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

Primary Purpose

Adenomyosis

Status
Unknown status
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Yasmin
Metraplant-E
Sponsored by
Ain Shams Maternity Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Adenomyosis focused on measuring Adenomyosis, Contraceptive pills, Levonorgestrel-releasing Intrauterine System

Eligibility Criteria

30 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ain Shams University - Maternity HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A-LNG

Group B-COCs

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Measurement of pain by pain measurement score
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
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

Secondary Outcome Measures

Full Information

First Posted
July 10, 2016
Last Updated
January 28, 2017
Sponsor
Ain Shams Maternity Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03037944
Brief Title
Levonorgestrel-releasing Intrauterine System Versus a Low-dose Combined Oral Contraceptive for Management of Adenomyosis Uteri
Acronym
LNG-IUDvsCOCs
Official Title
Levonorgestrel-releasing Intrauterine System Versus a Low-dose Combined Oral Contraceptive for Management of Adenomyosis Uteri
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
December 1, 2017 (Anticipated)
Study Completion Date
December 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams Maternity Hospital

4. Oversight

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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenomyosis
Keywords
Adenomyosis, Contraceptive pills, Levonorgestrel-releasing Intrauterine System

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A-LNG
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B-COCs
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Yasmin
Other Intervention Name(s)
drospirenone and ethinyl estradiol tablets
Intervention Description
(ethinyl estradiol 0.03 mg/ drospirenone 3 mg) tablets
Intervention Type
Device
Intervention Name(s)
Metraplant-E
Other Intervention Name(s)
Metraplant-E- Levonorgestrel
Intervention Description
Levonorgestrel-releasing Intrauterine System modified levonorgestrel-releasing intrauterine system from the old IUD "Metraplant", modified by Azzam 2013
Primary Outcome Measure Information:
Title
Measurement of pain by pain measurement score
Description
measurement of the pain score by questionnaire form filled by patients. this questionnaire is evaluated by numbers corresponding to each answer chosen by patients
Time Frame
6 Months
Title
Number of bleeding days
Description
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
Time Frame
6 Months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asmaa Ma Mohamdy, Bachelor
Phone
+201008340829
Email
dr.asmaamamdoh@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Es Abbas, Lecturer
Phone
+201007644642
Email
moh_3smat@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Es Abbas, Lecturer
Organizational Affiliation
Ain Shams University - Maternity Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karim Mo Labib, Lecturer
Organizational Affiliation
Ain Shams University - Maternity Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karim AH Labib, Assistant
Organizational Affiliation
Ain Shams University - Maternity Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Ain Shams University - Maternity Hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asmaa MA Mohamdy, Bachelors
Phone
+201008340829
Email
dr.asmaamamdoh@gmail.com
First Name & Middle Initial & Last Name & Degree
Karim Ah Wahba, Asst.Prof
First Name & Middle Initial & Last Name & Degree
Karim Mo Labib, Lecturer
First Name & Middle Initial & Last Name & Degree
Mohamed Es Abbass, Lecturer

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Benagiano, G.; Brosens, I.; Habiba, M.
Results Reference
result

Learn more about this trial

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

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