Comparison of Body Weight Change During Contraception With Belara and Yasmin
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01608698|
Recruitment Status : Unknown
Verified April 2015 by Mahidol University.
Recruitment status was: Enrolling by invitation
First Posted : May 31, 2012
Last Update Posted : April 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Body Weight Changes||Drug: 30 mcg ethinylestradiol/2 mg chlormadinone acetate Drug: 30 mcg ethinylestradiol/3 mg drospirenone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Comparison of Body Weight Changing and Side Effects Between Treatment With 30 mcg Ethinylestradiol/2 mg Chlormadinone Acetate (Belara®) and 30 mcg Ethinylestradiol/3 mg Drospirenone (Yasmin®): A Randomized Control Trial|
|Study Start Date :||June 2012|
|Estimated Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||February 2016|
The participants who receive OCP in combination of 30 mcg ethinylestradiol/2 mg chlormadinone acetate (Belara®).
Drug: 30 mcg ethinylestradiol/2 mg chlormadinone acetate
By orally 1 tablet before bedtime for 21 days and withdrawal 7 days after that start the new cycle. Total study period is 6 cycles of pills.
Other Name: Belara
The participants who receive OCP in combination of 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin®).
Drug: 30 mcg ethinylestradiol/3 mg drospirenone
By orally 1 tablet before bedtime for 21 days then withdrawal 7 days after that start the new cycle. Total study period is 6 cycles of pills.
Other Name: Yasmin
- body weight change [ Time Frame: 6 month ]Compare the body weight change during use of two OCP (30 mcg ethinylestradiol/2 mg chlormadinone acetate (Belara®) and 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin®)). By follow up at 3rd and final at 6th month of use.
- efficacy in contraception (pregnancy rate) [ Time Frame: 6 month ]To evaluate contraceptive efficacy of two OCP. Urine pregnancy test was used to evaluate pregnancy, the participant was tested in every visit of the study.
- Other side effects [ Time Frame: 6 month ]To evaluate other side effects during using both OCP,such as vaginal spotting, androgenic effect, blood pressure, headache and GI effect. Vaginal spotting was classified by number of pad (WHO definition) which the participant used in each cycle and record in menstrual card. Androgenic effect was classified by Modified Ferriman - Gallway Score for hirsutism (score > 7), American Academy of Dermatology Consensus 2009 on acne classification (mild, moderate, severe)for acne, systolic/diastolic blood pressure and the presence or no presence of headache and GI discomfort.
- satisfaction [ Time Frame: 6 month ]To compare satisfaction in study process. In each visit (first, 3rd month and 6th month of study period). The participant was evaluated satisfaction in topics of diagnosis, timing of study process, information from the staff about the study process and the way to use oral pills, quality of the oral pills and conclusive satisfaction. The rating of satisfaction was categorised in five levels as five scoring numbers by using questionnaire; 5=extreme satisfaction, 4=very satisfaction, 3=moderate satisfaction, 2= little satisfaction, 1=no satisfaction.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01608698
|Family Planning Unit, Department of Obstetric and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University|
|Bangkok, Thailand, 10700|