Status:
NOT_YET_RECRUITING
Menstrual Pattern Within Six Months of Levonogestrel IUS Insertion
Lead Sponsor:
Assiut University
Conditions:
Contraception
Eligibility:
FEMALE
18-45 years
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 levon...
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 blee...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06577168
Start Date
December 1 2024
End Date
May 1 2026
Last Update
August 29 2024
Active Locations (1)
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1
Assuit University
Asyut, Egypt, 088