Brief Title
Dienogest for Treatment of Adenomyotic Uteri
Official Title
Dienogest Versus a Low-dose Combined Oral Contraceptive for Treatment of Adenomyotic Uteri
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
Study Type
Interventional
Primary Outcome
Number of women who will improved from the pelvic pain measured by visual analogue scale
Secondary Outcome
Uterine volume (cm 3 ) measure by ultrasound
Condition
Adenomyosis
Intervention
Dienogest group
Study Arms / Comparison Groups
Dienogest group
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
100
Start Date
March 1, 2019
Completion Date
August 1, 2020
Primary Completion Date
July 1, 2020
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 .
Gender
Female
Ages
20 Years - 40 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Egypt
Location Countries
Egypt
Administrative Informations
NCT ID
NCT03890042
Organization ID
DAD
Responsible Party
Principal Investigator
Study Sponsor
Assiut University
Study Sponsor
, ,
Verification Date
August 2020