Comparison of Body Weight Change During Contraception With Belara and Yasmin
Information source: Mahidol University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Body Weight Changes
Intervention: 30 mcg ethinylestradiol/2 mg chlormadinone acetate (Drug); 30 mcg ethinylestradiol/3 mg drospirenone (Drug)
Phase: Phase 4
Status: Enrolling by invitation
Sponsored by: Mahidol University
Summary
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: body weight change
Secondary outcome: efficacy in contraception (pregnancy rate)Other side effects satisfaction
Detailed description:
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.
Eligibility
Minimum age: 19 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Reproductive woman
- Woman who has BMI < 28. 5 kg/m2.
- Woman who has regular menstruation.
- Woman who don't have pelvic organ disorder.
- Woman who want contraception with oral contraceptive pills.
Exclusion Criteria:
- Woman who has abnormal blood pressure
- Woman who has abnormal vaginal bleeding
- Pregnant woman
- Woman who on medication effect contraceptive pills, such as anti-fungal,
anti-retroviral, anti-convulsant drug.
- Woman who has contraindication for OCP.
- Woman who use steroid in 3 month period before enrollment in this study.
- Smoking
- Woman who has eating habit disorder.
Locations and Contacts
Family Planning Unit, Department of Obstetric and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand
Additional Information
SIRB Human Research Protection Unit
Starting date: June 2012
Last updated: April 7, 2015
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