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

NCT04256200 | Unknown Phase 2 DMC

• 1 other identifier: OGY.AA.07
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

endometriosis; oral contraceptive pills; progestin

Outcome Measures

Primary Outcomes (1)

• Endometriosis-associated pelvic pain

  be the absolute change in endometriosis -associated pelvic pain from baseline to end of treatment, assessed by the Visual Analogue Scale (VAS): with "absence of pain" corresponding to the value "0" and "unbearable pain" corresponding to the value "10"

  6 months

Secondary Outcomes (3)

• Impact on Quality of life

  6 months

• incidence of side effects

  6 months

• Patient Tolerability

  6 months

Study Arms (2)

Dienogest

ACTIVE COMPARATOR

Deinogest (Visanne) 2mg/day orally for 24 weeks

Drug: Dienogest 2 MG Oral Tablet

Oral Contraceptive Pills

ACTIVE COMPARATOR

Oral contraceptive pill (Yasmin, 0.03mg Ethinyl Estradiol and 3mg Drospirenone) orally daily for 24 weeks

Drug: Yasmin

Interventions

Dienogest 2 MG Oral Tablet DRUG

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

Also known as: Visanne

Dienogest

Yasmin DRUG

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

Also known as: combined oral contraceptive

Oral Contraceptive Pills

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut

Beirut, Lebanon

RECRUITING

Related Publications (1)

• El Taha L, Abu Musa A, Khalifeh D, Khalil A, Abbasi S, Nassif J. Efficacy of dienogest vs combined oral contraceptive on pain associated with endometriosis: Randomized clinical trial. Eur J Obstet Gynecol Reprod Biol. 2021 Dec;267:205-212. doi: 10.1016/j.ejogrb.2021.10.029. Epub 2021 Oct 30.

  PMID: 34826668 DERIVED

MeSH Terms

Conditions

Endometriosis

Interventions

dienogest; Tablets; drospirenone and ethinyl estradiol combination; Contraceptives, Oral, Combined

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Drug Combinations; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Officials

• Antoine Abu Musa, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antoine Abu Musa, M.D.

CONTACT

+9611350000; aa06@aub.edu.lb

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology/principal investigator

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: February 5, 2020
• Study Start: February 7, 2017
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 15, 2021

Record last verified: 2021-04

Locations

LE (1)