Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001055897
Ethics application status
Approved
Date submitted
28/09/2012
Date registered
3/10/2012
Date last updated
3/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of therapeutic efficacy of two different medical treatments and hormone releasing intrauterine device in treatment of heavy uterine bleeding
Scientific title
Comparison of therapeutic efficacy of norethisterone, tranexamic acid and levonorgestrel releasing intrauterine system in treatment of dysfunctional uterine bleeding
Secondary ID [1] 281317 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heavy menstrual bleeding defined by PBAC scores 287519 0
Condition category
Condition code
Reproductive Health and Childbirth 287843 287843 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We planned to divide the study group into three groups:
Arm 1: Oral norethisterone in 15mg/day (3x5 mg) dose for 10 days between 14th and 23th day of the menstrual cycle; the treatment will be given for 6 menstrual cycles
Arm 2: Oral tranexamic acid 4 mg/day (4x1 mg) for the first four days of the menstrual cycle; the treatment will be given for 6 menstrual cycles
Arm 3: Levonorgestrel releasing intrauterine system which releases 20 microgram levonorgestrel /day, will be applied during the 4-5th day of the menstrual cycle by the physician. The system remains in place for at least 6 months, if the patient is satisfied with the system, it will go on for 5 years.
Intervention code [1] 285772 0
Treatment: Drugs
Comparator / control treatment
Comparison of three groups is planned
Control group
Active

Outcomes
Primary outcome [1] 288064 0
Decrease in menstrual blood loss measured as PBAC scores described by Higham.
Timepoint [1] 288064 0
Patients with PBAC scores>100 were included. At 1st, 3rd and 6th month PBAC scores were measured
Secondary outcome [1] 299361 0
Hemoglobin, hematocrit levels
Timepoint [1] 299361 0
Basal, at 3rd and 6th months of treatment
Secondary outcome [2] 299362 0
Ferritin, serum iron and iron binding capacity
Timepoint [2] 299362 0
Basal, at 3rd and 6th months of treatment
Secondary outcome [3] 299363 0
Quality of Life evaluation by the World Health Organization Quality of Life-Short Form
Timepoint [3] 299363 0
Before the study, at the end of 6 months of treatment

Eligibility
Key inclusion criteria
Regularly menstruating patients in the reproductive period, other than adolescents
Patients with mean PBAC scores of two menstrual periods greater than 100
Premenopausal women
Patients with benign endometrial biopsy
Patients who were willing to participate in the study
Patients with fibroids smaller than 2 cm, not distorting the endometrial cavity
Minimum age
20 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Malign Cervical cytology
Contraindications to current therapies
Systemic diseases like hypertension, diabetes, thyroid disease or coronary artery disease
Women having used steroid hormone or anticoagulants during last three months or hormonal contraceptive injection during last year

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment outside Australia
Country [1] 4573 0
Turkey
State/province [1] 4573 0

Funding & Sponsors
Funding source category [1] 286072 0
Self funded/Unfunded
Name [1] 286072 0
Mine Kiseli
Country [1] 286072 0
Turkey
Primary sponsor type
Individual
Name
Mine Kiseli
Address
Mesa Park Sit. Sogut Blok No:12/18 06490 Oran Ankara
Country
Turkey
Secondary sponsor category [1] 284887 0
Individual
Name [1] 284887 0
Ozlem Ozdegirmenci
Address [1] 284887 0
Etlik Zubeyde Hanim Maternity and Women Health Education and Research Hospital
Asagi Eglence Mah., Yeni Etlik Cad., 06010 Etlik (Incirli)
Ankara
Country [1] 284887 0
Turkey

Ethics approval
Ethics application status
Approved

Summary
Brief summary
We planned to evaluate and compare the effectiveness of norethisterone, tranexamic acid and Levonorgestrel Releasing Intaruterine System in regular heavy menstrual bleeding in reproductive age women. Mean PBAC scores of two periods > or equal to 100 was accepted as 80 mL blood loss and defined as menorrhagia. 66 patients with menorrhagia without organic patologies were enrolled into the study. Patients are divided into three treatment arms sequentially; oral norethisterone, oral tranexamic acid and Levonorgestrel releasing intrauterine system. During 6 months of therapy PBAC scores were recorded by the patients and decrease in PBAC scores at 1st, 3rd and 6th month as well as hemoglobin, hematocrit, serum iron and ferritin levels was measured. Quality of life assessment forms in World Health Organization Quality of Life Short Form, Turkish version which was translated from the original English version, were filled up before and at the end of the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34763 0
Address 34763 0
Country 34763 0
Phone 34763 0
Fax 34763 0
Email 34763 0
Contact person for public queries
Name 18010 0
Mine Kiseli
Address 18010 0
Mesa Park Sit. Sogut Blok No:12/18 06490 Oran Ankara
Country 18010 0
Turkey
Phone 18010 0
+90 532 5080110
Fax 18010 0
Email 18010 0
[email protected]
Contact person for scientific queries
Name 8938 0
Mine Kiseli
Address 8938 0
Mesa Park Sit. Sogut Blok No:12/18 06490 Oran Ankara
Country 8938 0
Turkey
Phone 8938 0
+90 532 5080110
Fax 8938 0
Email 8938 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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