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Sponsored by: |
Johnson & Johnson Taiwan Ltd |
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Information provided by: | Johnson & Johnson Taiwan Ltd |
ClinicalTrials.gov Identifier: | NCT00752635 |
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.
Condition | Intervention | Phase |
---|---|---|
Acne Vulgaris |
Drug: Norgestimate-ethinyl estradiol; Cyproterone acetate-ethinyl estradiol |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparison of Efficacy and Safety of Tricilest (Norgestimate-Ethinyl Estradiol) and Diane-35 (Cyproterone Acetate-Ethinyl Estradiol) in the Treatment of Acne Vulgaris |
Enrollment: | 48 |
Study Start Date: | September 2004 |
Study Completion Date: | September 2005 |
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.
Ages Eligible for Study: | 15 Years to 49 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR007129 |
Study First Received: | September 11, 2008 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00752635 |
Health Authority: | Taiwan: Department of Health |
TriCilest acne vulgaris |
Facial Dermatoses Skin Diseases Facies Benzoates Estradiol valerate Cyproterone Acetate Cyproterone Ethinyl Estradiol Sebaceous Gland Diseases |
Estradiol 17 beta-cypionate Acne Vulgaris Estradiol Exanthema Norgestimate Moxifloxacin Estradiol 3-benzoate Diane Polyestradiol phosphate |
Anti-Infective Agents Estrogens Antineoplastic Agents Contraceptive Agents Hormone Antagonists Contraceptives, Oral Physiological Effects of Drugs Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists |
Reproductive Control Agents Contraceptive Agents, Male Hormones Pharmacologic Actions Androgen Antagonists Acneiform Eruptions Therapeutic Uses Contraceptives, Oral, Synthetic |