Menstrual Pattern Within Six Months of Levonogestrel IUS Insertion

Not yet recruiting

• Conditions: Contraception

• Registration Number: NCT06577168
• Lead Sponsor: Assiut University

Brief Summary

The purpose of this study is to systematically calculate the mean number of bleeding-only, spotting-only, and bleeding and/or spotting days experienced by a population of reproductive aged,52 mg levonogestrel Intrauterine System(LNG-IUS) users.

Detailed Description

The levonogestrel Intrauterine system (LNG-IUS)(52 mg per 20mg per day release) is associated with medically benign changes to the menstrual pattern. Amenorrhea, the complete cessation of vaginal bleeding for at least 90 consecutive days, is perhaps the most extreme bleeding pattern experienced by some users during the first year. Amenorrhea prevalence is positively associated with duration of use, with approximately 8% of users.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-08-27
• Last Update Submitted: 2024-08-27
• Study First Posted: 2024-08-29
• Last Update Posted: 2024-08-29
• Study Start: 2024-12-01
• Primary Completion: 2025-12
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• Included participants with normal regular menses prior to LNG-IUS

insertion

• Included participants of any age, race, ethnicity, or parity
• Contained bleeding and/or spotting data on the 52 mg (20 mg/d) LNG-IUS
• Collected daily menstrual bleeding data from written diaries for at least 90 consecutive days

Exclusion Criteria

• Heavy or prolonged menstrual bleeding (menorrhagia)
• Actively breastfeeding
• Hormonal long-acting reversible contraceptive method (LNG-IUS, implant) within 3 months of enrollment
• Hormonal injectable contraceptive use within 6 months of enrollment
• First 3 months (90 days) of data from women with postpartum or postabortion LNG-IUS insertions
• Any anatomical or pathological condition (ie, uterine fibroids) that may have an impact on baseline menstrual bleeding pattern

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean number of days with menstrual bleeding changes	Six months after insertion of levonogestrel Intrauterine system	This include calculating the average number of days per month with bleeding-only, spotting-only,and bleeding and/or spotting in reproductive aged women using a 52 mg levonogestrel Intrauterine system (LNG-IUS) within the first six months ofuse, according to World Health Organization standards.

Trial Locations

Locations (1)

Assuit University; 🇪🇬 Assiut, Egypt