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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

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.

Condition or disease Intervention/treatment Phase
Adenomyosis Drug: Yasmin Device: Metraplant-E Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Levonorgestrel-releasing Intrauterine System Versus a Low-dose Combined Oral Contraceptive for Management of Adenomyosis Uteri
Actual Study Start Date : March 1, 2016
Estimated Primary Completion Date : December 1, 2017
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: drospirenone and ethinyl estradiol tablets




Primary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   30 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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): NCT03037944


Contacts
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Contact: Asmaa Ma Mohamdy, Bachelor +201008340829 dr.asmaamamdoh@gmail.com
Contact: Mohamed Es Abbas, Lecturer +201007644642 moh_3smat@yahoo.com

Locations
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Egypt
Ain Shams University - Maternity Hospital Recruiting
Cairo, Egypt
Contact: Asmaa MA Mohamdy, Bachelors    +201008340829    dr.asmaamamdoh@gmail.com   
Principal Investigator: Karim Ah Wahba, Asst.Prof         
Sub-Investigator: Karim Mo Labib, Lecturer         
Sub-Investigator: Mohamed Es Abbass, Lecturer         
Sponsors and Collaborators
Ain Shams Maternity Hospital
Investigators
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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 of Results:
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Responsible Party: Asmaa Mamdoh Mohamdy, Researcher, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT03037944     History of Changes
Other Study ID Numbers: ASAD0316
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Asmaa Mamdoh Mohamdy, Ain Shams Maternity Hospital:
Adenomyosis
Contraceptive pills
Levonorgestrel-releasing Intrauterine System
Additional relevant MeSH terms:
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Drospirenone
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Drospirenone and ethinyl estradiol combination
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Adenomyosis
Uterine Diseases
Genital Diseases, Female
Contraceptive Agents
Levonorgestrel
Contraceptives, Oral
Contraceptives, Oral, Combined
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents