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An Efficacy and Safety Study Comparing Oral Contraceptive Containing Norgestimate or Desogestrel for Acne Treatment

NCT01466673 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2013-06-19

Study results available
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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).

Conditions

  • Acne Vulgaris

Interventions

DRUG

Ethinyl 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.

DRUG

Ethinyl 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 & Collaborators

  • Janssen-Cilag Ltd.,Thailand

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag Ltd., Thailand Clinical Trial · Janssen-Cilag Ltd.,Thailand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01466673 on ClinicalTrials.gov