Status:
COMPLETED
An Efficacy and Safety Study Comparing Oral Contraceptive Containing Norgestimate or Desogestrel for Acne Treatment
Lead Sponsor:
Janssen-Cilag Ltd.,Thailand
Conditions:
Acne Vulgaris
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
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 particip...
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 fema...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT01466673
Start Date
December 1 2008
End Date
March 1 2010
Last Update
June 19 2013
Active Locations (3)
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1
Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand
2
Department of Obstetrics and Gynecology, Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, Thailand
3
Department of Obstetrics and Gynecology, Faculty of Medicine, Chiang Mai University
Chiang Mai, Thailand