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

January 28, 2017 updated by: Asmaa Mamdoh Mohamdy, Ain Shams Maternity Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

32

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Ain Shams University - Maternity Hospital
        • Contact:
        • Principal Investigator:
          • Karim Ah Wahba, Asst.Prof
        • Sub-Investigator:
          • Karim Mo Labib, Lecturer
        • Sub-Investigator:
          • Mohamed Es Abbass, Lecturer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: Metraplant-E
Levonorgestrel-releasing Intrauterine System modified levonorgestrel-releasing intrauterine system from the old IUD "Metraplant", modified by Azzam 2013
Other Names:
  • Metraplant-E- Levonorgestrel
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.
Drug: Yasmin
(ethinyl estradiol 0.03 mg/ drospirenone 3 mg) tablets
Other Names:
  • drospirenone and ethinyl estradiol tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 Months
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
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams Maternity Hospital

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Benagiano, G.; Brosens, I.; Habiba, M.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

July 10, 2016

First Submitted That Met QC Criteria

January 28, 2017

First Posted (Estimate)

January 31, 2017

Study Record Updates

Last Update Posted (Estimate)

January 31, 2017

Last Update Submitted That Met QC Criteria

January 28, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASAD0316

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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