Clinical Trial the Use of Levonorgestrel-releasing Intrauterine System Versus Etonogestrel Implant in Endometriosis

NCT02480647 | Completed Phase 4 DMC

• 1 other identifier: 44827415200005404
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized clinical trial the use of levonorgestrel releasing intrauterine system. Objectives: To evaluate and compare the efficacy of- levonorgestrel releasing intrauterine system l(LNG-IUS) in relation to the subdermal implant releasing etonogestrel (ENG) in the control of chronic pelvic pain and / or dysmenorrhea in women endometriosis.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• Pelvic pain. Pain intensity measure: Self reported pain intensity daily. each item scored 0-10.

  Self reported pain intensity in the morning, afternoon, evening and winch activity over. Each item is scored 0-10. ( 0=no pain; 10= pain as bad as can be.

  6 months

Secondary Outcomes (2)

• Uterine bleeding

  6 months

• Cancer antigen 125

  Baseline and after 180 days

Study Arms (2)

levonorgestrel & etonogestrel

EXPERIMENTAL

Levonorgestrel releasing intrauterine system Other names: Mirena.

Drug: Levonorgestrel

etonogestrel

ACTIVE COMPARATOR

Etonogestrel implant: Other name: Implanon Releasing 20μg/day.

Drug: Etonogestrel

Interventions

Levonorgestrel DRUG

20μg/day.

Also known as: levonorgestrel releasing intrauterine system, Mirena

levonorgestrel & etonogestrel

Etonogestrel DRUG

20μg/day.

Also known as: Implanon

etonogestrel

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18 to 45
• Absence of pregnancy
• Patients with chronic pelvic pain and / or dysmenorrhea with pain scores ≥ 4 on EVA pain and surgical and histopathological diagnosis of endometriosis in 14 last three months to two years, according to the current classification of the American Society for Reproductive Medicine and Enzian classification.
• Accept participate and sign the consent form and clarified

You may not qualify if:

• Current wish to get pregnant
• I just want to use the LNG-IUS as treatment
• Contraindication to the use of LNG-IUS: Current pelvic inflammatory disease or appellant; infection of the lower genital tract; infected abortion during the last 3 months; purulent cervicitis; uterine or cervical malignancy; bleeding abnormal uterine undiagnosed; congenital uterine anomalies or acquired conditions associated with increased susceptibility to infections; acute liver disease or liver tumors; hypersensitivity to LNG.
• Contraindications to the use of ENG implants: pregnancy or suspected pregnancy;
• Active venous thromboembolic disorder; presence or history of liver disease serious as liver function values have not returned to normal; progestogen dependent tumors; abnormal bleeding undiagnosed; hypersensitivity to any component of implante.
• Abusive use of alcohol and / or other illicit drugs.

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

Nelsilene Mota Carvalho

Campinas, São Paulo, 13083887, Brazil

Location

Related Publications (5)

• Walch K, Unfried G, Huber J, Kurz C, van Trotsenburg M, Pernicka E, Wenzl R. Implanon versus medroxyprogesterone acetate: effects on pain scores in patients with symptomatic endometriosis--a pilot study. Contraception. 2009 Jan;79(1):29-34. doi: 10.1016/j.contraception.2008.07.017. Epub 2008 Sep 25.

  PMID: 19041438 BACKGROUND

• Yisa SB, Okenwa AA, Husemeyer RP. Treatment of pelvic endometriosis with etonogestrel subdermal implant (Implanon). J Fam Plann Reprod Health Care. 2005 Jan;31(1):67-70. doi: 10.1783/0000000052972799.

  PMID: 15720856 BACKGROUND

• Zomer MT, Ribeiro R, Trippia CH, Cavalcanti TC, Hayashi RM, Kondo W. [Correlation between serum Ca-125 levels and surgical findings in women with symptoms evocative of endometriosis]. Rev Bras Ginecol Obstet. 2013 Jun;35(6):262-7. doi: 10.1590/s0100-72032013000600005. Portuguese.

  PMID: 23929199 BACKGROUND

• Gerlinger C, Schumacher U, Faustmann T, Colligs A, Schmitz H, Seitz C. Defining a minimal clinically important difference for endometriosis-associated pelvic pain measured on a visual analog scale: analyses of two placebo-controlled, randomized trials. Health Qual Life Outcomes. 2010 Nov 24;8:138. doi: 10.1186/1477-7525-8-138.

  PMID: 21106059 BACKGROUND

• Carvalho N, Margatho D, Cursino K, Benetti-Pinto CL, Bahamondes L. Control of endometriosis-associated pain with etonogestrel-releasing contraceptive implant and 52-mg levonorgestrel-releasing intrauterine system: randomized clinical trial. Fertil Steril. 2018 Nov;110(6):1129-1136. doi: 10.1016/j.fertnstert.2018.07.003.

  PMID: 30396557 DERIVED

MeSH Terms

Conditions

Endometriosis

Interventions

Levonorgestrel; etonogestrel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Nelsilene Tavares, MD

  University of Campinas, Brazil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Carvalho NM

Study Record Dates

• First Submitted: June 17, 2015
• First Posted: June 24, 2015
• Study Start: May 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 14, 2017

Record last verified: 2017-06

Locations

BR (1)