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

February 18, 2026 updated by: Ahmed Abdel Latif Ahmed Alnezamy, Benha University

Oral Contraceptive Pills Versus Levonorgestrel-Releasing Intrauterine System for the Management of Niche-Related Abnormal Uterine Bleeding: A Prospective Open-Label Randomized Controlled Trial

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After eligibility and consenting, participants were randomized in a 1:1 ratio using a computer-generated block randomization list (block size of six). Allocation concealment was maintained using sequentially numbered, opaque, sealed envelopes, which were opened after consent.

All participants had a transvaginal ultrasound-confirmed uterine niche ≥2 mm in depth. Residual myometrial thickness, niche depth, length, and width were assessed.

  • OCP group: Participants received a monophasic combined oral contraceptive pill containing 0.03 mg ethinyl estradiol and 3 mg drospirenone (Technospiron® 0.03/3 mg, Technopharm, Egypt), taken for 21 days starting on day 2 of menstruation for six consecutive cycles.
  • LNG-IUS group: Participants received a 52 mg levonorgestrel-releasing intrauterine system (Mirena®, Bayer, Oy Finland), inserted under transvaginal ultrasound guidance within the first three days of menstruation for 6 months.

Both treatments were provided free of charge. Participants could switch to the alternative method upon study completion. Because of the nature of the interventions, blinding was not feasible; hence, the trial was open-label. Assessments were performed at baseline and at 1, 3, and 6 months. Participants recorded:

  • Number of days of postmenstrual/intermenstrual spotting
  • Total bleeding duration per cycle
  • Pelvic pain and dysmenorrhea scores (10-point visual analogue scale)
  • Sexual well-being (FSFI-6 score)
  • Treatment satisfaction (satisfied/very satisfied vs. other responses)
  • Adverse events, complications, and reasons for discontinuation (including LNG-IUS expulsion) At 6 months, transvaginal ultrasonography was repeated to assess residual myometrial thickness, niche depth, length, and width.

Study Type

Interventional

Enrollment (Actual)

166

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Qalyubia Governorate
      • Banhā, Qalyubia Governorate, Egypt, 13512
        • Benha Univesity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: combined oral contraceptive pill group
Participants received a monophasic combined oral contraceptive pill 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.
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.
Other Names:
  • Technospiron
Active Comparator: levonorgestrel-releasing intrauterine system group
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.
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.
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.
Other Names:
  • Mirena

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in the total number of postmenstrual and/or intermenstrual spotting days per cycle at 6 months post randomization from baseline.
Time Frame: at baseline and at 6 months post randomization
Participants had recorded daily bleeding data in structured, paper menstrual diaries that were prospectively given to them with proper guidance of how to fill them in a right way and then they were reviewed for completeness during follow-up visits/calls.
at baseline and at 6 months post randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pelvic pain scores
Time Frame: at baseline and at 1, 3, and 6 months
Participants recorded this on 10-point visual analogue scale where 0 means no pain and 10 means intense pain.
at baseline and at 1, 3, and 6 months
The total number of postmenstrual and/or intermenstrual spotting days per cycle.
Time Frame: at baseline and at 1, 3, and 6 months post randomization
Participants had recorded daily bleeding data in structured, paper menstrual diaries that were prospectively given to them with proper guidance of how to fill them in a right way and then they were reviewed for completeness during follow-up visits/calls.
at baseline and at 1, 3, and 6 months post randomization
Total bleeding duration per cycle
Time Frame: at baseline and at 1, 3, and 6 months post randomization
Participants had recorded daily bleeding data in structured, paper menstrual diaries that were prospectively given to them with proper guidance of how to fill them in a right way and then they were reviewed for completeness during follow-up visits/calls. It includes days of menstruation plus days of spotting
at baseline and at 1, 3, and 6 months post randomization
dysmenorrhea scores
Time Frame: at baseline and at 1, 3, and 6 months post randomization
Participants recorded this on 10-point visual analogue scale where 0 means no pain and 10 means intense pain.
at baseline and at 1, 3, and 6 months post randomization
Sexual function
Time Frame: at baseline and at 1, 3, and 6 months post randomization
Assessed using the validated 6-item Female Sexual Function Index (FSFI-6). The FSFI-6 score is the sum of the participant ordinal responses to the six items; the score can range from 2 to 30. Female sexual dysfunction is diagnosed if the total score is ≤ 19 (Isidori et al., J Sex Med 2010)
at baseline and at 1, 3, and 6 months post randomization
Treatment satisfaction
Time Frame: at 1, 3, and 6 months post randomization
Participants recorded on a 5-point Likert scale (where 1 means very dissatisfied and 5 means very satisfied), then dichotomized for analysis as yes for "Satisfied/Very Satisfied" and no for other responses.
at 1, 3, and 6 months post randomization
Anatomical Niche Changes
Time Frame: at baseline and at 6 months post randomization
Assessed via transvaginal ultrasonography including residual myometrial thickness, niche depth, length, and width.
at baseline and at 6 months post randomization
Adverse events
Time Frame: at 1, 3, and 6 months post randomization
Participants reported this to the main investigator via follow up visits or telephone calls
at 1, 3, and 6 months post randomization
Complications
Time Frame: At 1, 3, and 6 months post randomization
Participants reported this to the main investigator via follow up visits or telephone calls
At 1, 3, and 6 months post randomization
Reasons for discontinuation
Time Frame: At 1, 3, and 6 months post randomization
Participants reported this to the main investigator via follow up visits or telephone calls
At 1, 3, and 6 months post randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Investigators

  • Principal Investigator: AHMED ALNEZAMY, MD, Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Benha University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2025

Primary Completion (Actual)

May 1, 2025

Study Completion (Actual)

November 1, 2025

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

November 13, 2025

First Posted (Actual)

November 14, 2025

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC10-2-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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