Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000889651
Ethics application status
Approved
Date submitted
5/08/2014
Date registered
21/08/2014
Date last updated
10/12/2020
Date data sharing statement initially provided
10/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of desogestrel and levonorgestrel releasing intrauterine device in terms of menstrual pattern, side effects and patient satisfaction in postpartum contraception
Scientific title
Comparison of desogestrel and levonorgestrel releasing intrauterine device in terms of menstrual pattern, side effects and patient satisfaction in postpartum contraception
Secondary ID [1] 285107 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postpartum contraception 292659 0
Condition category
Condition code
Reproductive Health and Childbirth 292974 292974 0 0
Contraception

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Arm 1: Desogestrel 75 mcg/day orally 28 days, continously, observation for 12 months.
Arm 2: Levonorgestrel releasing intrauterine device applied by the physician which releases 20mcg levonorgestrel/day into the endometrial cavity, observation for 12 months.
Intervention code [1] 289957 0
Not applicable
Comparator / control treatment
Two contraceptive methods will be compared. (Desogestrel orally versus levonorgestrel releasing intrauterine device)
Control group
Active

Outcomes
Primary outcome [1] 292831 0
Primary outcome is the menstrual pattern of the patient
Patients willing to participate into the study will be given a calender and they will be asked to mark the days with spotting, days with bleeding or days with heavy bleeding each month.
Timepoint [1] 292831 0
Third month, sixth month and 1st year after the method was started
Secondary outcome [1] 309770 0
Side effects of desogestrel or levonorgestrel releasing intrauterine device.
Possible side effects will be asked to the patiens and side effect notification forms will be filled up by the physician.
Irregular bleeding
Spotting
Headache
Nausea
Breast tenderness
Depressive symptoms
Acne
Amenorrhea
Weight gain
Mood changes
Vaginal discharge
Pelvic infection
Others
Timepoint [1] 309770 0
Third month, sixth month and 1st year after the method was started
Secondary outcome [2] 309947 0
Patient satisfaction
Patients will be asked if they are satisfied with the method and if they wish to continue. If they are not pleased the reason will be asked and noted. Special query forms are prepared for the visits.
Timepoint [2] 309947 0
Third month, sixth month and 1st year after the method was started

Eligibility
Key inclusion criteria
Patients who were prescribed oral desogestrel or who were applied levonorgestrel releasing intrauterine device for postpartum contraception
Six weeks passed after vaginal birth and 8 weeks passed after cesarean section
Patients giving consent for the participation to the study
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of acute artery or vein thrombosis
6 months passed after the delivery
Women with acute or chronic liver disease, diabetes, hypertension or renal disease
Women having postpartum depressive symptoms
Patients who won't give consent for the participation

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
For the target sample size power analyses was performed. For a bleeding difference of 30%, 47 patients in each group are requested with a power of 80%. Regarding a drop out rate of at least %20, 56 patients in each group are planned for recruiment.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/09/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
112
Accrual to date
Final
Recruitment outside Australia
Country [1] 6274 0
Turkey
State/province [1] 6274 0
Ankara

Funding & Sponsors
Funding source category [1] 289716 0
Self funded/Unfunded
Name [1] 289716 0
No funding exist
Country [1] 289716 0
Primary sponsor type
Individual
Name
Mine Kiseli
Address
Ufuk University Medical School Mevlana Bulvari No:86 06540 Balgat Ankara
Country
Turkey
Secondary sponsor category [1] 288410 0
None
Name [1] 288410 0
Address [1] 288410 0
Country [1] 288410 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291454 0
Ankara University Faculty of Medicine Ethics Committee
Ethics committee address [1] 291454 0
Ankara University Faculty of Medicine, Morfoloji Yerleskesi, 06100 Sihhiye/ Ankara
Ethics committee country [1] 291454 0
Turkey
Date submitted for ethics approval [1] 291454 0
15/05/2013
Approval date [1] 291454 0
13/01/2014
Ethics approval number [1] 291454 0

Summary
Brief summary
This observational study aims to investigate and compare the menstrual bleeding patterns in patients taking desogestrel or levonorgestrel releasing intrauterine device as postpartum contraceptive method. Secondary purpose is comparing patient satisfaction and side effects concerning these two contraceptive methods. Follow up time will be one year.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50462 0
Dr Mine Kiseli
Address 50462 0
Ufuk University Faculty of Medicine, Department of Obstetrics and Gynecology
Mevlana Bulvari No:86
06540 Balgat/ Ankara
Country 50462 0
Turkey
Phone 50462 0
+90 312 2044318 (Ankara, Turkey)
Fax 50462 0
Email 50462 0
[email protected]
Contact person for public queries
Name 50463 0
Dr Mine Kiseli
Address 50463 0
Ufuk University Faculty of Medicine, Department of Obstetrics and Gynecology
Mevlana Bulvari No:86
06540 Balgat/ Ankara
Country 50463 0
Turkey
Phone 50463 0
+90 312 2044318 (Ankara/ Turkey)
Fax 50463 0
Email 50463 0
[email protected]
Contact person for scientific queries
Name 50464 0
Dr Mine Kiseli
Address 50464 0
Ufuk University Faculty of Medicine, Department of Obstetrics and Gynecology
Mevlana Bulvari No:86
06540 Balgat/ Ankara
Country 50464 0
Turkey
Phone 50464 0
+90 312 2044318 (Ankara/ Turkey)
Fax 50464 0
Email 50464 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data wouldn't be shared because of the privacy and ethical considerations.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.