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

NCT04256200 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-04-15

No results posted yet for this study

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?

Conditions

  • Endometriosis

Interventions

DRUG

Dienogest 2 MG Oral Tablet

Deinogest (Visanne) 2mg/day, orally for 24 weeks versus combined OCP (Yasmin, 0.03mg

DRUG

Yasmin

0.03mg Ethinyl Estradiol and 3mg Drospirenone daily for 24 weeks

Sponsors & Collaborators

  • American University of Beirut Medical Center

    lead OTHER

Principal Investigators

  • Antoine Abu Musa, MD · American University of Beirut Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-07
Primary Completion
2021-11-30
Completion
2021-12-31

Countries

  • Lebanon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04256200 on ClinicalTrials.gov