An Efficacy and Safety Study Comparing Oral Contraceptive Containing Norgestimate or Desogestrel for Acne Treatment
Comparative Study of the Effect on Acne With Norgestimate Containing Triphasic Oral Contraceptive and Biphasic Preparation Containing Desogestrel
2 other identifiers
interventional
201
1 country
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2008
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 24, 2011
CompletedFirst Posted
Study publicly available on registry
November 8, 2011
CompletedResults Posted
Study results publicly available
June 19, 2013
CompletedJune 19, 2013
June 1, 2013
1.2 years
October 24, 2011
February 22, 2013
June 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 (7)
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
- +2 more secondary outcomes
Study Arms (2)
Ethinyl estradiol/Norgestimate (EE/NGM)
EXPERIMENTALEthinyl estradiol/Desogestrel (EE/DSG)
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
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
Related Publications (1)
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.
PMID: 25074072DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Affairs Director
- Organization
- Medical Affairs, Janssen-Cilag (Thailand)
Study Officials
- STUDY DIRECTOR
Janssen-Cilag Ltd., Thailand Clinical Trial
Janssen-Cilag Ltd.,Thailand
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2011
First Posted
November 8, 2011
Study Start
December 1, 2008
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
June 19, 2013
Results First Posted
June 19, 2013
Record last verified: 2013-06