Back to resultsRole of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis
Primary Purpose
Adenomyosis
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dienogest
Combined Oral Contraceptive
Sponsored by
About this trial
This is an interventional treatment trial for Adenomyosis
Eligibility Criteria
Inclusion Criteria:
- symptomatic adenomyosis
- irregular menstrual bleeding and dysmenorrhea .
Exclusion Criteria:
- asymptomatic patients -
- non-lactating patient
- not desire for pregnancy
- no hormonal treatment more than 6 month even contraception e.g IUD
- no focal lesion of uterus (malignancy ,fibroid or adenxal mass )
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Study group
control group
Arm Description
women will receive dienogest
women used combined oral contraceptive pills
Outcomes
Primary Outcome Measures
The mean pain score after receiving treatment
assessment by visual analog scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03654144
Brief Title
Role of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis
Official Title
Role of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2018 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
March 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Adenomyosis was first described as endometrial glands in the myometrium of the uterus. The current definition of adenomyosis is provided in 1972 'the benign invasion of endometrium into the myometrium, producing a diffusely enlarged uterus which microscopically exhibits ectopic non-neoplastic, endometrial glands and stroma surrounded by the hypertrophic and hyperplastic myometrium
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenomyosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
women will receive dienogest
Arm Title
control group
Arm Type
Active Comparator
Arm Description
women used combined oral contraceptive pills
Intervention Type
Drug
Intervention Name(s)
Dienogest
Intervention Description
oral tablets
Intervention Type
Drug
Intervention Name(s)
Combined Oral Contraceptive
Intervention Description
oral tablets
Primary Outcome Measure Information:
Title
The mean pain score after receiving treatment
Description
assessment by visual analog scale
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
symptomatic adenomyosis
irregular menstrual bleeding and dysmenorrhea .
Exclusion Criteria:
asymptomatic patients -
non-lactating patient
not desire for pregnancy
no hormonal treatment more than 6 month even contraception e.g IUD
no focal lesion of uterus (malignancy ,fibroid or adenxal mass )
12. IPD Sharing Statement
Learn more about this trial
Role of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis
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