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

NCT07229209 | Completed

• 1 other identifier: RC10-2-2025
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief 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; Uterine Scar; Cesarean Section Complications

Keywords

cesarean scar defect; Uterine niche; abnormal uterine bleeding; oral contraceptive pills; levonorgestrel intrauterine system; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (10)

• The total number of postmenstrual and/or intermenstrual spotting days per cycle.

  at baseline and at 1, 3, and 6 months post randomization

• Total bleeding duration per cycle

  at baseline and at 1, 3, and 6 months post randomization

• Pelvic pain scores

  at baseline and at 1, 3, and 6 months

• dysmenorrhea scores

  at baseline and at 1, 3, and 6 months post randomization

• Sexual function

  at baseline and at 1, 3, and 6 months post randomization

Study Arms (2)

combined oral contraceptive pill group

ACTIVE COMPARATOR

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; Drug: monophasic combined oral contraceptive pill

levonorgestrel-releasing intrauterine system group

ACTIVE COMPARATOR

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; Device: 52 mg levonorgestrel-releasing intrauterine system

Interventions

monophasic combined oral contraceptive pill DRUG

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.

Also known as: Technospiron

combined oral contraceptive pill group

transvaginal ultrasonography DIAGNOSTIC_TEST

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.

combined oral contraceptive pill group; levonorgestrel-releasing intrauterine system group

52 mg levonorgestrel-releasing intrauterine system DEVICE

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.

Also known as: Mirena

levonorgestrel-releasing intrauterine system group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha Univesity Hospital

Banhā, Qalyubia Governorate, 13512, Egypt

Location

Related Publications (14)

• Naji O, Abdallah Y, Bij De Vaate AJ, Smith A, Pexsters A, Stalder C, McIndoe A, Ghaem-Maghami S, Lees C, Brolmann HA, Huirne JA, Timmerman D, Bourne T. Standardized approach for imaging and measuring Cesarean section scars using ultrasonography. Ultrasound Obstet Gynecol. 2012 Mar;39(3):252-9. doi: 10.1002/uog.10077.

  PMID: 21858885 BACKGROUND

• Tulandi T, Cohen A. Emerging Manifestations of Cesarean Scar Defect in Reproductive-aged Women. J Minim Invasive Gynecol. 2016 Sep-Oct;23(6):893-902. doi: 10.1016/j.jmig.2016.06.020. Epub 2016 Jul 5.

  PMID: 27393285 BACKGROUND

• Vikhareva Osser O, Valentin L. Clinical importance of appearance of cesarean hysterotomy scar at transvaginal ultrasonography in nonpregnant women. Obstet Gynecol. 2011 Mar;117(3):525-532. doi: 10.1097/AOG.0b013e318209abf0.

  PMID: 21343754 BACKGROUND

• Donnez O. Cesarean scar defects: management of an iatrogenic pathology whose prevalence has dramatically increased. Fertil Steril. 2020 Apr;113(4):704-716. doi: 10.1016/j.fertnstert.2020.01.037.

  PMID: 32228874 BACKGROUND

• Jordans IPM, de Leeuw RA, Stegwee SI, Amso NN, Barri-Soldevila PN, van den Bosch T, Bourne T, Brolmann HAM, Donnez O, Dueholm M, Hehenkamp WJK, Jastrow N, Jurkovic D, Mashiach R, Naji O, Streuli I, Timmerman D, van der Voet LF, Huirne JAF. Sonographic examination of uterine niche in non-pregnant women: a modified Delphi procedure. Ultrasound Obstet Gynecol. 2019 Jan;53(1):107-115. doi: 10.1002/uog.19049.

  PMID: 29536581 BACKGROUND

• Isidori AM, Pozza C, Esposito K, Giugliano D, Morano S, Vignozzi L, Corona G, Lenzi A, Jannini EA. Development and validation of a 6-item version of the female sexual function index (FSFI) as a diagnostic tool for female sexual dysfunction. J Sex Med. 2010 Mar;7(3):1139-46. doi: 10.1111/j.1743-6109.2009.01635.x. Epub 2009 Dec 1.

