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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 History of Changes |
Health Authority: | Taiwan: Department of Health |
TriCilest acne vulgaris |
Anti-Infective Agents Facial Dermatoses Contraceptive Agents Hormone Antagonists Contraceptives, Oral Estradiol valerate Contraceptive Agents, Female Cyproterone Hormones, Hormone Substitutes, and Hormone Antagonists Estradiol 17 beta-cypionate Sebaceous Gland Diseases Contraceptive Agents, Male Hormones Acne Vulgaris Exanthema |
Moxifloxacin Estradiol 3-benzoate Polyestradiol phosphate Diane Estrogens Facies Skin Diseases Benzoates Cyproterone Acetate Ethinyl Estradiol Estradiol Norgestimate Androgen Antagonists Androgens |
Anti-Infective Agents Facial Dermatoses Antineoplastic Agents Contraceptive Agents Hormone Antagonists Contraceptives, Oral Estradiol valerate Physiological Effects of Drugs Contraceptive Agents, Female Cyproterone Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Estradiol 17 beta-cypionate Sebaceous Gland Diseases Contraceptive Agents, Male |
Hormones Acne Vulgaris Acneiform Eruptions Moxifloxacin Estradiol 3-benzoate Therapeutic Uses Contraceptives, Oral, Synthetic Diane Polyestradiol phosphate Estrogens Skin Diseases Cyproterone Acetate Ethinyl Estradiol Estradiol Pharmacologic Actions |