An Efficacy and Safety Study Comparing Oral Contraceptive... | NCT01466673

NCT01466673

ID	Type	Description	Link
NRGMONCON4003

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ethinyl estradiol/Norgestimate (EE/NGM)	Experimental		Drug: Ethinyl estradiol/Norgestimate (EE/NGM)
Ethinyl estradiol/Desogestrel (EE/DSG)	Active Comparator		Drug: Ethinyl estradiol/Desogestrel (EE/DSG)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ethinyl estradiol/Norgestimate (EE/NGM)	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Baseline and Month 1
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.	Baseline and Month 3
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.	Baseline and Month 6

Secondary Outcomes

Measure	Description	Time Frame
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.	Month 1, 3 and 6
Number of Participants Non-Compliant With Therapy

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Janssen-Cilag Ltd., Thailand Clinical Trial	Janssen-Cilag Ltd.,Thailand	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25074072	Derived	Jaisamrarn U, Chaovisitsaree S, Angsuwathana S, Nerapusee O. A comparison of multiphasic oral contraceptives containing norgestimate or desogestrel in acne treatment: a randomized trial. Contraception. 2014 Nov;90(5):535-41. doi: 10.1016/j.contraception.2014.06.002. Epub 2014 Jun 12.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000100 BG001101 BG002201

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Number

Participants

Title

Denominators

Categories

Comedones Counts: Baseline

Title	Measurements
	OG00010.97± 6.45 OG00111.43± 7.58

Papules Counts: Baseline

Title	Measurements
	OG000

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.

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.

Posted

Mean

Standard Deviation

Lesions

Baseline and Month 3

ID	Title	Description
OG000	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.
OG001	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.

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.

Posted

Mean

Standard Deviation

Lesions

Baseline and Month 6

ID	Title	Description
OG000	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.
OG001	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.

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.

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.

Posted

Number

Participants

Month 1, 3 and 6

ID	Title	Description
OG000	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.
OG001	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.

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.

Posted

Number

Participants

Month 1, 3 and 6

ID	Title	Description
OG000	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.
OG001	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.

Units

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.

Posted

Number

Percentage of Participants

Baseline and Month 1, 3 and 6

ID	Title	Description
OG000	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.
OG001	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.

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.

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.

Posted

Number

Percentage of participants

Month 6

ID	Title	Description
OG000	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.
OG001	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.

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.

Posted

Number

Participants

Month 6

ID	Title	Description
OG000	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.
OG001	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.

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.

Posted

Mean

Standard Deviation

Millimeters of Mercury

Baseline and Month 6

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts

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.

Posted

Mean

Standard Deviation

Kilograms

Baseline and Month 6

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.			2	100	34	100
EG001	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.			0	101	60	101

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Migraine	Nervous system disorders	MedDRA Version 14.0	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected101 at risk
Sudden severe headache	Nervous system disorders	MedDRA Version 14.0	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected101 at risk
Dengue Hemorrhagic fever	Infections and infestations	MedDRA Version 14.0	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected101 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA Version 14.0	Non-systematic Assessment	EG00013 affected100 at risk EG00127 affected101 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 14.0	Non-systematic Assessment	EG0001 affected100 at risk EG0012 affected101 at risk
Flatulence	Gastrointestinal disorders	MedDRA Version 14.0	Non-systematic Assessment	EG0000 affected100 at risk EG0011 affected101 at risk
Oedema peripheral	General disorders	MedDRA Version 14.0	Non-systematic Assessment	EG0004 affected100 at risk EG0010 affected101 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA Version 14.0	Non-systematic Assessment	EG0000 affected100 at risk EG0011 affected101 at risk
Headache	Nervous system disorders	MedDRA Version 14.0	Non-systematic Assessment	EG0005 affected100 at risk EG00110 affected101 at risk
Somnolence	Nervous system disorders	MedDRA Version 14.0	Non-systematic Assessment	EG0003 affected100 at risk EG0012 affected101 at risk
Dizziness	Nervous system disorders	MedDRA Version 14.0	Non-systematic Assessment	EG0000 affected100 at risk EG0013 affected101 at risk
Depression	Psychiatric disorders	MedDRA Version 14.0	Non-systematic Assessment	EG0000 affected100 at risk EG0011 affected101 at risk
Breast pain	Reproductive system and breast disorders	MedDRA Version 14.0	Non-systematic Assessment	EG0005 affected100 at risk EG0019 affected101 at risk
Libido increased	Reproductive system and breast disorders	MedDRA Version 14.0	Non-systematic Assessment	EG0000 affected100 at risk EG0012 affected101 at risk
Galactorrhoea	Reproductive system and breast disorders	MedDRA Version 14.0	Non-systematic Assessment	EG0001 affected100 at risk EG0010 affected101 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA Version 14.0	Non-systematic Assessment	EG0002 affected100 at risk EG0012 affected101 at risk

ID	Term
D000152	Acne Vulgaris

ID	Term
D004997	Ethinyl Estradiol
C017576	norgestimate
D017135	Desogestrel

Ancestor Terms

ID	Term
D009651	Norpregnatrienes
D009650	Norpregnanes
D009654	Norsteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D042782	Estrogenic Steroids, Alkylated
D045166	Estradiol Congeners
D012739	Gonadal Steroid Hormones
D042341	Gonadal Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D009652	Norpregnenes

Units	Counts
Participants	OG000100 OG001101

ID	Term
D017486	Acneiform Eruptions
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012625	Sebaceous Gland Diseases