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CTRI Number  CTRI/2024/02/062618 [Registered on: 14/02/2024] Trial Registered Prospectively
Last Modified On: 13/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Cyclic administration of Dienogest for dysmenorrhea in adenomyosis 
Scientific Title of Study   Efficacy of a cyclic regimen of Dienogest for treatment of adenomyosis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pakhanan Dankamak 
Designation  Resident of obstetrics and gynecology 
Affiliation  Songklanagarind hospital 
Address  Songklanagarind hospital Department of Obstetrics and gynecology Resident room 15 Kanjanawanid road Amphur Hatyai Songkla province 90110 Thailand
-
Not Applicable
N/A
90110
Other 
Phone  6842435867  
Fax  -  
Email  pakhananson@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Saranya Wattanakumtornkul 
Designation  Assistant professor of Obstetrics and Gynecology 
Affiliation  Prince of Songklha University 
Address  Department of Obstetrics and Gynecology, Faculty of Medicine, Prince of Songkla University
-
Not Applicable
N/A
90110
Other 
Phone  66858842988  
Fax  -  
Email  Saranya.w@psu.ac.th  
 
Details of Contact Person
Public Query
 
Name  Pakhanan Dankamak 
Designation  Resident of obstetrics and gynecology 
Affiliation  Songklanagarind hospital 
Address  Songklanagarind hospital Department of Obstetrics and gynecology Resident room 15 Kanjanawanid road Amphur Hatyai Songkla province 90110 Thailand
-
Not Applicable
N/A
90110
Other 
Phone  6842435867  
Fax  -  
Email  pakhananson@gmail.com  
 
Source of Monetary or Material Support  
Songklanagarind hospital 15 Kanjanawanid road, Amphur Hatyai, Songkla province 90110 Thailand 
 
Primary Sponsor  
Name  Songklanagarind hospital 
Address  15 Kanjanawanid road Amphur Hatyai Songkla province 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Thailand  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pakhanan Danakamak  Songklanagarind hospital  Outpatient room Department of obstetrics and gynecology 15 Kanjanawanid road Amphur Hatyai Songkla province 90110 Thailand

 
6842435867

pakhananson@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Research Ethics Committee Faculty of Medicine, Prince of Songkla university  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N800||Endometriosis of uterus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dienogest  12-week course of cyclic regimen of Dienogest is given to all participant (21 days with 2 mg of dienogest starting on the first day of menstrual cycle followed by 7 drug free days, total of 3 cycles) 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1.Adenomyosis is diagnosed by ultrasound
2.Dysmenorrhea with visual analog scale more than 3
3.Woman with regular frequency of menstruation 24-38 days for 3 cycles
4.No pregnancy desire during the treatment and trial period
5.No co-existing endometrioma or myoma or current PID by pelvic examination and ultrasonography  
 
ExclusionCriteria 
Details  1.Contraindication of dienogest
2.Previous hormonal treatment within 3 months or current use
3.History or suspicious of gynecologic malignancy or hormonal responsive tumor
4.Currently breastfeeding
5.Current use of drugs with interaction to cytochrome P450 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the change in visual analog scale (VAS) of dysmenorrhea during treatment women diagnosed with adenomyosis by cyclic regimen of dienogest   3 months 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate patterns and amount of uterine bleeding during treatment with cyclic regimen of dienogest.   3 months 
To evaluate adverse effect of cyclic regimen of dienogest.  3 months 
 
Target Sample Size   Total Sample Size="23"
Sample Size from India="0" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  23/02/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Applicable 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Adenomyosis is a benign uterine disease which causes disturbing symptoms for premenopausal women. The common two symptoms are dysmenorrhea and heavy menstrual bleeding which can be severe and impair quality of life. The etiology of adenomyosis is suspected from the endometrial gland and stromal that invade uterine myometrium which cause pain symptom and heavy bleeding on menstruation.

Dienogest is the fourth generation of oral progestogen which can cause endometrial decidualization and atrophy. Several previous studies stated that continuous regimen of dienogest was efficacious to treat adenomyosis in terms of reducing dysmenorrhea and heavy menstrual bleeding. However, dienogest has also been shown to have high undesirable side effects. Irregular bleeding or spotting is the main side effect which can be found in more than half of the patients and leads to discontinuation of treatment.

Cyclic regimen of dienogest, 3-week period with 1-week withdrawal period, to reduce irregular bleeding during treatment of endometriosis was evaluated. It could significantly ameliorate the menstrual pain compared with that before treatment and also resulted in high occurrence of menstrual-lilke bleeding during the drug withdrawal period with less number of days of irregular bleeding. However, the efficacy of a cyclic regimen of dienogest has not yet been studied for treatment of adenomyosis. Many of the pathophysiology of adenomyosis and endometriosis is quite similar. Both are originated from eutopic endometrium having somatic mutation and migrating to different sites e.g. peritoneal surface, ovary or myometrium. Therefore, this study aims to evaluate the efficacy of a cyclic regimen of dienogest for treatment of adenomyosis.

 
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