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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| levonorgestrel & etonogestrel | Experimental | Levonorgestrel releasing intrauterine system Other names: Mirena. |
|
| etonogestrel | Active Comparator | Etonogestrel implant: Other name: Implanon Releasing 20μg/day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel | Drug | 20μg/day. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Cancer antigen 125 |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nelsilene Tavares, MD | University of Campinas, Brazil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nelsilene Mota Carvalho | Campinas | São Paulo | 13083887 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19041438 | Background | 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. | |
| 15720856 | Background |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 29, 2018 | |
| Unrelease | Yes | |
| Release | May 3, 2018 | |
| Reset | Nov 30, 2018 | |
| Release | Mar 5, 2020 | |
| Reset | Mar 19, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 29, 2018 | Yes | |||
| May 3, 2018 |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| C044815 | etonogestrel |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 |
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| Etonogestrel | Drug | 20μg/day. |
|
|
Ca 125 will be evaluated at baseline and at last follow-up ( +/- 180 days). |
| Baseline and after 180 days |
| 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. |
| 23929199 | 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. |
| 21106059 | 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. |
| 30396557 | Derived | 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. |
| Nov 30, 2018 |
| Mar 5, 2020 | Mar 19, 2020 |
| D000091662 | Genital Diseases |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |