Clinical trial NCT03037944: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Adenomyosis
Keywords: Adenomyosis
Contraceptive pills
Levonorgestrel-releasing Intrauterine System
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2017-01-31
Enrollment: 32
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Measurement of pain by pain measurement score
timeFrame: 6 Months
measure: Number of bleeding days
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University - Maternity Hospital
Study officials:
affiliation: Ain Shams University - Maternity Hospital
name: Mohamed Es Abbas, Lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: Ain Shams University - Maternity Hospital
name: Karim Mo Labib, Lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: Ain Shams University - Maternity Hospital
name: Karim AH Labib, Assistant
role: STUDY_CHAIR
References:
citation: Benagiano, G.; Brosens, I.; Habiba, M.