| CTRI Number |
CTRI/2024/04/065573 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
11/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of tablet Dienogest versus Combined oral contraceptive pills (OCPs) for relief of pain (Dysmenorrhea or pelvic pain) associated with endometriosis disease |
|
Scientific Title of Study
|
An open label randomized clinical trial to compare the efficacy of Dienogest versus combined oral contraceptive pills (OCPs) using visual analog scale (VAS) for relief of pain associated with Endometriosis |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Ravisha Aggarwal |
| Designation |
Post graduate junior resident Obstetrics and Gynaecology |
| Affiliation |
All india institute of medical sciences Raipur |
| Address |
Department of Obstetrics and Gynaecology first floor b block AIIMS Raipur Tatibandh Chattisgarh 492099
Raipur
CHHATTISGARH
492099
India |
| Phone |
8724831977 |
| Fax |
|
| Email |
ravishaaggarwal2711@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nilaj Kumar Bagde |
| Designation |
Additional professor Obstetrics and Gynaecology |
| Affiliation |
All india institute of medical sciences Raipur |
| Address |
Department of Obstetrics And Gynaecology First floor B block room no.2 AIIMS Raipur Tatibandh CHATTISGARH 492099
Raipur
CHHATTISGARH
492099
India |
| Phone |
8724831977 |
| Fax |
|
| Email |
drnilajbagde@aiimsraipur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DR RAVISHA AGGARWAL |
| Designation |
POST GRADUATE JUNIOR RESIDENT DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR |
| Address |
Department of Obstetrics and Gynaecology First Floor B block AIIMS RAIPUR TATIBANDH CHATTISGARH 492099
Raipur
CHHATTISGARH
492099
India |
| Phone |
8724831977 |
| Fax |
|
| Email |
ravishaaggarwal2711@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Obstetrics and Gynaecology first floor b block AIIMS Raipur Tatibandh Chattisgarh 492099 |
|
|
Primary Sponsor
|
| Name |
Dr Ravisha Aggarwal |
| Address |
Department of Obstetrics and Gynaecology first floor b block AIIMS Raipur Tatibandh Chattisgarh 492099 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ravisha Aggarwal |
All india institute of medical sciences Raipur |
Department of Obstetrics and Gynaecology first floor b block room no.2 .
Raipur
CHHATTISGARH |
8724831977
ravishaaggarwal2711@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethic Committee All India Institute of Medical Sciences Raipur 492099 492099 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drug Dienogest |
Dienogest 2mg daily for 12 weeks |
| Comparator Agent |
Drug-Combined Oral Contraceptive Pills |
Combined Oral Contraceptive Pills (0.03 mg ethinylestradiol and 0.15 mg levonorgestrel ) continously for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patient having diagnosis of endometriosis established by means of documented
surgical visual (laparoscopy/laparotomy) or imaging (USG/MRI) plus
Presence of at least one of the symptoms dysmenorrhea, chronic pelvic pain or both
or dyspareunia for more than 6 months with
- Age: 18–45 years old
- Endometriosis associated pelvic pain scoring more than or equal to 4 On
visual analog scale (VAS) at baseline
- Patients planned for medical management only for atleast 12 weeks
- Women willing to participate for study |
|
| ExclusionCriteria |
| Details |
-Those who underwent surgery for endometriosis in between medical management.
- Undiagnosed genital bleeding or other medical disorder like thyroid, bleeding
disorder, liver and heart disease
- Use of hormonal therapy for endometriosis within 16 weeks before enrolment
including GNRH antagonists, Depot Medroxyprogesterone acetate (DMPA),
progestogens, OCPs or Previously, failed treatment of endometriosis using
medications included in the study
- Pregnancy, lactation, and desire to conceive during treatment period.
- Hypersensitivity to steroid hormones, Contraindications to COC or Dienogest use as
recognized by the World Health Organization and Centers for Disease Control and
Prevention
-Women with acquired/congenital uterine anomaly
- Patient using any systemic steroids (topical steroids allowed) over 14 days or within 3
months.
- Patient has chronic pelvic pain not caused by endometriosis that requires chronic
analgesic or other chronic therapy which could interfere with assessment of pain.
- Patient having positive history of HIV, HCV and HBV or active vaginal infection.
- Patient having history of major depression or other psychiatric disorder (stroke)
- Previous h/o severe life threatening or other significant sensitivity for any drug. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in patient pain symptoms assessed by visual analog pain scale (VAS). |
Every 4 weeks till 12 weeks and after 1 month of stopping drug. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparison of adverse effect of drugs in both the groups.
|
every 4 weeks till 12 weeks & after 1 month of stopping drug |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
22/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study aimed to compare the efficacy and safety profile of Dienogest with Combined
Oral Contraceptive pills for the relief of endometriosis-associated pelvic pain. Dienogest is
a new generation of progestin used in the treatment of endometriosis. Given the chronic
nature of the condition, medical treatments for endometriosis need to balance clinical
efficacy and symptom relief with an acceptable long-term safety profile and OCPS cannot
be taken by very young and older women due to estrogenic side effects or contraindications.
Many recent guidelines have recommended the use of either COCs or progestins as a first
line medical management for pain associated with endometriosis. Also very few studies
have been done to compare the efficacy and safety profile of Dienogest vs Combined Oral
Contraceptive pills |