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

NCT03037944 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-01-31

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Ain Shams Maternity Hospital

    lead OTHER

Principal Investigators

  • Mohamed Es Abbas, Lecturer · Ain Shams University - Maternity Hospital

  • Karim Mo Labib, Lecturer · Ain Shams University - Maternity Hospital

  • Karim AH Labib, Assistant · Ain Shams University - Maternity Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-01
Primary Completion
2017-12-01
Completion
2018-12-01
FDA Drug
Yes
FDA Device
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03037944 on ClinicalTrials.gov