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Oral Contraceptive Pills Versus Levonorgestrel-Releasing Intrauterine System for Niche-Related Abnormal Uterine Bleeding

NCT07229209 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2026-02-20

No results posted yet for this study

Summary

The purpose of the study is to compare the clinical efficacy and niche morphological changes following treatment with combined oral contraceptive pills (OCPs) versus a levonorgestrel-releasing intrauterine system (LNG-IUS) in women with symptomatic uterine niche-related abnormal uterine bleeding (AUB).

Conditions

  • Abnormal Uterine Bleeding
  • Cesarean Section Complications
  • Uterine Scar

Interventions

DIAGNOSTIC_TEST

transvaginal ultrasonography

At baseline and at 6 months after the start of treatment, transvaginal ultrasonography was performed to assess residual myometrial thickness, niche depth, length, and width.

DRUG

monophasic combined oral contraceptive pill

Participants received a monophasic combined oral contraceptive pills containing 0.03 mg ethinyl estradiol and 3 mg drospirenone (Technospiron® 0.03/3 mg, Technopharm, Egypt), starting on day 2-5 of menstruation for 21 days followed by a 7-day hormone-free interval, for six consecutive cycles.

DEVICE

52 mg levonorgestrel-releasing intrauterine system

Participants received a 52 mg levonorgestrel-releasing intrauterine system (Mirena®, Bayer, Oy Finland), inserted under transvaginal ultrasound guidance within the first 5 days of menstruation for 6 months.

Sponsors & Collaborators

  • Benha University

    lead OTHER

Principal Investigators

  • AHMED ALNEZAMY, MD · Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Benha University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-02-05
Primary Completion
2025-05-01
Completion
2025-11-01

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 NCT07229209 on ClinicalTrials.gov