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Trial registered on ANZCTR


Registration number
ACTRN12617001021369
Ethics application status
Approved
Date submitted
10/11/2016
Date registered
14/07/2017
Date last updated
9/11/2018
Date data sharing statement initially provided
9/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Pentoxifylline versus progesterone medicated intrauterine device in controlling pain and increased menstrual blood flow of women with adenomyosis
Scientific title
Progesterone impregnated IUD versus pentoxifylline in management of women with symptomatic adenomyosis
Secondary ID [1] 290504 0
none
Universal Trial Number (UTN)
U1111-1189-6654
Trial acronym
AMT (Adenomyosis management trial )
Linked study record
NOne

Health condition
Health condition(s) or problem(s) studied:
dysmenorrhea 300900 0
chronic pelvic pain 300901 0
menorrhagia 300902 0
adenomyosis 303210 0
Condition category
Condition code
Reproductive Health and Childbirth 303072 303072 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Levonorgestrel medicated intrauterine device contain 52 mg of levonorgestrel , will be inserted by consultant ,as simple outpatient procedure . progestin provide a release rate of approximately 20mcg/day. It still reactive for five years, patient adherence checked one month then three months after insertion and every one year visit.
Intervention code [1] 296362 0
Treatment: Drugs
Comparator / control treatment
pentoxifylline oral tab(trental 200mg) twice daily for 3 months a phosphodiesterase inhibitor as angiogenesis inhibitors
Control group
Active

Outcomes
Primary outcome [1] 300133 0
dysmenorrhea pain measured by visual analogue score
Timepoint [1] 300133 0
baseline and 3 months post treatment commencement
Primary outcome [2] 300134 0
chronic pelvic pain,measured by visual analogue score
chronic pelvic pain means pain at lower abdominal pain last for six months or more.
Timepoint [2] 300134 0
baseline and 3 months post treatment commencement
Secondary outcome [1] 329167 0
menorrhagia,measured by hemoglobin deficit
hemoglobin deficit calculated by subtraction of baseline haemoglobin in grams from hemoglobin level 3 months post treatment commencement.
Timepoint [1] 329167 0
baseline and 3 months post treatment commencement
Secondary outcome [2] 329168 0
metrorrhagia
its uterine bleeding at irregular periods (yes or no catigorical variable)
Timepoint [2] 329168 0
baseline and 3 months post treatment commencement
Secondary outcome [3] 329169 0
numberof localized adenomyosis,measured by transvaginal ultrasound
Timepoint [3] 329169 0
baseline and 3 months post treatment commencement
Secondary outcome [4] 330358 0
uterine volume measured by transvaginal ultrasound
measured in cubic cm
Timepoint [4] 330358 0
baseline and 3 months post treatment commencement
Secondary outcome [5] 336060 0
volume of localized adenomyosis,measured by transvaginal ultrasound
volume measured in cubic cm
Timepoint [5] 336060 0
3 months

Eligibility
Key inclusion criteria
Women with symptomatic adenomyosis (menstrual irregularities –pain-subfertility):
1- Age more 30 years and less than 50.
2- Patients not seeking for fertility.
3- Patients were seeking an alternative to hysterectomy
Minimum age
30 Years
Maximum age
50 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Uterine fundal level more than 20cm above symphysis pubis
2. Active pelvic infection or current use of contraceptive
3. Contraindication for medications


Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using coin-tossing
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
none
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Sample size calculation done by statistician using G*Power 3.0.10 software assuming that type I alpha error 0.05 and type Beta error 0.8 with confidence interval 80% and actual power 80% .
35 patients will be randomly distributed in each group.

Recruitment
Recruitment status
Recruiting
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] 8381 0
Egypt
State/province [1] 8381 0
cairo

Funding & Sponsors
Funding source category [1] 294921 0
Hospital
Name [1] 294921 0
alzahraa university hospital
Address [1] 294921 0
Elmostashfa elyounany street ,abassia
Cairo, Egypt
postcode 11651
Country [1] 294921 0
Egypt
Primary sponsor type
Individual
Name
nahed allam
Address
AlAzhar university hospital
4Dawood barakat street
nasr city ,cairo
Egypt
Country
Egypt
Secondary sponsor category [1] 293757 0
None
Name [1] 293757 0
Address [1] 293757 0
Country [1] 293757 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296299 0
Ethical and Research and approval by local ethical committee of OB/ Gyn department -AlAzhar university
Ethics committee address [1] 296299 0
5 Alyonani hospital street
Elabassia ,cairo -Egypt
Ethics committee country [1] 296299 0
Egypt
Date submitted for ethics approval [1] 296299 0
04/05/2016
Approval date [1] 296299 0
10/06/2016
Ethics approval number [1] 296299 0
4863185

Summary
Brief summary
Adenomyosis refers to a disorder in which glands lining the womb cavity present within the uterine musculature (uterine adenomyomatosis). The ectopic glandular tissue appears to induce thickening of the surrounding musculaure, which results in a diffusely enlarged womb.The medical treatment of adenomyosis is based on the hormonal dependency of the disease and its strongly share similarities with endometriosis,Two novel techniques will improve medical treatment over the next few years and even produce a preventive strategy: the first are new blood vessels inhibitors and the second is the progesterone-releasing intrauterine device

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70342 0
Dr Nahed Ezzat Allam
Address 70342 0
AlAzhar university hospital
4 Dawood Barakat street ,
nasr city,cairo
Egypt
Country 70342 0
Egypt
Phone 70342 0
+201229121089
Fax 70342 0
Email 70342 0
nahedallam16@gmail.com
Contact person for public queries
Name 70343 0
Dr Nahed Ezzat Allam
Address 70343 0
AlAzhar university hospital
4 Dawood Barakat street ,
nasr city,cairo
Egypt
Country 70343 0
Egypt
Phone 70343 0
+201229121089
Fax 70343 0
Email 70343 0
nahedallam16@gmail.com
Contact person for scientific queries
Name 70344 0
Dr Taiseer Maarouf
Address 70344 0
AlAzhar university hospital
street 9 ,Almokatum,cairo
Egypt
Country 70344 0
Egypt
Phone 70344 0
+201223660078
Fax 70344 0
Email 70344 0
taiseer.maarouf@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Summary results
No Results