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Trial registered on ANZCTR


Registration number
ACTRN12614000015640
Ethics application status
Approved
Date submitted
16/12/2013
Date registered
7/01/2014
Date last updated
7/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intrauterine Levonorgestrel Device in Patients with Endometriosis
Scientific title
The evaluation of changes in symptoms and findings of endometriosis patients with intrauterine levonorgestrel device
Secondary ID [1] 283777 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clinically symptoms of endometriosis 290752 0
dysmenorrhea 290753 0
dyspareunia 290839 0
Condition category
Condition code
Reproductive Health and Childbirth 291114 291114 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
we inserted Levonorgestrel Intrauterin System(Lng-IUS) women aged between 23-48 with suspected symptomatic endometriosis. The procedure lasted about 2 minutes. Once it is inserted it stays in the uterus for 12 months untill the study is terminated. It is not inserted-reinserted, but inserted just once. The total intervention lasted for 12 months; the total duration of the study and continued after the study unless the patient desired otherwise.
Intervention code [1] 288469 0
Treatment: Devices
Comparator / control treatment
no control teatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291106 0
To measure improvements in severity and frequency of pain. Each patient was asked to complete questioannaries of SF-36 and visual analogue scales (VAS) in the first visit and 3rd, 6th, 9th and 12th months of the study. These scales recorded the non-cyclic pain, dysmenorrhoea, severity of dyspareunia symptoms effects on life quality and degree of satisfaction after treatment.
Timepoint [1] 291106 0
The patients were assessed physically, sonographically and mentally at the beginning of the study and then periodically after the first visit at the 3rd, 6th, 9th and 12th months of the study.
Secondary outcome [1] 306006 0
Serum CA-125 levels were measured in the plasma samples of each participant by the laborotory. Changes in the Ca-125 levels were noted accordingly.
Timepoint [1] 306006 0
patients assessed every 3 months for a total of 12 months period.
Secondary outcome [2] 306211 0
The menstrual symptoms such as noncyclic bleeding, menorrhagia, acnes, mood swings were each evaluated by patient questionnaires in each visit.
Timepoint [2] 306211 0
The participants were assessed every 3 months for a total of 12 months period.

Eligibility
Key inclusion criteria
All women have endometriosis symptoms. All of the women had regular menstrual periods (25–35 day intervals) for at least 6 months before particapting in the study, had not used any hormonal therapy for at least 6 months prior to the study. None of the women had been breastfeeding or had a desire to conceive in the ensuing 12 months. They had no history of osteoporosis, coagulation disorders, or contraindications to LNG-IUS.
Minimum age
23 Years
Maximum age
48 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria included non-diagnosed vaginal bleeding, gynecological cancer history, chronical diseases such as liver pathologies or diabetes mellitus, pelvic inflammatory disease, septic abortion history in the last 3 months, malignancy doubt in biopsies, fertility desire, the uterus size bigger than 10 weeks of gestational age, submucosal leiomyoma or polyp, having a diagnosis of a gynecologycal pathology other than endometriosis and a history of hormonal medication usage in the last 3 months.

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
Single group
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
The cross sectional study was conducted with patients who had showed up in our clinic for endometriosis treatment for the specific 2 years we planned our study interval. We also kept in mind the number of patients that the other studies participated considering this subject.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5683 0
Turkey
State/province [1] 5683 0

Funding & Sponsors
Funding source category [1] 288442 0
University
Name [1] 288442 0
Istanbul Medeniyet University
Address [1] 288442 0
Kadin Hastaliklari ve Dogum Bolumu
Fahrettin Kerim Gokay s.
Kadikoy Istanbul-Turkey-34722
Country [1] 288442 0
Turkey
Primary sponsor type
University
Name
Istanbul Medeniyet University Goztepe Education and Research Hospital
Address
Kadin Hastaliklari ve Dogum Bolumu
Fahrettin Kerim Gokay s.
Kadikoy Istanbul-Turkey-34722
Country
Turkey
Secondary sponsor category [1] 287144 0
Hospital
Name [1] 287144 0
Goztepe Educational and Research Hospital
Address [1] 287144 0
Kadin Hastaliklari ve Dogum Bolumu
Fahrettin Kerim Gokay s Kadikoy Istanbul-Turkey-34722
Country [1] 287144 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290368 0
istanbul medeniyet university Goztepe educational and research hospital
Ethics committee address [1] 290368 0
Fahrettin Kerim Gokay s.
Kadikoy Istanbul-Turkey-34722
Ethics committee country [1] 290368 0
Turkey
Date submitted for ethics approval [1] 290368 0
15/02/2011
Approval date [1] 290368 0
05/04/2011
Ethics approval number [1] 290368 0
11/L

Summary
Brief summary
Our study showed that Levonorgestrel Intrauterine System improved the severity and frequency of pain, life quality assessment test scores, serum CA-125 levels and menstrual symptoms of patients with endometriosis.
Trial website
Trial related presentations / publications
Lockhat FB, Emembolu JO and Konje JC. The efficacy, side-effects and continuation rates in women with symptomatic endometriosis undergoing treatment with an intra-uterine administered progestogen (levonorgestrel): a 3 year follow-up.
Human Reproduction 2005;l.20(3):789–793
Public notes

Contacts
Principal investigator
Name 45026 0
A/Prof Gokhan Goynumer
Address 45026 0
SB Istanbul Medeniyet Universitesi, Goztepe Egitim ve Arastirma Hastanesi
Kadin Hastaliklari ve Dogum Bolumu
Fahrettin Kerim Gokay s.
Kadikoy Istanbul-Turkey-34722
Country 45026 0
Turkey
Phone 45026 0
+905326119396
Fax 45026 0
Email 45026 0
goynumergo@gmail.com
Contact person for public queries
Name 45027 0
A/Prof Gokhan Goynumer
Address 45027 0
SB Istanbul Medeniyet Universitesi, Goztepe Egitim ve Arastirma Hastanesi
Kadin Hastaliklari ve Dogum Bolumu
Fahrettin Kerim Gokay s.
Kadikoy Istanbul-Turkey-34722

Country 45027 0
Turkey
Phone 45027 0
+905326119396
Fax 45027 0
Email 45027 0
goynumergo@gmail.com
Contact person for scientific queries
Name 45028 0
A/Prof Gokhan Goynumer
Address 45028 0
SB Istanbul Medeniyet Universitesi, Goztepe Egitim ve Arastirma Hastanesi
Kadin Hastaliklari ve Dogum Bolumu
Fahrettin Kerim Gokay s.
Kadikoy Istanbul-Turkey-34722
Country 45028 0
Turkey
Phone 45028 0
+905326119396
Fax 45028 0
Email 45028 0
goynumergo@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary