A randomized, investigator-blinded comparative study of non-contraceptive benefits of combined oral contraceptives containing chlormadinone acetate versus drospirenone

Phase 4

Active, not recruiting

• Conditions: Beneficial effect from oral contraceptive to subjects.; combined oral contraceptive pills, skin disorder, dysmenorrhoea&#44

• Registration Number: TCTR20170518001
• Lead Sponsor: Assoc.Prof. Unnop Jaisamrarn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-09-25
• Study Start: 2017-05-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 180

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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