drugset / Trial / NCT04256200

Efficacy of Dienogest Versus Oral Contraceptive Pills on Pain Associated With Endometriosis

NCT04256200

Phase 2/3 Unknown 100 enrolled American University of Beirut Medical Center
RandomizedParallel-groupDouble-blindTreatment

Summary

Endometriosis is a chronic inflammatory disease, frequently associated with dysmenorrhea, dyspareunia and abdomino-pelvic pain limiting quality of life. Most medical therapies aim to alleviate the severity of symptoms. Recent guidelines recommend the use of either OCPs or progestins as a first-line treatment of pain associated with endometriosis. The effectiveness of both OCPs and dienogest, a fourth-generation progestin, for endometriosis treatment has been demonstrated. The literature is rich with data comparing the use of Visanne or OCPs to placebo or GnRH analogs. However, there are no head to head studies comparing their efficacy in the management of endometriosis associated pain. The study aims to evaluate if Dienogest (Visanne) is not inferior in efficacy to oral contraceptive pills (Yasmin) in controlling pain associated with endometriosis?

Timeline

Start
2017-02-07
Primary completion
2021-11
Completion
2021-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dienogest Small molecule 2 mg Oral
Comparator drospirenone Unknown 3 mg Oral
Comparator ethinyl estradiol Small molecule 0.03 mg Oral

Indications