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Search / Trial NCT04256200

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

Launched by AMERICAN UNIVERSITY OF BEIRUT MEDICAL CENTER · Feb 3, 2020

Trial Information

Current as of May 19, 2025

Unknown status

Keywords

Endometriosis Oral Contraceptive Pills Progestin

ClinConnect Summary

Endometriosis is defined as the presence of endometrial tissue outside the uterus, which induces a chronic inflammatory reaction. It is an estrogen-dependent associated with pelvic pain and infertility. It is a relatively common chronic gynecological disease that affects approximately 10% of reproductive aged women. Patients with endometriosis often suffer from dysmenorrhea, dyspareunia, dysuria, and chronic abdominal or pelvic pain, resulting in a severely limited quality of life. The aim of most medical therapies is to alleviate the severity of symptoms. Commonly used hormonal therapies i...

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Patients confirmed or suspected of endometriosis on clinical evaluation (VAS score more than 5 and presence of subjective symptoms), surgical or imaging studies, and not taking any pain killer or other hormonal treatment for the moment
  • Age 20-45
  • Regular menstrual cycles
  • The presence of subjective symptoms during menstruation (at least one from among lower abdominal pain, lumbago, defecation pain, nausea, and headache)
  • The presence of subjective symptoms during non-menstruation (at least one from among lower abdominal pain, lumbago, defecation pain, dyspareunia, and pain on internal examination).
  • Exclusion Criteria:
  • Undiagnosed genital bleeding
  • Use of any hormonal therapy for endometriosis within 16 weeks before enrollment
  • A history of severe adverse drug reactions or hypersensitivity to steroid hormone
  • Having undergone surgery therapy or surgical examination for endometriosis within a menstrual cycle before the start of medication
  • Previous failure of treatment with the OCP used in the current study
  • Contraindications to OCP or Dienogest use
  • Smokers \>35
  • A history or complication of thrombosis/embolism
  • Migraines with aura
  • Depression
  • Patients on anti-epileptics
  • Diabetes Mellitus with vascular involvement
  • Liver diseases
  • Known or suspected sex hormone dependent malignancies
  • Repeat surgery for endometriosis
  • Patient consulting for infertility
  • Pregnant or nursing
  • Planning for pregnancy in near future.

About American University Of Beirut Medical Center

The American University of Beirut Medical Center (AUBMC) is a leading academic medical institution in the Middle East, dedicated to advancing healthcare through innovative research, education, and clinical excellence. As a prominent sponsor of clinical trials, AUBMC integrates cutting-edge scientific inquiry with patient-centered care to enhance therapeutic options and improve health outcomes. With a commitment to ethical standards and regulatory compliance, AUBMC collaborates with multidisciplinary teams to conduct rigorous trials that contribute to the global medical knowledge base and address critical health challenges in the region and beyond.

Locations

Beirut, , Lebanon

Patients applied

0 patients applied

Trial Officials

Antoine Abu Musa, MD

Principal Investigator

American University of Beirut Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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