Clinical trial NCT01608698: Comparison of Body Weight Change During Contraception With Belara and Yasmin
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Body Weight Changes
Keywords: chlormadinone acetate
drospirenone
contraceptive pills
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2012-05-31
Enrollment: 100
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: body weight change
timeFrame: 6 month
Secondary outcomes:
measure: efficacy in contraception (pregnancy rate)
timeFrame: 6 month
measure: Other side effects
timeFrame: 6 month
measure: satisfaction
timeFrame: 6 month
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Family Planning Unit, Department of Obstetric and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
References:
citation: 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.