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Body Weight ChangesPhase 4NCT01608698

Comparison of Body Weight Change During Contraception With Belara and Yasmin

A Phase 4 study testing 30 mcg ethinylestradiol/2 mg chlormadinone acetate and 30 mcg ethinylestradiol/3 mg drospirenone in people with Body Weight Changes, run by Mahidol University at 1 site in Thailand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Body Weight Changes
What is being tested?
30 mcg ethinylestradiol/2 mg chlormadinone acetate and 30 mcg ethinylestradiol/3 mg drospirenone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteThailand
Study dates
Jun 2012to Feb 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Thailand1 site

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

    Bangkok, Bangkok, 10700

Other trials in Thailand

About this study

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

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.

Read the 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.

Being tested
30 mcg ethinylestradiol/2 mg chlormadinone acetate, 30 mcg ethinylestradiol/3 mg drospirenone
Keywords
chlormadinone acetate, drospirenone, contraceptive pills
Medical subject headings
Body Weight Changes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 30 mcg ethinylestradiol/2 mg chlormadinone acetateDrug

    Also called Belara

    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.

  • 30 mcg ethinylestradiol/3 mg drospirenoneDrug

    Also called Yasmin

    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.

Study groups in NCT01608698
Study groupRoleWhat they receive
BelaraExperimentalThe participants who receive OCP in combination of 30 mcg ethinylestradiol/2 mg chlormadinone acetate (Belara®).
Receives: Drug: 30 mcg ethinylestradiol/2 mg chlormadinone acetate
YasminExperimentalThe participants who receive OCP in combination of 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin®).
Receives: Drug: 30 mcg ethinylestradiol/3 mg drospirenone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. body weight change

    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.

    Measured: 6 month

Secondary outcomes (3)

  1. efficacy in contraception (pregnancy rate)

    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.

    Measured: 6 month

  2. Other side effects

    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.

    Measured: 6 month

  3. satisfaction

    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.

    Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionJan 2016 (estimated)
  4. Study completionFeb 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01608698
Sponsor's protocol ID
R015532040
Other IDs
015532040
Status last verified
Apr 2015
First submitted
21 May 2012
Last updated
9 Apr 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 31756117

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 30 mcg ethinylestradiol/2 mg chlormadinone acetate and 30 mcg ethinylestradiol/3 mg drospirenone in people with Body Weight Changes, run by Mahidol University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

body weight change (time frame: 6 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01608698, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2015.

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