Levonorgestrel-releasing Intrauterine System Versus a Low-dose Combined Oral Contraceptive for Management of Adenomyosis Uteri
NCT ID: NCT03037944
Last Updated: 2017-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
32 participants
INTERVENTIONAL
2016-03-01
2018-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Metraplant-E
Levonorgestrel-releasing Intrauterine System modified levonorgestrel-releasing intrauterine system from the old IUD "Metraplant", modified by Azzam 2013
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.
Yasmin
(ethinyl estradiol 0.03 mg/ drospirenone 3 mg) tablets
Interventions
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Yasmin
(ethinyl estradiol 0.03 mg/ drospirenone 3 mg) tablets
Metraplant-E
Levonorgestrel-releasing Intrauterine System modified levonorgestrel-releasing intrauterine system from the old IUD "Metraplant", modified by Azzam 2013
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Severe underlying comorbidities (hepatic, oncological)
* Pelvic inflammatory disease
* Other cervical or uterine pathologies
* Deep venous thromboembolism
* Hormonal therapy contraindications
* Endometriosis or fibroid
30 Years
45 Years
FEMALE
No
Sponsors
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Ain Shams Maternity Hospital
OTHER
Responsible Party
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Asmaa Mamdoh Mohamdy
Researcher
Principal Investigators
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Mohamed Es Abbas, Lecturer
Role: PRINCIPAL_INVESTIGATOR
Ain Shams University - Maternity Hospital
Karim Mo Labib, Lecturer
Role: PRINCIPAL_INVESTIGATOR
Ain Shams University - Maternity Hospital
Karim AH Labib, Assistant
Role: STUDY_CHAIR
Ain Shams University - Maternity Hospital
Locations
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Ain Shams University - Maternity Hospital
Cairo, Cairo Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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Asmaa MA Mohamdy, Bachelors
Role: primary
References
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Benagiano, G.; Brosens, I.; Habiba, M.
Other Identifiers
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ASAD0316
Identifier Type: -
Identifier Source: org_study_id