Comparison of Body Weight Change During Contraception With Belara and Yasmin

Mahidol University

Status and phase

Unknown

Phase 4

Conditions

Body Weight Changes

Treatments

Drug: 30 mcg ethinylestradiol/3 mg drospirenone

Drug: 30 mcg ethinylestradiol/2 mg chlormadinone acetate

Study type

Interventional

Funder types

Other

Identifiers

NCT01608698

015532040 (Other Grant/Funding Number)

R015532040

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

19 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.