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

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Brief Title

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

Official Title

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 Phase

Early Phase 1

Study Type

Interventional

Primary Outcome

Measurement of pain by pain measurement score

Condition

Adenomyosis

Intervention

Yasmin

Study Arms / Comparison Groups

 Group A-LNG
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

32

Start Date

March 1, 2016

Completion Date

December 1, 2018

Primary Completion Date

December 1, 2017

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

Gender

Female

Ages

30 Years - 45 Years

Accepts Healthy Volunteers

No

Contacts

Mohamed Es Abbas, Lecturer, +201008340829, [email protected]

Location Countries

Egypt

Location Countries

Egypt

Administrative Informations

NCT ID

NCT03037944

Organization ID

ASAD0316

Responsible Party

Principal Investigator

Study Sponsor

Ain Shams Maternity Hospital

Study Sponsor

Mohamed Es Abbas, Lecturer, Principal Investigator, Ain Shams University - Maternity Hospital

Verification Date

January 2017