NCT07229209

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Benha University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Abnormal Uterine Bleeding
• Cesarean Section Complications
• Uterine Scar

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-02-05
• Primary completion: 2025-05-01
• Completion: 2025-11-01
• First posted: 2025-11-14
• Last updated: 2026-02-20

Locations

1 site across 1 country: Egypt