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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

Page last updated: August 23, 2015

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