Sponsor study identifier
Secondary identifiers
interventional
201
1 country
3
Study Start
December 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2010
Actual (reported)Study Completion
March 2010
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2008
Date type not reportedThis date has not been verified as actual or estimated.
March 2010
Actual (reported)March 2010
Actual (reported)October 24, 2011
Actual (reported)November 8, 2011
Actual (reported)June 19, 2013
Actual (reported)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
Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6
Month 1, 3 and 6
Number of Participants Non-Compliant With Therapy
Month 1, 3 and 6
Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6
Baseline and Month 1, 3 and 6
Percentage of Participants Showing Treatment Response on the Investigator's Global Assessment at Month 6
Month 6
Number of Participants With Treatment Response at the End-of-Therapy by Participant's Self-Assessment at Month 6
Month 6
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.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Ethinyl estradiol/Desogestrel (EE/DSG)
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordContact the study team to confirm eligibility.
Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand
Department of Obstetrics and Gynecology, Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, Thailand
Department of Obstetrics and Gynecology, Faculty of Medicine, Chiang Mai University
Chiang Mai, Thailand
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.
Janssen-Cilag Ltd., Thailand Clinical Trial
Janssen-Cilag Ltd.,Thailand
201 participants (actual enrollment reported by the registry).
First Submitted
October 24, 2011
First Posted
November 8, 2011
Study Start
December 2008
Date type not reportedThis date has not been verified as actual or estimated.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Primary Completion
March 2010
Actual (reported)Study Completion
March 2010
Actual (reported)Last Updated
June 19, 2013
Results First Posted
June 19, 2013
Record last verified: 2013-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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