ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02480647
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02480647
Recruitment Status : Completed
First Posted : June 24, 2015
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
Luis Bahamondes, University of Campinas, Brazil

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.


Condition or disease Intervention/treatment Phase
Endometriosis Drug: Levonorgestrel Drug: Etonogestrel Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial the Use of Levonorgestrel-releasing Intrauterine System Versus Etonogestrel Implant in Pelvic Pain Control in Women With Endometriosis
Actual Study Start Date : May 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: levonorgestrel & etonogestrel

Levonorgestrel releasing intrauterine system

Other names:

Mirena.

Drug: Levonorgestrel
20μg/day.
Other Names:
  • levonorgestrel releasing intrauterine system
  • Mirena

Active Comparator: etonogestrel

Etonogestrel implant:

Other name: Implanon Releasing 20μg/day.

Drug: Etonogestrel
20μg/day.
Other Name: Implanon




Primary Outcome Measures :
  1. Pelvic pain. Pain intensity measure: Self reported pain intensity daily. each item scored 0-10. [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Uterine bleeding [ Time Frame: 6 months ]
    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

  2. Cancer antigen 125 [ Time Frame: Baseline and after 180 days ]
    Ca 125 will be evaluated at baseline and at last follow-up ( +/- 180 days).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480647


Locations
Brazil
Nelsilene Mota Carvalho
Campinas, São Paulo, Brazil, 13083887
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
Principal Investigator: Nelsilene Tavares, MD University of Campinas, Brazil

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Luis Bahamondes, Carvalho NM, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT02480647     History of Changes
Other Study ID Numbers: 44827415200005404
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Levonorgestrel
Etonogestrel
Desogestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists