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

Adenomyosis Clinical Trial

— LNG-IUDvsCOCs  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03037944
• Other study ID #: ASAD0316
• Status: Recruiting
• Phase: N/A
• First received: July 10, 2016
• Last updated: January 28, 2017
• Start date: March 1, 2016
• Est. completion date: December 1, 2018

Study information

• Verified date: January 2017
• Source: Ain Shams Maternity Hospital
• Contact: Asmaa Ma Mohamdy, Bachelor
• Phone: +201008340829
• Email: dr.asmaamamdoh[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenomyosis

Intervention

Drug:
• Yasmin
(ethinyl estradiol 0.03 mg/ drospirenone 3 mg) tablets

Device:
• Metraplant-E
Levonorgestrel-releasing Intrauterine System modified levonorgestrel-releasing intrauterine system from the old IUD "Metraplant", modified by Azzam 2013

Locations

Country	Name	City	State
Egypt	Ain Shams University - Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Benagiano G, Brosens I, Habiba M. Structural and molecular features of the endomyometrium in endometriosis and adenomyosis. Hum Reprod Update. 2014 May-Jun;20(3):386-402. doi: 10.1093/humupd/dmt052. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of pain by pain measurement score	measurement of the pain score by questionnaire form filled by patients. this questionnaire is evaluated by numbers corresponding to each answer chosen by patients	6 Months
Primary	Number of bleeding days	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	6 Months