Comparison of Body Weight Change During Contraception With Belara and Yasmin

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT01608698
First received: May 21, 2012
Last updated: March 21, 2014
Last verified: March 2014
  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

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 Consensus 2009 on acne classification (mild, moderate, severe)for acne, systolic/diastolic blood pressure and the presence or no presence of headache 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 2014
Estimated Primary Completion Date: June 2014 (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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608698

Locations
Thailand
Family Planning Unit, Department of Obstetric and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
  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: March 21, 2014
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 July 26, 2014