Comparison of Body Weight Change During Contraception With Belara and Yasmin
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Body Weight Changes |
Drug: 30 mcg ethinylestradiol/2 mg chlormadinone acetate Drug: 30 mcg ethinylestradiol/3 mg drospirenone |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
- body weight change [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]Compare the body weight change during use of two OCP (30 mcg ethinylestradiol/2 mg chlormadinone acetate (Belara®) and 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin®)). By follow up at 3rd and final at 6th month of use.
- efficacy in contraception (pregnancy rate) [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]To evaluate contraceptive efficacy of two OCP. Urine pregnancy test was used to evaluate pregnancy, the participant was tested in every visit of the study.
- Other side effects [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]To evaluate other side effects during using both OCP,such as vaginal spotting, androgenic effect, blood pressure, headache and GI effect. Vaginal spotting was classified by number of pad (WHO definition) which the participant used in each cycle and record in menstrual card. Androgenic effect was classified by Modified Ferriman - Gallway Score for hirsutism (score > 7), American Academy of Dermatology Concensus 2009 on acne classification (mild, moderate, severe)for acne, systolic/diastolic blood pressure and the presence or no presence of headach and GI discomfort.
- satisfaction [ Time Frame: 6 month ] [ Designated as safety issue: No ]To compare satisfaction in study process. In each visit (first, 3rd month and 6th month of study period). The participant was evaluated satisfaction in topics of diagnosis, timing of study process, information from the staff about the study process and the way to use oral pills, quality of the oral pills and conclusive satisfaction. The rating of satisfaction was categorised in five levels as five scoring numbers by using questionnaire; 5=extreme satisfaction, 4=very satisfaction, 3=moderate satisfaction, 2= little satisfaction, 1=no satisfaction.
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Belara
The participants who receive OCP in combination of 30 mcg ethinylestradiol/2 mg chlormadinone acetate (Belara®).
|
Drug: 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.
Other Name: Belara
|
|
Experimental: Yasmin
The participants who receive OCP in combination of 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin®).
|
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.
Other Name: Yasmin
|
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| Ages Eligible for Study: | 19 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Mahidol University |
| ClinicalTrials.gov Identifier: | NCT01608698 History of Changes |
| Other Study ID Numbers: | R015532040, 015532040 |
| Study First Received: | May 21, 2012 |
| Last Updated: | May 30, 2012 |
| Health Authority: | Thailand: Ethical Committee |
Keywords provided by Mahidol University:
|
chlormadinone acetate drospirenone contraceptive pills |
Additional relevant MeSH terms:
|
Body Weight Body Weight Changes Signs and Symptoms Chlormadinone Acetate Drospirenone Ethinyl Estradiol Drospirenone and ethinyl estradiol combination Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents |
Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Androgen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Estrogens Hormones Aldosterone Antagonists |
ClinicalTrials.gov processed this record on June 17, 2013