Dienogest for Treatment of Adenomyotic Uteri
Primary Purpose
Adenomyosis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dienogest group
Gestodene-Ethinyl Estradiol
Ultrasound
visual analogue scale
Sponsored by
About this trial
This is an interventional treatment trial for Adenomyosis
Eligibility Criteria
Inclusion Criteria:
- Women aged 20-40 years
- Women with ultrasonographic evidence of adenomyosis
- Woman complains of vaginal bleeding or pelvic pain related to adenomyosis
Exclusion Criteria:
- Women with a history of malignancy or histological evidence of endometrial hyperplasia
- any adnexal abnormality on ultrasound
- undiagnosed vaginal
- contraindication to receive Vissane or gynera .
Sites / Locations
- Women Health Hospital - Assiut university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Dienogest group
Gynera group
Arm Description
Outcomes
Primary Outcome Measures
Number of women who will improved from the pelvic pain measured by visual analogue scale
Secondary Outcome Measures
Uterine volume (cm 3 ) measure by ultrasound
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03890042
Brief Title
Dienogest for Treatment of Adenomyotic Uteri
Official Title
Dienogest Versus a Low-dose Combined Oral Contraceptive for Treatment of Adenomyotic Uteri
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)
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 is a common disease in women aged 40-50 years. It associates with dysmenorrhea and menorrhagia. Hysterectomy was considered the main treatment that could definitively cure this disease. Other treatment options are increasingly offered, including hormonal suppression with gonadotropin-releasing hormone agonists or danazol and endometrial ablation. However, deep adenomyosis responds weakly to the above treatment options, which are commonly not considered for long-term management because of the associated side effects.
Dienogest is a progestin medication which is used in birth control pills and in the treatment of endometriosis and adenomyosis. Low-dose combined oral contraceptive (COC) pills have been widely used as the primary treatment for menorrhagia. COCs can also be used to induce endometrial atrophy and to decrease endometrial prostaglandin production, which can consequently improve menorrhagia and dysmenorrhea that are associated with adenomyosis
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
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dienogest group
Arm Type
Active Comparator
Arm Title
Gynera group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dienogest group
Intervention Description
VISANNE 2MG Tablet once daily
Intervention Type
Drug
Intervention Name(s)
Gestodene-Ethinyl Estradiol
Intervention Description
Gynera tablet once daily
Intervention Type
Radiation
Intervention Name(s)
Ultrasound
Intervention Description
ultrasound assessment of uterine volume
Intervention Type
Other
Intervention Name(s)
visual analogue scale
Intervention Description
visual analogue scale for assessment of pain
Primary Outcome Measure Information:
Title
Number of women who will improved from the pelvic pain measured by visual analogue scale
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Uterine volume (cm 3 ) measure by ultrasound
Time Frame
6 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women aged 20-40 years
Women with ultrasonographic evidence of adenomyosis
Woman complains of vaginal bleeding or pelvic pain related to adenomyosis
Exclusion Criteria:
Women with a history of malignancy or histological evidence of endometrial hyperplasia
any adnexal abnormality on ultrasound
undiagnosed vaginal
contraindication to receive Vissane or gynera .
Facility Information:
Facility Name
Women Health Hospital - Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
33454995
Citation
Hassanin AI, Youssef AA, Yousef AM, Ali MK. Comparison of dienogest versus combined oral contraceptive pills in the treatment of women with adenomyosis: A randomized clinical trial. Int J Gynaecol Obstet. 2021 Aug;154(2):263-269. doi: 10.1002/ijgo.13600. Epub 2021 Feb 11.
Results Reference
derived
Learn more about this trial
Dienogest for Treatment of Adenomyotic Uteri
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