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Trial record 33 of 408 for:    LEVONORGESTREL

Levonorgestrel-releasing Intrauterine System Versus a Low-dose Combined Oral Contraceptive for Management of Adenomyosis Uteri (LNG-IUDvsCOCs)

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ClinicalTrials.gov Identifier: NCT03037944
Recruitment Status : Unknown
Verified January 2017 by Asmaa Mamdoh Mohamdy, Ain Shams Maternity Hospital.
Recruitment status was:  Recruiting
First Posted : January 31, 2017
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Asmaa Mamdoh Mohamdy, Ain Shams Maternity Hospital

Tracking Information
First Submitted Date  ICMJE July 10, 2016
First Posted Date  ICMJE January 31, 2017
Last Update Posted Date January 31, 2017
Actual Study Start Date  ICMJE March 1, 2016
Estimated Primary Completion Date December 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2017)
  • Measurement of pain by pain measurement score [ Time Frame: 6 Months ]
    measurement of the pain score by questionnaire form filled by patients. this questionnaire is evaluated by numbers corresponding to each answer chosen by patients
  • Number of bleeding days [ Time Frame: 6 Months ]
    number of bleeding days is reported by patients and compared to pre- treatment conditions to evaluate the bleeding painful process duration and whether the intervention treatment had any relieving effect
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Levonorgestrel-releasing Intrauterine System Versus a Low-dose Combined Oral Contraceptive for Management of Adenomyosis Uteri
Official Title  ICMJE Levonorgestrel-releasing Intrauterine System Versus a Low-dose Combined Oral Contraceptive for Management of Adenomyosis Uteri
Brief Summary This study aims to compare the efficacy of LNG - IUD (Levonorgestrel releasing intrauterine device) Versus Low dose COCs (combined oral contraceptive pills) on management of heavy menstrual bleeding and Dysmenorrhea caused by Adenomyosis.
Detailed Description

Levonorgestrel releasing intrauterine device will be MetraPlant-E, which is used in this study in group A, is a modified Levonorgestrel -releasing intrauterine system from the old IUD - Intrauterine Device "Metraplant", MetraPlant-E design has a T-shaped frame containing Levonorgestrel and Ethylene Vinyl Acetate as well as Barium Sulphate to make it radio-opaque, All the "T" frame, the bulb of 20 mm length and sleeves contain: Ethylene Vinyl Acetate, Levonorgestrel and Barium Sulphate, which ensures more exposure of the endometrial surface to the system and hence expected more endometrial suppression.

It consists of Levonorgestrel Hormone (60 mg), Ethylene Vinyl Acetate (120 mg) & Barium Sulphate (20 mg) Metraplant-E is designed without any coat membrane, which will help in more rise in Levonorgestrel level (higher initial release). The high initial release of Levonorgestrel (reached more than 28µg/24hrs in Metraplant-E in this study of in-vitro release) may help in early stoppage of bleeding in patients who suffer from irregular bleeding.

Women in group A will receive IUD - Intrauterine Device- during menstruation .It will be inserted into uterus in similar procedure to non-hormonal IUD .Pelvic exam will be done, the vagina will hold open with speculum, grasping the cervix, measuring uterine length and proper insertion of IUD - Intrauterine Device by non-touch technic. Women will receive proper antibiotics after insertion.

Group B will receive combined oral contraceptive pills (Yasmin) which will be Monophasic pills have a constant dose of both estrogen and progestin in each of the hormonal active pills throughout the entire cycle . Yasmin (ethinyl estradiol 0.03 mg/ drospirenone 3 mg) tablets, it provides an oral contraceptive regimen, it will be used continuously for 6 months with stoppage after 3 months for withdrawal bleeding.

Both treatment arms (Metraplant E and Yasmin) will be followed up after 3 months and 6 month of patients' recruitment. Assessment of pain related symptoms will be done using visual analogue scale pain score, while assessment of menstrual improvement will be done using menstrual diary.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Adenomyosis
Intervention  ICMJE
  • Drug: Yasmin
    (ethinyl estradiol 0.03 mg/ drospirenone 3 mg) tablets
    Other Name: drospirenone and ethinyl estradiol tablets
  • Device: Metraplant-E
    Levonorgestrel-releasing Intrauterine System modified levonorgestrel-releasing intrauterine system from the old IUD "Metraplant", modified by Azzam 2013
    Other Name: Metraplant-E- Levonorgestrel
Study Arms  ICMJE
  • Experimental: Group A-LNG
    The Levonorgestrel releasing intrauterine device - IUD- will be Metraplant-E, which is used in this study for group A, is a modified Levonorgestrel-releasing intrauterine system from the old IUD "Metraplant", Metraplant-E design has a T-shaped frame containing Levonorgestrel and Ethylene Vinyl Acetate as well as Barium Sulphate to make it radio-opaque, All the "T" frame, the bulb of 20 mm length and sleeves contain: Ethylene Vinyl Acetate, Levonorgestrel and Barium Sulphate, ensure more exposure of the endometrial surface to the system and hence expect more endometrial suppression.
    Intervention: Device: Metraplant-E
  • Experimental: Group B-COCs
    Group B will receive combined oral contraceptive pills (Yasmin) COCs which will be Monophasic pills that have a constant dose of both estrogen and progestins in each of the hormonal active pills throughout the entire cycle . Yasmin (ethinyl estradiol 0.03 mg/ drospirenone 3 mg) tablets, provides an oral contraceptive regimen, it will be used continuously for 6 months with stoppage after 3 months for withdrawal bleeding.
    Intervention: Drug: Yasmin
Publications * Benagiano G, Brosens I, Habiba M. Structural and molecular features of the endomyometrium in endometriosis and adenomyosis. Hum Reprod Update. 2014 May-Jun;20(3):386-402. doi: 10.1093/humupd/dmt052. Epub 2013 Oct 18. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 28, 2017)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2018
Estimated Primary Completion Date December 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women patient aged 30-45 years
  • Diagnosed adenomyosis by transvaginal ultrasound or MRI or 3D ultrasound
  • Patient complains of heavy menstrual bleeding or dysmenorrhea or both
  • Living in a nearby area to make follow-up reasonably possible
  • Planning for birth spacing for at least 2 years.

Exclusion Criteria:

  • Pregnancy or seeking fertility
  • Severe underlying comorbidities (hepatic, oncological)
  • Pelvic inflammatory disease
  • Other cervical or uterine pathologies
  • Deep venous thromboembolism
  • Hormonal therapy contraindications
  • Endometriosis or fibroid
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 30 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03037944
Other Study ID Numbers  ICMJE ASAD0316
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Asmaa Mamdoh Mohamdy, Ain Shams Maternity Hospital
Study Sponsor  ICMJE Ain Shams Maternity Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mohamed Es Abbas, Lecturer Ain Shams University - Maternity Hospital
Principal Investigator: Karim Mo Labib, Lecturer Ain Shams University - Maternity Hospital
Study Chair: Karim AH Labib, Assistant Ain Shams University - Maternity Hospital
PRS Account Ain Shams Maternity Hospital
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP