CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 201 enrolled
Drug / intervention
Ethinyl estradiol/Norgestimate (EE/NGM) +1 moredrug
Likely dose
Ethinyl estradiol/Norgestimate (EE/NGM) 0.18 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01466673
NCT01466673Phase 4Completed
CompareCT.gov

Comparative Study of the Effect on Acne With Norgestimate Containing Triphasic Oral Contraceptive and Biphasic Preparation Containing Desogestrel

Janssen-Cilag Ltd.,Thailand·interventional·Posted Nov 8, 2011·Updated Jun 19, 2013

In Brief

A Phase 4 clinical trial evaluating Ethinyl estradiol/Norgestimate (EE/NGM) and Ethinyl estradiol/Desogestrel (EE/DSG) for Acne Vulgaris. Completed, enrolled 201 participants across 3 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne Vulgaris
CountriesThailand
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 8, 2011
Enrollment StartDec 1, 2008
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.7 years ago

Interventions

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.

Ethinyl estradiol/Desogestrel (EE/DSG)drug

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.