Dienogest for Treatment of Adenomyotic Uteri
Dienogest Versus a Low-dose Combined Oral Contraceptive for Treatment of Adenomyotic Uteri
1 other identifier
interventional
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2019
CompletedFirst Submitted
Initial submission to the registry
March 23, 2019
CompletedFirst Posted
Study publicly available on registry
March 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedAugust 25, 2020
August 1, 2020
1.3 years
March 23, 2019
August 22, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Number of women who will improved from the pelvic pain measured by visual analogue scale
6 months
Secondary Outcomes (1)
Uterine volume (cm 3 ) measure by ultrasound
6 month
Study Arms (2)
Dienogest group
ACTIVE COMPARATORGynera group
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Women aged 20-40 years
- Women with ultrasonographic evidence of adenomyosis
- Woman complains of vaginal bleeding or pelvic pain related to adenomyosis
You may not qualify if:
- 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 .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Women Health Hospital - Assiut university
Asyut, 71111, Egypt
Related Publications (1)
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.
PMID: 33454995DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
March 23, 2019
First Posted
March 26, 2019
Study Start
March 1, 2019
Primary Completion
July 1, 2020
Study Completion
August 1, 2020
Last Updated
August 25, 2020
Record last verified: 2020-08