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6 | Level 5: Baseline (n=100,101) | 3.96 Percentage of Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6 | Level 3: Month 3 (n=93, 96) | 59.38 Percentage of Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6 | Level 1: Month 1 (n=100,101) | 8.91 Percentage of Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6 | Level 2: Month 6 (n=93, 95) | 43.16 Percentage of Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6 | Level 2: Month 1 (n=100,101) | 11.88 Percentage of Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6 | Level 4: Month 3 (n=93, 96) | 14.58 Percentage of Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6 | Level 3: Month 1 (n=100,101) | 45.54 Percentage of Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6 | Level 4: Month 6 (n=93, 95) | 5.26 Percentage of Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6 | Level 4: Month 1 (n=100,101) | 32.67 Percentage of Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6 | Level 5: Month 3 (n=93, 96) | 1.04 Percentage of Participants |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6 | Level 5: Month 1 (n=100,101) | 0.99 Percentage of Participants |