  PMID: 19968774 BACKGROUND

• Stavridis K, Balafoutas D, Vlahos N, Joukhadar R. Current surgical treatment of uterine isthmocele: an update of existing literature. Arch Gynecol Obstet. 2025 Jan;311(1):13-24. doi: 10.1007/s00404-024-07880-w. Epub 2024 Dec 16.

  PMID: 39680143 RESULT

• Klein Meuleman SJM, Min N, Hehenkamp WJK, Post Uiterweer ED, Huirne JAF, de Leeuw RA. The definition, diagnosis, and symptoms of the uterine niche - A systematic review. Best Pract Res Clin Obstet Gynaecol. 2023 Aug;90:102390. doi: 10.1016/j.bpobgyn.2023.102390. Epub 2023 Jul 15.

  PMID: 37506497 RESULT

• Murji A, Sanders AP, Monteiro I, Haiderbhai S, Matelski J, Walsh C, Abbott JA, Munro MG, Maheux-Lacroix S; International Federation of Gynecology and Obstetrics (FIGO) Committee on Menstrual Disorders and Related Health Impacts. Cesarean scar defects and abnormal uterine bleeding: a systematic review and meta-analysis. Fertil Steril. 2022 Oct;118(4):758-766. doi: 10.1016/j.fertnstert.2022.06.031. Epub 2022 Aug 17.

  PMID: 35985862 RESULT

• You SH. The symptomatic cesarean scar defect with oral contraceptive pills treatment following evacuation of a cesarean scar pregnancy. Taiwan J Obstet Gynecol. 2023 Jan;62(1):181-183. doi: 10.1016/j.tjog.2022.04.012. No abstract available.

  PMID: 36720538 RESULT

• Chen YY, Tsai CC, Lan KC, Ou YC. Preliminary report on the use of a levonorgestrel intrauterine system for the treatment of intermenstrual bleeding due to previous cesarean delivery scar defect. J Obstet Gynaecol Res. 2019 Oct;45(10):2015-2020. doi: 10.1111/jog.14060. Epub 2019 Aug 5.

  PMID: 31381242 RESULT

• Zhang J, Zhu C, Yan L, Wang Y, Zhu Q, He C, He X, Ji S, Tian Y, Xie L, Liang Y, Xia W, Mol BW, Huirne JAF. Comparing levonorgestrel intrauterine system with hysteroscopic niche resection in women with postmenstrual spotting related to a niche in the uterine cesarean scar: a randomized, open-label, controlled trial. Am J Obstet Gynecol. 2023 Jun;228(6):712.e1-712.e16. doi: 10.1016/j.ajog.2023.03.020. Epub 2023 Mar 17.

  PMID: 36935068 RESULT

• Zhang X, Yang M, Wang Q, Chen J, Ding J, Hua K. Prospective evaluation of five methods used to treat cesarean scar defects. Int J Gynaecol Obstet. 2016 Sep;134(3):336-9. doi: 10.1016/j.ijgo.2016.04.011. Epub 2016 Jun 30.

  PMID: 27473332 RESULT

• Zheng F, Chen S, Yang W, Li J, Huang Q, Qin H, Wei J, Lin J. Comparison of the efficacy of oral contraceptives and levonorgestrel intrauterine system in intermenstrual bleeding caused by uterine niche. Ginekol Pol. 2024;95(8):621-626. doi: 10.5603/GP.a2023.0067. Epub 2023 Jul 7.

  PMID: 37417378 RESULT

MeSH Terms

Conditions

Metrorrhagia

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• AHMED ALNEZAMY, MD

  Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Benha University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Because of the nature of the interventions, blinding was not feasible; hence, the trial was open-label.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynecology, Faculty of Medicine

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 14, 2025
• Study Start: February 5, 2025
• Primary Completion: May 1, 2025
• Study Completion: November 1, 2025
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)