NCT01608698

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 31, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

April 9, 2015

Status Verified

April 1, 2015

Enrollment Period

3.6 years

First QC Date

May 21, 2012

Last Update Submit

April 7, 2015

Conditions

Body Weight Changes

Keywords

chlormadinone acetatedrospirenonecontraceptive pills

Outcome Measures

Primary Outcomes (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.

    6 month

Secondary Outcomes (3)

  • efficacy in contraception (pregnancy rate)

    6 month

  • Other side effects

    6 month

  • satisfaction

    6 month

Study Arms (2)

Belara

EXPERIMENTAL

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

Drug: 30 mcg ethinylestradiol/2 mg chlormadinone acetate

Yasmin

EXPERIMENTAL

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

Drug: 30 mcg ethinylestradiol/3 mg drospirenone

Interventions

30 mcg ethinylestradiol/2 mg chlormadinone acetateDRUG

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.

Also known as: Belara
Belara
30 mcg ethinylestradiol/3 mg drospirenoneDRUG

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.

Also known as: Yasmin
Yasmin

Eligibility Criteria

Age19 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bangkok, Bangkok, 10700, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 31756117DERIVED

MeSH Terms

Conditions

Body Weight Changes

Interventions

Belaradrospirenone and ethinyl estradiol combination

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2012

First Posted

May 31, 2012

Study Start

June 1, 2012

Primary Completion

January 1, 2016

Study Completion

February 1, 2016

Last Updated

April 9, 2015

Record last verified: 2015-04

Locations

TH(1)