drugset / Trial / NCT03890042

Dienogest for Treatment of Adenomyotic Uteri

NCT03890042

Completed 100 enrolled Assiut University
RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2019-03-01
Primary completion
2020-07-01
Completion
2020-08-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dienogest Small molecule 2 mg
Comparator Gestodene Small molecule
Comparator ethinyl estradiol Small molecule

Indications