Beneficial effect from oral contraceptive to subjects. combined oral contraceptive pills,
Conditions
Interventions
Belara® is a monophasic combined oral contraceptive containing EE 30 mcg and CMA 2 mg per tablet. One pack consist of 21 hormone tablets.,Yasmin® is a monophasic combined oral contraceptive ontainin
Active Comparator Drug,Active Comparator Drug
Belara®,Yasmin®
Sponsors
Assoc.Prof. Unnop Jaisamrarn
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Need contraception 2. Have mild to moderate acne vulgaris 3. Having dysmerorrhea of any degree of severity 4. Agree to take only the supplied study drug as treatment for acne and dysmeorrhea during the six-month treatment phase of the study 5. Sign and Date an informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Can understands or follow the instructions given in the study 2. Pregnant or nursing 3. Know hypersensitivity to any of the study medication 4. Any coexisting medical condition or were taking any concomitant medication that is likely to interfere with safe administration of Belara and/or Yasmin, in the investigator's opinion. 5. Taking systematic retinoids, systemic antimicrobials, and topical acne treatments within 6months, 1 month and 2 weeks prior to enrollment, respectively 6. Any of the following contraindications to oral contraceptives: -Current thormbophlebitis or thromboembolic disorders -Past history of deep vein thromobophlebitis or thromboembolic disorders -Cerebral vascular or coronary artery disease or known severe hypertension -Diabetes with vascular involvement -Known or suspected carcinoma of the breast -Known or suspected estrogen-dependent neoplasia -Undiagnosed, abnormal genital bleeding -Neurovascular lesion of the eye or serious visual disturbances -Cardiac arrhythmia -Cholestasis -Hypophyseal adenoma -Uncontrolled hypertension -Smoking 7. Taking other investigational medication or oral contraceptive products within 30 days prior to entering the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the efficacy of treatment between Belara on acne with Yasmin in Thai women 1,3 and 6 months (6-consecutive menstrual cycles) Physical examination and Statistic analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the efficacy of Betara compared to Yasmin on dysmenorrhea 1,3 and 6 months (6-consecutive menstrual cycles) Physical examination and Statistic analysis,Clinical effect and safety profiles including cycle control, blood pressure and body weight 1,3 and 6 months (6-consecutive menstrual cycles) Self assessment questionnaire, physical examination and statistic analysis | — |
Countries
Thailand
Contacts
Public ContactPichet Kamolrungsantisuk
Medical Research Network of the Consortium of Thai Medical Schools :MedResNet (Thailand)
Outcome results
None listed