Comparison of Body Weight Change During Contraception With Belara and Yasmin

NCT ID: NCT01608698

Last Updated: 2015-04-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2016-02-29

Brief 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.

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.

Conditions

Body Weight Changes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Belara

The participants who receive OCP in combination of 30 mcg ethinylestradiol/2 mg chlormadinone acetate (Belara®).

Group Type: EXPERIMENTAL

30 mcg ethinylestradiol/2 mg chlormadinone acetate

Intervention Type: DRUG

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.

Yasmin

The participants who receive OCP in combination of 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin®).

Group Type: EXPERIMENTAL

30 mcg ethinylestradiol/3 mg drospirenone

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Belara; Yasmin

Eligibility 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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Family Planning Unit, Department of Obstetric and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Bangkok, Thailand

Countries

Thailand

References

Wongwananuruk T, Panichyawat N, Panchalee T, Jirakittidul P, Angsuwathana S, Sirimai K, Thamkhantho M, Chiravacharadej G. Comparison of change in body weight between contraception containing 30-mug ethinylestradiol/2-mg chlormadinone acetate or 30-mug ethinylestradiol/3-mg drospirenone: a randomised controlled trial. Eur J Contracept Reprod Health Care. 2020 Feb;25(1):43-48. doi: 10.1080/13625187.2019.1688290. Epub 2019 Nov 22.

Reference Type: DERIVED

PMID: 31756117 (View on PubMed)

Other Identifiers

015532040

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

R015532040

Identifier Type: -

Identifier Source: org_study_id