Trials / Completed
CompletedNCT00752635
Comparison of Efficacy and Safety of Norgestimate-ethinyl Estradiol and Cyproterone Acetate-ethinyl Estradiol in the Treatment of Acne Vulgaris
Comparison of Efficacy and Safety of Tricilest (Norgestimate-ethinyl Estradiol) and Diane-35 (Cyproterone Acetate-ethinyl Estradiol) in the Treatment of Acne Vulgaris
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Johnson & Johnson Taiwan Ltd · Industry
- Sex
- Female
- Age
- 15 Years – 49 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study was to evaluate the effectiveness and safety of norgestimate-ethinyl estradiol as comparted with cyproterone acetate-ethinyl estradiol among female patients with moderate acne vulgaris.
Detailed description
This study was to evaluate the efficacy and safety of TriCilest as comparted with Diane-35 among female patients with moderate acne vulgaris. The study design was double-blind, randomized, parallel and active controlled. The sponsor planned to recruit approximately 50 patients to complete 40 evaluable patients. At the end of the study, a total of 48 patients were randomized. TriCilest (noregestimate-ethinyl estradiol), 0.18mg-0.035mg or 0.215mg-0.035mg or 0.25mg-0.035mg, Oral admistration, The duration was three consecutive menstrual cycles.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Norgestimate-ethinyl estradiol; Cyproterone acetate-ethinyl estradiol |
Timeline
- Start date
- 2004-09-01
- Completion
- 2005-09-01
- First posted
- 2008-09-15
- Last updated
- 2011-05-19
Source: ClinicalTrials.gov record NCT00752635. Inclusion in this directory is not an endorsement.