Menstrual Pattern Within Six Months of Levonogestrel IUS Insertion
The Prevalence and Predictors of Menstrual Pattern Within Six Months of Levonogestrel IUS Insertion.
1 other identifier
observational
300
1 country
1
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.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for all trials
Started Dec 2024
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2024
CompletedFirst Posted
Study publicly available on registry
August 29, 2024
CompletedStudy Start
First participant enrolled
December 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedAugust 29, 2024
August 1, 2024
1 year
August 27, 2024
August 27, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Mean number of days with menstrual bleeding changes
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.
Six months after insertion of levonogestrel Intrauterine system
Interventions
Contraception method
Eligibility Criteria
Females at reproductive age (18-45)
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assuit University
Asyut, 088, Egypt
Related Publications (1)
Maldonado LY, Sergison JE, Gao X, Hubacher D. Menstrual bleeding and spotting with the Levonorgestrel Intrauterine System (52 mg) during the first-year after insertion: a systematic review and meta-analysis. Am J Obstet Gynecol. 2020 May;222(5):451-468.e9. doi: 10.1016/j.ajog.2019.09.044. Epub 2019 Oct 4.
PMID: 31589865BACKGROUND
Study Officials
- STUDY DIRECTOR
Seif E Ahmed, Professor
Assiut University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident doctor
Study Record Dates
First Submitted
August 27, 2024
First Posted
August 29, 2024
Study Start
December 1, 2024
Primary Completion
December 1, 2025
Study Completion
May 1, 2026
Last Updated
August 29, 2024
Record last verified: 2024-08