Levonorgestrel-releasing Intrauterine System Versus a Low-dose Combined Oral Contraceptive for Management of Adenomyosis Uteri (LNG-IUDvsCOCs)
Adenomyosis
About this trial
This is an interventional supportive care trial for Adenomyosis focused on measuring Adenomyosis, Contraceptive pills, Levonorgestrel-releasing Intrauterine System
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
Sites / Locations
- Ain Shams University - Maternity HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Group A-LNG
Group B-COCs
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.