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

NCT03037944 | Unknown Early Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: ASAD0316
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenomyosis

Keywords

Adenomyosis; Contraceptive pills; Levonorgestrel-releasing Intrauterine System

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Group A-LNG

EXPERIMENTAL

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

Group B-COCs

EXPERIMENTAL

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

Interventions

Yasmin DRUG

(ethinyl estradiol 0.03 mg/ drospirenone 3 mg) tablets

Also known as: drospirenone and ethinyl estradiol tablets

Group B-COCs

Metraplant-E DEVICE

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

Also known as: Metraplant-E- Levonorgestrel

Group A-LNG

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain Shams University - Maternity Hospital

Cairo, Cairo Governorate, Egypt

RECRUITING

Related Publications (1)

• Benagiano, G.; Brosens, I.; Habiba, M.

  RESULT

MeSH Terms

Conditions

Adenomyosis

Interventions

drospirenone and ethinyl estradiol combination; drospirenone; Ethinyl Estradiol

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Mohamed Es Abbas, Lecturer

  Ain Shams University - Maternity Hospital

  PRINCIPAL INVESTIGATOR

• Karim Mo Labib, Lecturer

  Ain Shams University - Maternity Hospital

  PRINCIPAL INVESTIGATOR

• Karim AH Labib, Assistant

  Ain Shams University - Maternity Hospital

  STUDY CHAIR

Central Study Contacts

Asmaa Ma Mohamdy, Bachelor

CONTACT

+201008340829; dr.asmaamamdoh@gmail.com

Mohamed Es Abbas, Lecturer

CONTACT

+201007644642; moh_3smat@yahoo.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: July 10, 2016
• First Posted: January 31, 2017
• Study Start: March 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: January 31, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)