Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001122347p
Ethics application status
Submitted, not yet approved
Date submitted
2/05/2017
Date registered
31/07/2017
Date last updated
2/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of vaginal Bromocriptine in controlling Adenomyosis symptoms
Scientific title
The Effect of vaginal Bromocriptine in controlling Adenomyosis symptoms
Secondary ID [1] 291809 0
none
Universal Trial Number (UTN)
U1111-1196-1414
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
symptomatic adenomyosis 303052 0
Condition category
Condition code
Reproductive Health and Childbirth 302509 302509 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
vaginal bromocriptine suppository 0.5 mg twice daily inserted by patient for six months, the patient will be phoned monthly to monitor adherence to the intervention
Intervention code [1] 297924 0
Treatment: Drugs
Comparator / control treatment
All women will be assigned after computer randomization to either one of the two treatment protocols: group A) vaginal bromocriptine suppository 0.5 mg twice daily inserted by patient for six months or group B) vaginal Placebo suppository twice daily inserted by patient for the same period
Control group
Placebo

Outcomes
Primary outcome [1] 301921 0
Cycle regularity ,defined as bleeding duration 3-7 days comes every 24-32 days
assessed by cycle diary maintained by participants.
Timepoint [1] 301921 0
6 months
Primary outcome [2] 302451 0
change in pain assessed by visual analogue scale
Timepoint [2] 302451 0
6 months
Secondary outcome [1] 334278 0
1-Time elapsed per days, from start of treatment until patient feel change in pain score using visual analogue score and or cycle regularity achieved according to patient cycle diary .
Timepoint [1] 334278 0
6 months
Secondary outcome [2] 336058 0
Drug side effects .
for example : headache ,nausea ,vomiting , drowsiness, vaginal dryness or irritation as yes or no outcome registered in patient s diary .
Timepoint [2] 336058 0
6months
Secondary outcome [3] 336059 0
change of size of uterus assessed by trans-vaginal ultrasound.
Timepoint [3] 336059 0
6 months
Secondary outcome [4] 336929 0
size of localized adenomyotic patch and vascularity around assessed by transvaginal ultrasound.
Timepoint [4] 336929 0
6 months

Eligibility
Key inclusion criteria
women complaining of symptoms related to presence of adenomyosis like dysmenorrhea, menstrual irregularities and or subfertility.
Minimum age
23 Years
Maximum age
49 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1-Patients on hormonal or intrauterine device as contraception
2-Active pelvic infection
3- Pregnant or breast fed women
4-Hypersenstivity or contraindication to bromocriptine,
5-local contraception users

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)
Allocation is not concealed"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Description of quantitative variables as mean, SD and range,independent T-test will used to compare qualitative variables between groups., Description of qualitative variables as number and percentage Chi-square test was used to compare qualitative variables between groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/02/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
68
Accrual to date
Final
Recruitment outside Australia
Country [1] 8857 0
Egypt
State/province [1] 8857 0
cairo

Funding & Sponsors
Funding source category [1] 296312 0
Hospital
Name [1] 296312 0
Alazhar university hospital
Country [1] 296312 0
Egypt
Primary sponsor type
Individual
Name
Nahed ezzat allam
Address
AlAzhar university hospital
Almostashfa elyuonani street ,abassia
cairo-Egypt
postcode 11651
Country
Egypt
Secondary sponsor category [1] 295238 0
None
Name [1] 295238 0
Address [1] 295238 0
Country [1] 295238 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 297541 0
Al Azhar University ethics committee
Ethics committee address [1] 297541 0
Almostashfa elyuonani street ,abassia
cairo,Egypt
Postcode:11651
Ethics committee country [1] 297541 0
Egypt
Date submitted for ethics approval [1] 297541 0
01/07/2017
Approval date [1] 297541 0
Ethics approval number [1] 297541 0
Ethics committee name [2] 298194 0
Islamic center for population and research
Ethics committee address [2] 298194 0
Alazhar university
Adarrasa
Cairo,egypt
Ethics committee country [2] 298194 0
Egypt
Date submitted for ethics approval [2] 298194 0
02/10/2017
Approval date [2] 298194 0
Ethics approval number [2] 298194 0

Summary
Brief summary
Hysterectomy (removal of womb and ovaries)considered the most common treatment for symptomatic adenomyosis. However due to its association with perioperative , postoperative morbidity, decreased quality of life and high healthcare costs,it looks wise to find another non surgical treatment. Hysterectomy is also not appropriate for women who wish to preserve their fertility and availability of a noninvasive approach for the treatment of adenomyosis may be preferable for most women and could reduce the burden on healthcare systems by a major reduction in surgical intervention. Untill now no proved evidence for any mode of treatment. this study tried to find appropriate medical treatment for this problem.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74378 0
Dr Nahed Allam
Address 74378 0
Alzhraa university hospital
almostashfa alyounani street,abassia
Postcode:11651
Country 74378 0
Egypt
Phone 74378 0
+201229121089
Fax 74378 0
Email 74378 0
nahedallam16@gmail.com
Contact person for public queries
Name 74379 0
Dr Nahed Allam
Address 74379 0
Alzhraa university hospital
almostashfa alyounani street,abassia
Cairo,egypt
postcode :11651
Country 74379 0
Egypt
Phone 74379 0
+201229121089
Fax 74379 0
Email 74379 0
nahedallam16@gmail.com
Contact person for scientific queries
Name 74380 0
Dr nahed allam
Address 74380 0
Alzhraa university hospital
Almostashfa alyounani street,abassia
Cairo,egypt
postcode:11651
Country 74380 0
Egypt
Phone 74380 0
+201229121089
Fax 74380 0
Email 74380 0
nahedallam16@gmail.com

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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