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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-08-31

Brief Summary

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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.

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Detailed Description

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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

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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levonorgestrel & etonogestrel

Levonorgestrel releasing intrauterine system

Other names:

Mirena.

Group Type EXPERIMENTAL

Levonorgestrel

Intervention Type DRUG

20μg/day.

etonogestrel

Etonogestrel implant:

Other name: Implanon Releasing 20μg/day.

Group Type ACTIVE_COMPARATOR

Etonogestrel

Intervention Type DRUG

20μg/day.

Interventions

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Levonorgestrel

20μg/day.

Intervention Type DRUG

Etonogestrel

20μg/day.

Intervention Type DRUG

Other Intervention Names

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levonorgestrel releasing intrauterine system Mirena Implanon

Eligibility Criteria

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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 Enzian classification.
* Accept participate and sign the consent form and clarified

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes