CompletedNot Applicable

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

Egypt166 participantsStarted 2025-02-05

Plain-language 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).

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * women with at least one previous cesarean section. * presenting with postmenstrual or intermenstrual bleeding for ≥3 consecutive cycles lasting ≥2 days, and a total bleeding duration \>7 days per cycle. * All participants had a transvaginal ultrasound-confirmed uterine niche ≥2 mm in depth. Exclusion Criteria: * pregnancy * malignancy * other identifiable causes of abnormal uterine bleeding * abnormal cervical cytology * cervicitis * pelvic inflammatory disease * endometrial polyps * uterine fibroids * contraindications to either combined oral contraceptive pill or levonorgestrel-releasing intrauterine system * desire for pregnancy * refusal to participate

What they're measuring

The change in the total number of postmenstrual and/or intermenstrual spotting days per cycle at 6 months post randomization from baseline.

Timeframe: at baseline and at 6 months post randomization

Trial details

NCT IDNCT07229209

SponsorBenha University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-01

View on ClinicalTrials.gov More Abnormal Uterine Bleeding trials