| 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
|
|
|
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
|
|
|
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. |