A Phase 4 interventional study of 30 mcg ethinylestradiol/2 mg chlormadinone acetate and 30 mcg ethinylestradiol/3 mg drospirenone in Body Weight Changes, sponsored by Mahidol University. Status unknown at 1 site in Thailand. Open to female participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-09.
Sponsored by Mahidol University · Phase 4, Interventional, and Treatment
The purpose of this study is to evaluate different side effect in contraceptive use of two oral combined contraceptive pills (OCP)in combination of 30 mcg ethinylestradiol/2 mg chlormadinone acetate (Belara®) and 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin®), especially body weight change.
Oral combined contraceptive pills (OCP) is the most contraceptive use in reproductive women. The various type of progestins in OCP give various effects either benefit (non-contraceptive benefit) and side effect. These effects depend on pharmacological activity of each progestin. Many studies showed causes of discontinuation use of OCP, such as increase body weight,androgenic effect and vaginal spotting. OCP in combination of 30 mcg ethinylestradiol/2 mg chlormadinone acetate (Belara®) and 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin®)are the common used in practice. The each type of progestin (chlormadinone and drospirenone) might effect different outcomes in women especially in body weight change during use. Chlormadinone is a C-21 progestin which has glucocorticoid and antiandrogenic effect. Drospirenone is a progestin in spironolactone derivative which has antimineralocorticoid and antiandrogenic effect. Both progestins might has less effect in body weight change and provide other non-contraceptive benefits. So investigator want to study the different effects from these progestin in two type of OCP. The result from this study could give information to choose the proper OCP for each reproductive woman.
217 studies on the registry are indexed under Body Weight Changes; 31 are open to participants now.
This study's planned enrollment of 100 is above the median of 70 across 165 interventional studies indexed under Body Weight Changes.
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Exclusion Criteria:
The participants who receive OCP in combination of 30 mcg ethinylestradiol/2 mg chlormadinone acetate (Belara®).
Drug: 30 mcg ethinylestradiol/2 mg chlormadinone acetate
The participants who receive OCP in combination of 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin®).
Drug: 30 mcg ethinylestradiol/3 mg drospirenone
Drug page: Ethinyl Estradiol
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.
Also known as: Belara
Drug pages: Ethinyl Estradiol · 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.
Also known as: Yasmin
body weight change
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.
Time frame: 6 month
efficacy in contraception (pregnancy rate)
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.
Time frame: 6 month
Other side effects
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.
Time frame: 6 month
satisfaction
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.
Time frame: 6 month
The record gives a start of Jun 2012, a primary completion of Jan 2016 and a completion of Feb 2016. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ethinyl Estradiol · Drospirenone