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EndometriosisPhase 4NCT02480647

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

A Phase 4 study testing Levonorgestrel and Etonogestrel in people with Endometriosis, run by University of Campinas, Brazil at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Endometriosis
What is being tested?
Levonorgestrel and Etonogestrel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteBrazil
Study dates
May 2016to Aug 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Nelsilene Mota Carvalho

    Campinas, São Paulo, 13083887

Other trials in Brazil

About this study

Official title: Randomized Clinical Trial the Use of Levonorgestrel-releasing Intrauterine System Versus Etonogestrel Implant in Pelvic Pain Control in Women With Endometriosis

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.

Read the detailed description

Randomized clinical trial the use of levonorgestrel releasing intrauterine system.

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

Methods: Will be assessed 103 women, aged 18-45 years, diagnosis of endometriosis confirmed by laparoscopy or laparotomy that presents chronic pelvic pain and / or dysmenorrhea. The study will be experimental, randomized , (5' women will be allocated to the LNG-IUS and 52 women will use the implant subdermal ENG). Women will be invited to participate in the study on the day and having the Family Planning Clinic with pelvic pain complaints and / or dysmenorrhea with a confirmed diagnosis of endometriosis in search of inserting a LNG-IUS. That day will be invited to be allocated by lottery (through a system of computer generated randomization; with opaque and sealed envelopes), the group that will use LNG-IUS or subdermal implant ENG. At the inclusion in the study will be held the insertion of the LNG-IUS or ENG implant and on this day the pain will be evaluated by visual analogue scale (VAS) of pain and applied the evaluation questionnaire of endometriosis. It will be a calendar to record delivered daily bleeding and EVA for daily assessment of pain. Women will return each 30 days (± 3 days) where the pain of registration will be evaluated by EVA and will be collected the bleeding and delivered a new calendar for the next 30 days. The end of the study It is expected to 180 days post-insertion of the LNG-IUS or the implant and, in the latter evaluation, will again be applied questionnaire. Cancer antigen 125 (CA-125), CD23 and endometrial biopsy will be evaluated at baseline and at last follow-up ( +/- 180 days).

Inclusion criteria:

  • 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
  • Accept participate and sign the consent form and clarified.
Conditions
Endometriosis
Being tested
Levonorgestrel, Etonogestrel
Medical subject headings
Endometriosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LevonorgestrelDrug

    Also called levonorgestrel releasing intrauterine system, Mirena

    20μg/day.

  • EtonogestrelDrug

    Also called Implanon

    20μg/day.

Study groups in NCT02480647
Study groupRoleWhat they receive
levonorgestrel & etonogestrelExperimentalLevonorgestrel releasing intrauterine system Other names: Mirena.
Receives: Drug: Levonorgestrel
etonogestrelActive comparatorEtonogestrel implant: Other name: Implanon Releasing 20μg/day.
Receives: Drug: Etonogestrel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (2)

  1. Uterine bleeding

    Self reported uterine bleeding in the morning, evening and which activity over. Each item is noted in menstrual calendar. ( 0=no bleeding; 1= spotting; 2- light and 3= intense, noted by the participant in menstrual calendar daily

    Measured: 6 months

  2. Cancer antigen 125

    Ca 125 will be evaluated at baseline and at last follow-up ( +/- 180 days).

    Measured: Baseline and after 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2015 (estimated)
  2. Study startMay 2016
  3. Primary completionAug 2017
  4. Study completionAug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02480647
Sponsor's protocol ID
44827415200005404
Status last verified
Jun 2017
First submitted
17 Jun 2015
Last updated
14 Aug 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19041438

  • 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.

    PubMed 15720856

  • 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.

    PubMed 23929199

  • 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.

    PubMed 21106059

  • 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.

    PubMed 30396557

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Levonorgestrel and Etonogestrel in people with Endometriosis, run by University of Campinas, Brazil at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pelvic pain. Pain intensity measure: Self reported pain intensity daily. each item scored 0-10. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02480647, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2017.

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